chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Heart rate, Heart rate increased, Pyrexia
Clinical narrative: Elevated heart rate; that was floating heart that was all over the place it was inconsistent; my heart rate was at 150 and it was bouncing all over the place; white blood cells were high; Fever; temperature was 101; Headache; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program IBCC (Inbound Call Center for HCPs). A 66-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 04May2021 09:45 (Lot Number: ER8736) as second single dose at the age of 66-year-old for covid-19 immunization. Medical history included low thyroid/hypothyroidism. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for low thyroid/hypothyroidism, start and stop date were not reported. No prior vaccination within 4 weeks. The patient previously took BNT162B2 (Lot# EW0150) in left upper arm on 13Apr2021 09:45 am as the first single dose at the age of 66-year-old for COVID-19 immunisation. When after the patient get the second shot (05May2021) he had the fever and headache and held for two days and temperature was 101 Fahrenheit. Two weeks later (May2021), he ended up getting elevated heart rate for about two weeks. That was floating heart, all over the place it was inconsistent. And he had that about two weeks and he finally went to the hospital. The patient ended up in the hospital and they put him in for two weeks his heart rate was at 150 and it was bouncing all over the place and they send him home two days later. The patent still had the elevated heart rate. He was still taking medication for that he was going to back to the doctor for that in three weeks, not the 100 percent cured yet. He was still trying to be better. The patient was hospitalized for the event elevated heart rate from 02Jun2021 to 03Jun2021. Lab test showed the patient had a high rate of white blood cell. His white blood cells were high. Treatment for the event elevated heart rate included: two blood thinners, Eliquis 5mg, Metoprolol Tartrate 50 mg. Outcome of fever and headache was recovered, of heart rate increased was not recoevered, of white blood cells were high was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021660357 same reporter/drug/event, different patient
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count increased
Clinical narrative: Elevated heart rate; that was floating heart that was all over the place it was inconsistent; my heart rate was at 150 and it was bouncing all over the place; white blood cells were high; Fever; temperature was 101; Headache; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program IBCC (Inbound Call Center for HCPs). A 66-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 04May2021 09:45 (Lot Number: ER8736) as second single dose at the age of 66-year-old for covid-19 immunization. Medical history included low thyroid/hypothyroidism. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for low thyroid/hypothyroidism, start and stop date were not reported. No prior vaccination within 4 weeks. The patient previously took BNT162B2 (Lot# EW0150) in left upper arm on 13Apr2021 09:45 am as the first single dose at the age of 66-year-old for COVID-19 immunisation. When after the patient get the second shot (05May2021) he had the fever and headache and held for two days and temperature was 101 Fahrenheit. Two weeks later (May2021), he ended up getting elevated heart rate for about two weeks. That was floating heart, all over the place it was inconsistent. And he had that about two weeks and he finally went to the hospital. The patient ended up in the hospital and they put him in for two weeks his heart rate was at 150 and it was bouncing all over the place and they send him home two days later. The patent still had the elevated heart rate. He was still taking medication for that he was going to back to the doctor for that in three weeks, not the 100 percent cured yet. He was still trying to be better. The patient was hospitalized for the event elevated heart rate from 02Jun2021 to 03Jun2021. Lab test showed the patient had a high rate of white blood cell. His white blood cells were high. Treatment for the event elevated heart rate included: two blood thinners, Eliquis 5mg, Metoprolol Tartrate 50 mg. Outcome of fever and headache was recovered, of heart rate increased was not recoevered, of white blood cells were high was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021660357 same reporter/drug/event, different patient
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative, Diarrhoea, Eating disorder, Illness, Inappropriate schedule of product administration
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm right on 02Jun2021 around 2:00 to 3:00 pm (Batch/Lot number was not reported) as single dose at the age of 70-year-old for COVID-19 immunization. Medical history included lot of medical conditions, recovering from broken leg, blood pressure high treated before with Lisinopril and then with a new drug just prescribed, dissociative identity disorder, depression, anxiety, acid reflux, pain, neuralgia, had ulcerative colitis in the past (treated with medication). Family medical history included her mother had diarrhea very badly. Concomitant medication(s) included ziprasidone hydrochloride (GEODON, capsule) orally, twice a day, taken for dissociative identity disorder, start and stop date were not reported; tramadol (manufacturer unknown,  tab) 50 mg, twice a day, orally, taken for pain relief, start and stop date were not reported; hydroxyzine (manufacturer unknown) 25mg taken for nerve pain, start and stop date were not reported; clonazepam (manufacturer unknown, tablet) 1 mg, orally, taken for neuralgia, start and stop date were not reported. The patient previously received, lisinopril for hypertension. Vaccine history included BNT162B2 on 23Feb2021 for covid-19 immunization. No other vaccine administered together with BNT162B2.  In Jun2021 the patient experienced this is much worse than ulcerative colitis (medically significant) with outcome of unknown, diarrhoea (non-serious) with outcome of not recovered, she cannot eat anything without getting sick (non-serious) with outcome of unknown, she was very sick with diarrhea (non-serious) with outcome of unknown, she received BNT162B2 2st dose on 23Feb2021 and 2nd dose on 02Jun2021 (non-serious) with outcome of unknown. The course of events was as follows: She got the COVID019 vaccine on 02Jun2021 afternoon and she had diarrhea repetitive diarrhea ever since its uncontrolled diarrhea she had to wear diaper and on 04Jun2021 she had to wash her clothes several times and she lied on bed for a while she had to wash that cloth as well she was very sick with diarrhea and she was reading diarrhea can be result of the vaccine she cannot eat anything without getting sick and she did not know what to do. Treatment received in response to event diarrhoea: Pepto-Bismol during the day time, 2 Pepto-Bismol every 30 minutes; 262 mgs. Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Parkinson's disease
Clinical narrative: Patient acquired "Park" syndrome; This is spontaneous report from contactable consumer (patient). A patient of an unspecified age and gender received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EW0162) at single dose, on 15Apr2021, for COVID-19 immunization. Relevant medical history and concomitant medications were unknown. The patient previously on 25Mar2021 received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: ER8727) at single dose, for COVID-19 immunization. On an unspecified date, the patient stated that had been in hospital (12 days). Patient acquired "Park" syndrome (it was not further clarified if consumer meant Parkinson's disease or Parkes syndrome). Patient received blood transfusions. Further clarification was unknown. The patient did not recover from the adverse event at time of this report.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: he was showing reaction, chest pain and severe chest pain; This is a spontaneous report from a contactable consumer reporting on behalf of the son. A 21 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Jun2021, as second single dose, for COVID-19 immunization. The first dose of BNT162B2 was given on an unknown date. Medical history and concomitant medications were not reported. The patient took the second vaccine dose and he was showing reaction, chest pain and severe chest pain since an unspecified date in Jun2021. The reporter took him to ER because he was showing severe chest pain and he was 21 years old. Reporter seriousness for the event was unspecified. Event outcome was unknown.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Apnoea, Neck pain, Pain in extremity
Clinical narrative: Apnea; Underarm pain; Neck pain; This is a spontaneous report received from a contactable consumer (patient). A 38-year-old female patient received first dose of BNT162B2, via an unspecified route of administration, administered in Arm Right on 26Apr2021 around noon (Batch/Lot Number: ER8735) at age of 38-year-old as single dose for covid-19 immunisation. Patient's medical history was reported as none. Family medical history relevant to AEs was reported as none. The facility where patient received the COVID vaccine was vaccination facility type, other- community center, not administered at military facility. No additional vaccines administered on same date of the Pfizer suspect. No Prior Vaccinations within 4 weeks. The patient's concomitant medications were not reported. After the first dose, she had neck pain on 27Apr2021, underarm pain on 28Apr2021, apnea on 28Apr2021. Apnea at night time like someone was squeezing her throat or nose. It would wake her up and she immediately feels like she was choking. She would also have apnea in the afternoon while sleeping. Like if she took a nap, 30 minutes after sleeping she would have it, she also referred to as sleep apnea. It would be in the afternoon and nighttime. AEs requested emergency room.  Caller mentioned she had scheduled a check up with her ear doctor, and her regular physician. Neck Pain went away after 3-4 days. She did not know the exact date. Underarm pain went away after 2-3 days. She did not know the exact date. She noticed Apnea started the second day after the first dose. After the first dose it did not start to reduce a little, for a while she was able to sleep all day, but it was not completed gone. At end of call she commented she just wanted to sleep, but was scared due to the apnea. She was worried about her heart or something was going on with it. She felt it's odd and due to vaccine because she never had before. Before, she was healthy and this only started after the vaccine. The outcome of events neck pain and underarm pain was recovered in 2021, of event apnea was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Apnoea, Asthenia, Blood pressure measurement, Computerised tomogram head, Dyspnoea
Clinical narrative: Apnea; Underarm pain; Neck pain; This is a spontaneous report received from a contactable consumer (patient). A 38-year-old female patient received first dose of BNT162B2, via an unspecified route of administration, administered in Arm Right on 26Apr2021 around noon (Batch/Lot Number: ER8735) at age of 38-year-old as single dose for covid-19 immunisation. Patient's medical history was reported as none. Family medical history relevant to AEs was reported as none. The facility where patient received the COVID vaccine was vaccination facility type, other- community center, not administered at military facility. No additional vaccines administered on same date of the Pfizer suspect. No Prior Vaccinations within 4 weeks. The patient's concomitant medications were not reported. After the first dose, she had neck pain on 27Apr2021, underarm pain on 28Apr2021, apnea on 28Apr2021. Apnea at night time like someone was squeezing her throat or nose. It would wake her up and she immediately feels like she was choking. She would also have apnea in the afternoon while sleeping. Like if she took a nap, 30 minutes after sleeping she would have it, she also referred to as sleep apnea. It would be in the afternoon and nighttime. AEs requested emergency room.  Caller mentioned she had scheduled a check up with her ear doctor, and her regular physician. Neck Pain went away after 3-4 days. She did not know the exact date. Underarm pain went away after 2-3 days. She did not know the exact date. She noticed Apnea started the second day after the first dose. After the first dose it did not start to reduce a little, for a while she was able to sleep all day, but it was not completed gone. At end of call she commented she just wanted to sleep, but was scared due to the apnea. She was worried about her heart or something was going on with it. She felt it's odd and due to vaccine because she never had before. Before, she was healthy and this only started after the vaccine. The outcome of events neck pain and underarm pain was recovered in 2021, of event apnea was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Headache, Heart rate, Heart rate increased, Hypoaesthesia
Clinical narrative: Apnea; Underarm pain; Neck pain; This is a spontaneous report received from a contactable consumer (patient). A 38-year-old female patient received first dose of BNT162B2, via an unspecified route of administration, administered in Arm Right on 26Apr2021 around noon (Batch/Lot Number: ER8735) at age of 38-year-old as single dose for covid-19 immunisation. Patient's medical history was reported as none. Family medical history relevant to AEs was reported as none. The facility where patient received the COVID vaccine was vaccination facility type, other- community center, not administered at military facility. No additional vaccines administered on same date of the Pfizer suspect. No Prior Vaccinations within 4 weeks. The patient's concomitant medications were not reported. After the first dose, she had neck pain on 27Apr2021, underarm pain on 28Apr2021, apnea on 28Apr2021. Apnea at night time like someone was squeezing her throat or nose. It would wake her up and she immediately feels like she was choking. She would also have apnea in the afternoon while sleeping. Like if she took a nap, 30 minutes after sleeping she would have it, she also referred to as sleep apnea. It would be in the afternoon and nighttime. AEs requested emergency room.  Caller mentioned she had scheduled a check up with her ear doctor, and her regular physician. Neck Pain went away after 3-4 days. She did not know the exact date. Underarm pain went away after 2-3 days. She did not know the exact date. She noticed Apnea started the second day after the first dose. After the first dose it did not start to reduce a little, for a while she was able to sleep all day, but it was not completed gone. At end of call she commented she just wanted to sleep, but was scared due to the apnea. She was worried about her heart or something was going on with it. She felt it's odd and due to vaccine because she never had before. Before, she was healthy and this only started after the vaccine. The outcome of events neck pain and underarm pain was recovered in 2021, of event apnea was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: Apnea; Underarm pain; Neck pain; This is a spontaneous report received from a contactable consumer (patient). A 38-year-old female patient received first dose of BNT162B2, via an unspecified route of administration, administered in Arm Right on 26Apr2021 around noon (Batch/Lot Number: ER8735) at age of 38-year-old as single dose for covid-19 immunisation. Patient's medical history was reported as none. Family medical history relevant to AEs was reported as none. The facility where patient received the COVID vaccine was vaccination facility type, other- community center, not administered at military facility. No additional vaccines administered on same date of the Pfizer suspect. No Prior Vaccinations within 4 weeks. The patient's concomitant medications were not reported. After the first dose, she had neck pain on 27Apr2021, underarm pain on 28Apr2021, apnea on 28Apr2021. Apnea at night time like someone was squeezing her throat or nose. It would wake her up and she immediately feels like she was choking. She would also have apnea in the afternoon while sleeping. Like if she took a nap, 30 minutes after sleeping she would have it, she also referred to as sleep apnea. It would be in the afternoon and nighttime. AEs requested emergency room.  Caller mentioned she had scheduled a check up with her ear doctor, and her regular physician. Neck Pain went away after 3-4 days. She did not know the exact date. Underarm pain went away after 2-3 days. She did not know the exact date. She noticed Apnea started the second day after the first dose. After the first dose it did not start to reduce a little, for a while she was able to sleep all day, but it was not completed gone. At end of call she commented she just wanted to sleep, but was scared due to the apnea. She was worried about her heart or something was going on with it. She felt it's odd and due to vaccine because she never had before. Before, she was healthy and this only started after the vaccine. The outcome of events neck pain and underarm pain was recovered in 2021, of event apnea was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Erythema, Fatigue, Feeling abnormal
Clinical narrative: Hallucinations; Arm pain; Joint/lymph pain; joint/lymph pain; Splotchy red spots and itching; Splotchy red spots and itching; Felt like my arms and legs were not connected, a disconnected feeling to reality, like the world was moving around me, trees were closing in; Extreme fatigue; Could not hardly move; Slept for 2 days straight; Loss of appetite; Digestive issues; Feel a little out of sorts; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female (not pregnant) received second dose of BNT162B2 (lot number - EW0182) on Arm left on 20May2021 (at age of 55-year-old) 10:30 AM at single dose for Covid-19 immunisation. Medical history included Hypersensitive to meds, peanuts bother her, Splenic Hemangiomas, Hypoglycemia. Concomitant medications included paracetamol (TYLENOL) and origanum minutiflorum oil (OREGANO OIL). Historical vaccine included first dose of BNT162B2 (lot number -EW0170) on Arm Right on 29Apr2021 (55-year-old) 01:15 PM for Covid-19 immunisation and experienced some brain fog, arm pain, horrible joint/lymph gland pain, feeling of small needles poking me in the head, a disconnect with her arms and legs and fatigue. This lasted about 4 days. Facility where the most recent COVID-19 vaccine was administered:Doctor's office/urgent care. No other vaccines within 4 weeks prior to the COVID vaccine. The second vaccine had arm pain, joint/lymph pain, splotchy red spots and itching, felt like her arms and legs were not connected, a disconnected feeling to reality, like the world was moving around me, trees were closing in, and hallucinations. That last for 5 days. Then there was extreme fatigue... could not hardly move and slept for 2 days straight. At this point, I had a loss of appetite and digestive issues. Events onset date was 20May2021. All in all it last almost 2 weeks. Still feel a little out of sorts but feeling better. The outcome of the events was recovering. No treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Functional gastrointestinal disorder, Hallucination, Lymph node pain, Malaise, Movement disorder
Clinical narrative: Hallucinations; Arm pain; Joint/lymph pain; joint/lymph pain; Splotchy red spots and itching; Splotchy red spots and itching; Felt like my arms and legs were not connected, a disconnected feeling to reality, like the world was moving around me, trees were closing in; Extreme fatigue; Could not hardly move; Slept for 2 days straight; Loss of appetite; Digestive issues; Feel a little out of sorts; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female (not pregnant) received second dose of BNT162B2 (lot number - EW0182) on Arm left on 20May2021 (at age of 55-year-old) 10:30 AM at single dose for Covid-19 immunisation. Medical history included Hypersensitive to meds, peanuts bother her, Splenic Hemangiomas, Hypoglycemia. Concomitant medications included paracetamol (TYLENOL) and origanum minutiflorum oil (OREGANO OIL). Historical vaccine included first dose of BNT162B2 (lot number -EW0170) on Arm Right on 29Apr2021 (55-year-old) 01:15 PM for Covid-19 immunisation and experienced some brain fog, arm pain, horrible joint/lymph gland pain, feeling of small needles poking me in the head, a disconnect with her arms and legs and fatigue. This lasted about 4 days. Facility where the most recent COVID-19 vaccine was administered:Doctor's office/urgent care. No other vaccines within 4 weeks prior to the COVID vaccine. The second vaccine had arm pain, joint/lymph pain, splotchy red spots and itching, felt like her arms and legs were not connected, a disconnected feeling to reality, like the world was moving around me, trees were closing in, and hallucinations. That last for 5 days. Then there was extreme fatigue... could not hardly move and slept for 2 days straight. At this point, I had a loss of appetite and digestive issues. Events onset date was 20May2021. All in all it last almost 2 weeks. Still feel a little out of sorts but feeling better. The outcome of the events was recovering. No treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Somnolence
Clinical narrative: Hallucinations; Arm pain; Joint/lymph pain; joint/lymph pain; Splotchy red spots and itching; Splotchy red spots and itching; Felt like my arms and legs were not connected, a disconnected feeling to reality, like the world was moving around me, trees were closing in; Extreme fatigue; Could not hardly move; Slept for 2 days straight; Loss of appetite; Digestive issues; Feel a little out of sorts; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female (not pregnant) received second dose of BNT162B2 (lot number - EW0182) on Arm left on 20May2021 (at age of 55-year-old) 10:30 AM at single dose for Covid-19 immunisation. Medical history included Hypersensitive to meds, peanuts bother her, Splenic Hemangiomas, Hypoglycemia. Concomitant medications included paracetamol (TYLENOL) and origanum minutiflorum oil (OREGANO OIL). Historical vaccine included first dose of BNT162B2 (lot number -EW0170) on Arm Right on 29Apr2021 (55-year-old) 01:15 PM for Covid-19 immunisation and experienced some brain fog, arm pain, horrible joint/lymph gland pain, feeling of small needles poking me in the head, a disconnect with her arms and legs and fatigue. This lasted about 4 days. Facility where the most recent COVID-19 vaccine was administered:Doctor's office/urgent care. No other vaccines within 4 weeks prior to the COVID vaccine. The second vaccine had arm pain, joint/lymph pain, splotchy red spots and itching, felt like her arms and legs were not connected, a disconnected feeling to reality, like the world was moving around me, trees were closing in, and hallucinations. That last for 5 days. Then there was extreme fatigue... could not hardly move and slept for 2 days straight. At this point, I had a loss of appetite and digestive issues. Events onset date was 20May2021. All in all it last almost 2 weeks. Still feel a little out of sorts but feeling better. The outcome of the events was recovering. No treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperthyroidism, Investigation
Clinical narrative: My Hashimotos is off the chart suddenly Im HYPERthyroid after being consistently HYPOthyroid for last 20 years; suffered a pounding headache for a few days; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 63-year-old female patient received bnt162b2 (Pfizer BioNtech), dose 1 via an unspecified route of administration, administered in arm right on 14May2021 09:15 (Batch/Lot Number: EW0175) as 1st dose, single for covid-19 immunisation. Patient received second dose of bnt162b2, via an unspecified route of administration, administered in arm right on 03Jun2021 09:15 (Batch/Lot Number: EW0178) for covid-19 immunisation. Medical history included Hashimotos thyroiditis, spinal arthritis, high cholesterol, vasovagal syncope, pacemaker, and hypothyroidism (Being consistently Hypothyroid for the last 20 year), and known allergies: acetylsalicylic acid (ASPIRIN), nickel, latex, chalk. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (SYNTHROID), rosuvastatin, and Womens Multivitamin (patient received within 2 weeks of vaccination). Patient waited for the CDC to say its safe for autoimmune disorders. Got her 1st shot on 14May2021. Only suffered a pounding headache for a few days on May2021. Had her lab work done on 25May2021. Her Hashimotos was off the charts and suddenly she was hyperthyroid after being consistently hypothyroid for the last 20 years on 25May2021. Treatment received reported as medication adjustment, future titration as needed for hyperthyroid. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovered from event suffered a pounding headache for a few days. The outcome of other event was recovering. Serious reported as no.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Product preparation issue
Clinical narrative: undiluted vial of the Pfizer BioNtech covid 19 vaccine was drawn up and given to a patient in a single dose/ received a whole vial of contents that were undiluted; undiluted vial of the Pfizer BioNtech covid 19 vaccine was drawn up and given to a patient in a single dose/ received a whole vial of contents that were undiluted; This is a spontaneous report from a contactable pharmacist. A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8735; Expiration Date: 31Jul2021), dose 2 via an unspecified route of administration on 07Jun2021 09:00 (at the age of 36-year-old) as 2nd dose, 0.3 ml single dose for COVID-19 immunization. The patient medical history was none (Patient History: No). The patient's concomitant medications were none reported (Other Products: No). The patient previously received first dose of BNT162B2 (Lot Number: ER8734; Expiration Date: 31Jul2021) on 17May2021 for COVID-19 immunization. Pharmacist reported that an entire undiluted vial of the Pfizer BioNtech covid 19 vaccine was drawn up and given to a patient in a single dose (07Jun2021 at 09:00). Patient was informed of incident and monitored for 30 minutes. States when he got here this morning, one of his partners had administered an undiluted vial of contents to a patient without knowing he had to dilute it. Pharmacist stated he was calling to see if there was any further insight or anything else they need to do. Pharmacist states he had already done a VAERS report and an incident report on the end. Pharmacist clarified the patient received a whole vial of contents that were undiluted. Pharmacist states it had previously been unopened. Pharmacist stated this occurred today at 09:00 a.m. Treatment was none, states he seemed okay, and they kept him in the lobby. States it was his second dose in the series. Pharmacist again confirmed that patient was given 0.3mL of the undiluted vaccine out of the vial, and not the full 0.45mL. Just a single dose of undiluted vaccine. The patient was monitored and told to call if any adverse events developed. He was relaxed and calm during the monitoring and did not have any reaction. There was no investigation assessment. The outcome of events was unknown.; Sender's Comments: Based on the narrative information provided the events Overdose and Product preparation issue are related to BNT162B2 (COVID-19 mRNA VACCINE).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: I tested positive for Covid; I tested positive for Covid; This is a spontaneous report received from a contactable consumer (patient).  A patient of unspecified age and gender received second dose and first dose of BNT162B2 on unspecified date approx 6 months prior to the time of report at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Yesterday (03Jun2021) patient tested positive for Covid, patient had many symptoms. Fever, chills, sore throat, headache, fatigue, runny nose and cough. The doctors patient have seen say they have never seen a case like mine before. Patient would like to be tested by you to figure out why I am having breakthrough symptoms. Patient have no underlying conditions. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Facial bones fracture, Fall
Clinical narrative: ended up in the emergency room unable to stand and fall over and broke his nose in ER; Ended up in the emergency room unable to stand and fall over and broke his nose in ER; Unable to stand; This is a spontaneous report from a contactable consumer.  A 34-year-old male patient received BNT162B2 on unspecified date in Apr2021 (at age of 34-year-old) at single dose for COVID-19 immunization. Medical history included ongoing Primary progressive Multiple sclerosis and Hospitalized Flare up. Concomitant medications include fampridine (AMPYRA) from Apr2021 to unspecified date, dimethyl fumarate (TECFIDERA). On unknown date it was reported that patient experienced: ended up in the emergency room unable to stand and fall over and broke his nose in the ER. The outcome of the reported events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Hypothyroidism
Clinical narrative: My TSH thyroid number has always been below 2.0. After my first vaccine had symptoms of low thyroid worse after the 2nd. Got blood test and the value was 3.2 this is significant. Nothing in my life; This is a spontaneous report received from a contactable consumer (patient). A 59-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: ER8734), via an unspecified route of administration, administered in Arm Left on 20Apr2021 15:15 as 1st dose, single dose and second dose received via an unspecified route of administration, administered in Arm Left on 11May2021 15:15 (Batch/Lot Number: WE0170) as 2nd dose, single dose for covid-19 immunisation. Medical history included hashimoto thyroidist (had for over 20 years) from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium, sertraline hcl taken for an unspecified indication, start and stop date were not reported. The patient previously took Sulfa and experienced allergies. No other medical history was reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient reported that her TSH thyroid number had always been below 2.0. After her first vaccine had symptoms of low thyroid worse after the 2nd. Patient got blood test and the value was 3.2, this was significant. Nothing in her life had changed to account for this. Last time thyroid checked was Nov2020 and was normal. Treatment was received for adverse event (AE), thyroid medicines was increased. Patient visited doctor or other healthcare professional office/clinic visit due to AE. The outcome of the event was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Illness, Weight decreased
Clinical narrative: My blood pressure dropped down to 93 over 48; I lost almost 45 Lbs; I was terrible sick because of your vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a very sever reaction to it, patient spent the better part of 2 weeks not even knowing what day it was, patient lost almost 45 lbs and was almost put in the hospital because blood pressure dropped down to 93 over 48 and patient was terribly sick because of vaccine. Patient wished to god o would have never taken this vaccine. it almost killed patient and a month later patient was just now coming out of it. The outcome of events 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: Patient tested positive for Covid-19 on 18Apr2021 and tested positive again last Saturday (05Jun2021).Patient's second dose is due today; Patient tested positive for Covid-19 on 18Apr2021 and tested positive again last Saturday (05Jun2021).Patient's second dose is due today; This is a spontaneous report from a contactable pharmacist. A 40-years-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as first dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced patient tested positive for COVID-19 on 18Apr2021 and tested positive again last Saturday (05Jun2021). The patient second dose was due on the date of reporting. The pharmacist wanted to know if the patient in the pharmacy can receive the second dose of the Pfizer BioNTech COVID-19 Vaccine despite a history of COVID-19 infection. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 18Apr2021 and sars-cov-2 test: positive on 05Jun2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and covid-19 cannot be totally excluded
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: had a fever of 104 and it subsided at 2am but it is back at 102; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer reported for his daughter (patient). A 12-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration, on 09Jun2021, as 1ST dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 09Jun2021, patient had a fever of 104 (unit unspecified) and it subsided at 2am but it is back at 102(unit unspecified) on 10Jun2021. He wanted to report that and to make sure that he is doing the right thing by giving her Motrin. The outcome of the event was unknown.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Nasopharyngitis
Clinical narrative: Was due for his second dose today but woke up with a cold; He is sick; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program COVAX US support. A 62-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0175) via an unspecified route of administration in left arm on 20May2021 at 11:00 as 1st dose, single dose for COVID-19 immunization. Patient had no medical history. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that on 10Jun2021, Patient was sick and was due for his second dose today but woke up with a cold. Patient was taking COVID Vaccine because of COVID Prevention and his wife was bugging him to get it. Patient was not asking about timing but asking for assistance with rescheduling his appointment for his second vaccine dose. Patient had no other vaccines on the same day as the suspect product. Patient did not visit emergency room or physician office. The outcome of the events was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic fatigue syndrome, Investigation
Clinical narrative: severe CFS (Chronic Fatigue Syndrome); This is a spontaneous report received from a contactable other healthcare professional (patient). A 79 years-old non-pregnant female received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/lot number: Unknown) via an unspecified route of administration, in right arm on 24Feb2021 at 09:00 (at the age of 79-years-old) as a 2nd dose single dose for COVID-19 immunisation. Medical history included COPD (Chronic obstructive pulmonary disease), CFS (Chronic Fatigue Syndrome) and gluten intolerance (self-diagnosed for 35 years). Concomitant Medications received within 2 weeks of vaccination was just standard vitamins taken regularly. Past Drug history included sulfonamides (SULFA DRUGS) and one kind of benzylpenicillin (PENICILLINE). Patient had previously received the first dose of vaccine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID, prior vaccination. Patient and was doing a lot better, the first shot was fine but the second dose put her back into a severe CFS (Chronic Fatigue Syndrome) condition on 28Feb2021,. Still not much better by June. The adverse event results in visit to doctor or other healthcare professional office/clinic. A study of COVID -showed patient have no antibodies. Patient has not been tested for COVID, since the vaccination. The outcome of event was not resolved.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, Vaccination failure
Clinical narrative: On 03JUN2021 she came down with what seemed to be covid; Sars-Cov-2 infection; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number and Expiration date was unknown), via an unspecified route of administration on 24Apr2021 as 2ND DOSE, SINGLE DOSE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient also received the first dose of bnt162b2 (Solution for injection, Lot number and Expiration date: Unknown), via an unspecified route of admiration on an unspecified date as 1ST DOSE, SINGLE DOSE for Covid-19 immunization. It was reported that around 03Jun2021, she developed COVID-19 symptoms, which are now fading away. She explained she had a PCR (Polymerase Chain Reaction) COVID-19 test which came back negative. She said she really does not believe this result. She explained the false negative rate was not low with PCR (Polymerase Chain Reaction) tests and they are thus not reliable. She listed the following symptoms: fever, chills, diarrhea, and breathing difficulty. She specified she does not usually get fevers and never experienced chest and lung problems. She referred to her difficulty breathing as the chest and lung problems and repeated she never had such issues. She said she never even had a chest cold. She also explained that the HCPs, where she was located, are overwhelmed; and they do not assist further when you get a negative COVID-19 test. She added they refer you to the state department of health website if you have questions. She asked if an antibody test could be used to detect COVID-19. She also asked if Pfizer would not recommend her to pursue such test. The patient underwent lab tests and procedures which included Polymerase Chain Reaction test: negative on unspecified date in Jun2021. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Pneumonia, SARS-CoV-2 test
Clinical narrative: My stepfather on 31May2021 was diagnosed with Covid and right now has pneumonia; My stepfather on May 31 was diagnosed with Covid and right now has pneumonia; He had some trouble breathing; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer (Patients Stepchild) via medical information team. A 45-years-old male patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 23May2021 (at the age of 45-years-old) as 1st dose, single dose for covid-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing (it was a light condition. Arthritis was not getting worse he takes some medication). The patient's concomitant medications were not reported. The patient did not receive any other vaccines on the same day of vaccine vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient did not have any adverse events. On 31May2021, the reporter stated that patient was diagnosed with Covid and right now had pneumonia. Patient went to the hospital 2 days after that. Patient had to go back to the hospital a second time because he had some trouble breathing (unknown date in 2021). After the second time going to the hospital was when he was diagnosed with pneumonia. Patient was diagnosed with pneumonia a week ago (unknown date in May2021). Patient still had pneumonia, but it was much better with the medication. The reporter clarified that the patient had COVID-19 PCR testing and it took 2 days for the results to come back and patient went to the hospital he was referring to the Emergency Room for trouble breathing. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 31May2021. Therapeutic measures were taken for the results of the event pneumonia. The events covid-19 and pneumonia assessed as serious. The clinical outcome of the event pneumonia was recovering and outcome of the other events was unknown. The patient scheduled to received second dose of Pfizer COVID Vaccine on 13Jun2021.  Follow-up attempts are needed; information about lot/batch number can be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain
Clinical narrative: I started having pain in one side of my body; I find out I had a shingle that is it and very painful; This is a spontaneous report from a contactable consumer or other non-health professional (patient) reported for herself.   A female patient of an unspecified age received dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as 1st dose, single dose and received second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  She had adverse side effect from the Pfizer, she got the first dose and second dose and may be two weeks later or more may be after two week, she started had pain in one side of body for about a week and then later she found out had a shingle that is it and very painful. She wanted to know about any information about shingles as an adverse event to the Pfizer COVID-19 vaccine. She don't feel comfortable.She said that she had shingles after receiving the vaccine. The outcome of the events was resolving.  Information on the lot/batch number has been requested.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.  Follow-up (11Jun2021): This is a Follow-up spontaneous report from a contactable consumer (patient) reported for herself.   Information on the lot/batch number has been requested.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Sleep disorder, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: arm became hurt; swollen like a size of her palm under the area where she got the shot; redness and feeling hot; redness and feeling hot; sometimes irritable when sleeping; This is a spontaneous report from a contactable consumer (patient herself). An 89-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in arm on 09Jun2021 as 2nd dose, single dose (at the age of 89-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 19May2021 as 1st dose, single dose for COVID-19 immunization. Patient had no reaction on previous exposure to vaccine (first dose). Patient took the 2nd dose of the PFIZER COVID 19 vaccine on 09Jun2021. On the night, when she had the 2nd shot her arm became hurt, felt it was swollen like a size of her palm under the area where she got the shot, redness and feeling hot, sometimes irritable when sleeping. She wanted to know if these were the reported side effects of the vaccine.  The outcome of the events was unknown.   Follow-up attempts are possible. Further information is expected.