chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: NOT ADVERSE  but positive effect Broncial tubes opened up Breathing much improvedThank You; This is a spontaneous report from a contactable consumer, reporting for himself. A 75-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number en 6200) via an unspecified route of administration in left arm on 21Feb2021 11:00 at single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number en6208) via an unspecified route of administration in left arm on 14Mar2021 11:00 at single dose for COVID-19 immunisation. Relevant medical history included obesity and hypertension, the patient had no allergies. The patient was taking multiple other medications in two weeks (unspecified), but concomitant medications were not reported. The patient did not receive any other vaccine in four weeks and was not tested for COVID prior to vaccination. The patient had no adverse effects but positive effect, bronchial tubes opened up and breathing was much improved. Outcome of the event was unknown. The patient was not tested for COVID post vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Headache, Joint swelling
Clinical narrative: hands and feet swelling; headache; back starting hurting; This is a spontaneous report from a contactable consumer (patient's spouse)  A 62-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 10Mar2021 (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation.  Medical history included prostate cancer, surgery for prostate cancer about 4 months ago, tooth extraction on 09Mar2021. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, diphenhydramine hydrochloride (BENADRYL), amoxicillin. On 12Mar2021 the patient experienced hands and feet swelling, he started getting body aches and a really severe headache. All events were assessed as non -serious.  It was also informed that on 09Mar2021 he was at the dentist for a dental procedure and they give him amoxicillin. By Friday evening his hand was completely swollen, his legs were swollen a little bit and then his back starting hurting, had a headache so is that may be a combination of amoxicillin and the Pfizer shot (as reported). At the time of the reporting the patient was recovering from the events.    No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Pain, Pyrexia
Clinical narrative: fever; cough; aching; This is a spontaneous report from a contactable consumer (mother) behalf of patient. A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 15Mar2021 10:50 as single dose for COVID-19 immunisation. Medical history included bipolar disorder, this was diagnosed when patient was young, as a child; ADHD, this was diagnosed when patient was young, as a child; moderate mental retardation from 2015, this was diagnosed clinically after having tri-annual low IQ scores of 50; traumatic brain injury from 2019; PTSD from 2020; neck and back injuries from 2019. The patient had not any other recent vaccinations or started any new medications. On 16Mar2021, patient had a fever and a cough. The patient prior to had the onset of fever, he complained he was aching so gave him Motrin 200 mg and then he went to respite and when picked him up around 17:00, he complained again so gave him Tylenol 650 mg and around 20:30 patient temperature was 98 degrees Fahrenheit. The patient underwent lab tests and procedures which included body temperature: 100.7 fahrenheit in 2021, body temperature: 98 fahrenheit in 2021. Therapeutic measures were taken as a result of fever and aching with Tylenol 650 mg and Motrin 200 mg. The outcome of the event aching was unknown, cough was not resolved and fever was resolved on unknown date of 2021.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: reporting waking up every morning with nose bleeds on the right side/nose bleed/ it only gushes from her right nostril, only the right one; This is a spontaneous report from a contactable consumer (patient).  This 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not provided), via an unspecified route of administration, on 02Mar2021 at 11:30 (at the age of 57-year-old) at single dose for COVID-19 immunisation. Relevant medical history included Graves' disease from 2016 (5 years ago) and went in remission. The patient not had any other recent vaccinations or started any new medications. She said she was not on any medications, all she did take were supplements which she had been on the same ones for years. The patient was waking up every morning with nose bleeds on the right side. Also reported having her vaccine shot on the right side and asking was this normal. It really has just happened since she got the shot. She said she was not sure if there was a correlation, but she thought she would mention it. The patient had no treatment for the nosebleeds, she had stopped them when it happened. She said it was not a little nosebleed, and it only gushed from her right nostril, only the right one, and she got it to stop after a few minutes. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: muscle twitching, on her left cheek and between the jaw line area; This is a spontaneous report from a contactable consumer (patient).   A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported), age at vaccination of 63-years-old, as single dose, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced muscle twitching on left cheek and between the jaw line area non-serious) on an unspecified date almost two weeks after vaccine. Outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Diarrhoea, Fatigue
Clinical narrative: stomach pains; diarrhea; bloatedness; tiredness; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Feb2021 at 15:00 at single dose in left arm for COVID-19 immunisation at the age of 51-year-old. Medical history included Penicillin allergies. Concomitant medications included atorvastatin (LIPITOR), melatonin. On 03Mar2021 at 15:00, the patient experienced stomach pains, diarrhea, bloatedness, tiredness. They lasted for two weeks and the doctors said there was no way this could be coming from the vaccine. The patient was not treated for the events. The patient did not recover from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: feeling of congestion; difficulty breathing because of the congestion; fever of 99.4F; chills; She has experienced sweating the last two days; sleepy; She has lost her appetite; She feels like she has a head cold; she felt tired/exhausted; This is a spontaneous report from a contactable consumer (patient)  A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9269) on 10Mar2021 at 16:30  at single dose via an unspecified route of administration  on arm right  for COVID-19 immunization. Relevant medical history included ongoing high blood pressure. On Saturday (13Mar2021), patient felt tired, exhausted, sleepy and lost her appetite and she feels like she has a head cold . The next morning (14Mar2021), she felt like she had a cold, feeling of congestion, difficulty breathing because of the congestion, fever of 99.4F and chills. These symptoms persisted for the next 2 days. She took 2 Tylenols for her symptoms. She said that her fever comes and goes (as such). Patient was concerning if these adverse events are normal after taking the vaccine. She was also concerning because the symptoms happened a while after and not immediate. At the time of the reporting the patient had not yet recovered from reported events.   No Follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hyperhidrosis, Nasopharyngitis, Pyrexia, Somnolence
Clinical narrative: feeling of congestion; difficulty breathing because of the congestion; fever of 99.4F; chills; She has experienced sweating the last two days; sleepy; She has lost her appetite; She feels like she has a head cold; she felt tired/exhausted; This is a spontaneous report from a contactable consumer (patient)  A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9269) on 10Mar2021 at 16:30  at single dose via an unspecified route of administration  on arm right  for COVID-19 immunization. Relevant medical history included ongoing high blood pressure. On Saturday (13Mar2021), patient felt tired, exhausted, sleepy and lost her appetite and she feels like she has a head cold . The next morning (14Mar2021), she felt like she had a cold, feeling of congestion, difficulty breathing because of the congestion, fever of 99.4F and chills. These symptoms persisted for the next 2 days. She took 2 Tylenols for her symptoms. She said that her fever comes and goes (as such). Patient was concerning if these adverse events are normal after taking the vaccine. She was also concerning because the symptoms happened a while after and not immediate. At the time of the reporting the patient had not yet recovered from reported events.   No Follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Presyncope
Clinical narrative: almost passed out trying to get to the bathroom; I'm exhausted; no energy whatsoever; my joints ache; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on Mar2021 (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 was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. The patient stated that on 12Mar2021, "I had my first Pfizer shot yesterday and it really kicked my butt! I almost passed out trying to get to the bathroom. Very nervous about the second shot! I'm exhausted, no energy whatsoever, and my joints ache!" Treatment and outcome of the events were unknown. Events did not result in visit to the emergency room or physician's office. The patient had not been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: toothache; This is a spontaneous report from a contactable consumer (patient)  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. Patient got the first of the vaccine shot and was scheduled for the second shot on 20Mar2021. On 16Mar2021, patient had a toothache and he took 1 pill of amoxicillin for his toothache. His daughter told him that he could not take the vaccine now that he was taking amoxicillin. Caller wanted to know if that was true.The outcome of the event toothache was unknown.No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia
Clinical narrative: About 02:30 am on 17 Mar 2021, I began to experience chills as well as upper extremity joint and muscle pain. The events continued during the day. As of 19:51 hrs on 17 Mar, they resolved with the use; About 02:30 am on 17 Mar 2021, I began to experience chills as well as upper extremity joint and muscle pain. The events continued during the day. As of 19:51 hrs on 17 Mar, they resolved with the use; About 02:30 am on 17 Mar 2021, I began to experience chills as well as upper extremity joint and muscle pain. The events continued during the day. As of 19:51 hrs on 17 Mar, they resolved with the use; This is a spontaneous report from a contactable consumer (patient).  A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6199), via an unspecified route of administration, on 16Mar2021 at 10:45 AM (at the age of 47-year-old) at single dose for COVID-19 immunization, administered at clinic. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN5318), administered on 24Feb2021 at 10:45 AM (at the age of 47-year-old) at single dose for COVID-19 immunization. No relevant medical history was provided. Relevant concomitant medications included escitalopram, allopurinol, vitamin D NOS, and folic acid. About 02:30 am on 17Mar2021, he began to experience chills as well as upper extremity joint and muscle pain. The events continued during the day. As of 19:51 hrs on 17Mar2021, they resolved with the use of ibuprofen.   No follow-up attempts are needed. No further information is expected
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Headache
Clinical narrative: Blood pressure went from normal 135/65 to 180/100 within two hours; Headache; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Mar2021 15:30 (at the age of 57years) as unknown, single for Covid-19 immunization. Medical history included acid reflux after gallbladder removal, hypertension, and allergy to Strawberries; all from an unknown date and unknown if ongoing. Concomitant medications included lisinopril (LISINOPRIL) and omeprazole (OMEPRAZOLE), both taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced blood pressure went from normal 135/65 to 180/100 within two hours (as reported) and headache on 17Mar2021 23:00. The patient has not been tested for COVID-19 since the vaccination. It was unknown if the patient was treated for the events. The outcome of events was not recovered.  Information on the lot/ batch number has been requested.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache and exhaustion; Headache and exhaustion; This is a spontaneous report from a contactable consumer (patient)  This 26-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 13:30 (Batch/Lot Number: EL3248) as SINGLE DOSE for covid-19 immunisation.Age at vaccination:  The patient received the first dose of the same vaccine on 23Feb2021 on left arm Lot # EL3247. Medical history included , raw apricots allergy .The patient's concomitant medications were not reported.  The patient experienced headache and exhaustion on 17Mar2021 with outcome of recovering .Additional information : Prior to vaccination, the patient was not diagnosed with COVID-19Since the vaccination, the patient has not  been tested for COVID-19.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Diarrhoea
Clinical narrative: Diarrhea; Stomach pain; felt little weak; This is a spontaneous report from a contactable consumer, the patient. A 24-Year-old non-pregnant 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 17Mar2021 at 14:00 (at the age of 24-year-old), as a single dose for COVID-19 immunisation. The patient's medical history was none. The patient was not allergic to medication, food and other products. Concomitant medications included Vyvanse (MANUFACTURER UNKNOWN), lutera (MANUFACTURER UNKNOWN), melatonin 3mg supplement as needed (MANUFACTURER UNKNOWN). The patient had not received other vaccines within 4 weeks prior to COVID-19 vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since vaccination. On 17Mar2021 at 12:00, the patient experienced diarrhea shortly after receiving vaccine, stomach started hurting, stomach pains and felt little weak. The patient received no treatment for diarrhea, stomach started hurting, stomach pains and felt little weak. The clinical outcome of diarrhea, stomach pains and felt little weak was resolving.   Information about lot number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Back pain
Clinical narrative: Aches to upper back and hipsLeft axillary pain; Aches to upper back; Aches to upper back and hips; This is a spontaneous report from a contactable Nurse, the patient. A 52-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208), via an unspecified route of administration in the left arm on 15Mar2021 at 18:00 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no allergies to medications, food or other products. Prior to vaccination, the patient was diagnosed with COVID-19 on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced Aches to upper back and hips Left axillary pain 17Mar2021. The patient did not receive treatment for the reported events. The clinical outcome of the events Aches to upper back and hips Left axillary pain was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Diarrhoea, Dizziness, Headache
Clinical narrative: Diarrhea; Severe Headache; Dizziness; Some Blood In Urine; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6201), via an unspecified route of administration in the right arm on Mar2021 at 23:45 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19.Since the vaccination, patient had not been tested for COVID-19.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have any allergies to medications, food, or other products. On 06Mar2021, the patient experienced diarrhea, severe headache, dizziness, and some blood in the urine. The patient did not receive any treatment for the events. The clinical outcomes of the evente diarrhea, severe headache, dizziness, and some blood in urine were recovered.   No follow-up attempts are needed. No further information is expected
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Low grade fever 99.5; Muscle aches and pains all over body; Muscle aches and pains all over body; Injection site pain; This is a spontaneous report received from a contactable consumer (patient herself). A 45-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE, Solution for injection, Lot no: En6203) via unspecified route of administration on an as unknown, single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient medical history and concomitant drugs were not reported. On 18Mar2021, the patient experienced low grade fever 99.5, muscle ache, pain all over the body and vaccination site pain. The clinical outcome of low-grade fever 99.5, muscle ache, pain all over the body and vaccination site pain was unknown.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information which included Protect Confidentiality was checked for the reporter since reported for self, patient's detail contact information was added in Patient Information field, for Lab Data: only 99.5 was retained in result field; Low grade fever was captured in notes field, in consolidated narrative: Prior to vaccination, the patient was diagnosed with COVID-19 was updated to Prior to vaccination, the patient was not diagnosed with COVID 19 per source  Prior to vaccination, was the patient diagnosed with COVID-19 was No, in consolidated narrative: Since the vaccination, the patient had not been tested for COVID 19 was removed since not reported in source.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3247), via an unspecified route of administration in the left arm on 17Mar2021 (at the age of 36-years-old) as single dose for COVID-19 immunisation. The medical history includes RSD (Reflex sympathetic dystrophy). The patient is Allergic to soy, nuts (not extreme allergy). Concomitant medications were not reported. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the left arm on 17Mar2021, as a single dose for COVID-19 immunisation. On 17Mar2021. the patient experienced Pain in whole upper arm which received the shot. Feels like a rock or inflated balloon. The clinical outcome of the Pain in whole upper arm which Felt like a rock or inflated balloon was unknown.  No follow-up attempts are possible. No further information is expected.  Amendment (15Jun2021): This follow-up report is being submitted to amend previously reported information which includes: protect confidentiality checked since reporter is the patient self, for relevant med history#01 the verbatim were updated, for historical vaccine with BNT162B2 1st dose: age/units captured as 36 years per vaccination date and DOB, "known_allergies: soy, nuts (not extreme allergy)" was added as relevant med history.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Palpitations
Clinical narrative: Heart palpitations worsening to the point where they are making me cough occasionally; cough occasionally; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via unspecified route of administration in right arm on 06Mar2021 at 10:15 hours (at the age of 62-years) as a single dose for COVID-19 immunisation. Medical history included premature ventricular contractions (PVCs). It was reported as heart PVCs much lighter than what she had now. Concomitant medications included ESTRING and TYLENOL PM. The patient received these medications within 2 weeks of vaccination. The patient was allergic to morphine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Mar2021 at 08:00 hours, the patient had heart palpitations worsening to the point where they were making her cough occasionally. The clinical outcome of the events palpitations aggravated and cough was not resolved.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm; Moderate Headache; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 17Mar2021 at 09:45 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history included Meniere's disease, Hashimoto's disease, and vitiligo. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included calcium (MANUFACTURER UNKNOWN), levothyroxine sodium (LEVOXYL), melatonin (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates and unknown if ongoing. The patient previously 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 24Feb2021 at 16:45 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. The patient previously took terconazole (TERAZOL) for an unknown indication and experienced fever. Since the vaccination, the patient had not tested for COVID-19. On 17Mar2021 at 20:45, the patient experienced moderate headache and sore arm. The patient did not receive treatment for the reported events. The clinical outcome of the events moderate headache and sore arm were recovered on an unspecified date in Mar2021.  Information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pain, Pyrexia
Clinical narrative: Nausea; Vomiting; Cold shakes; Entire body aches; 101.6 temp; This is a spontaneous report received from a contactable consumer, the patient. A 44-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6208) via an unspecified route of administration in left arm on 17Mar2021 at 09:00 am (age at vaccination 44-year-old), as single dose for COVID-19 vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: En 6202) via an unspecified route of administration in left arm on 20210225 at 11:30 am as single dose for COVID-19 vaccination. Medical history included high cholesterol and penicillin allergy. Patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, was not tested for COVID-19. The patient experienced Nausea, vomiting, cold shakes, entire body aches and temperature of 101.6 (units unspecified) on 17Mar2017 at 22:00. The patient did not receive any treatment for the reporting events. The clinical outcome of nausea, vomiting, chills, general body pain and high temperature was not resolved.   No follow-up attempts are possible. No further information is expected
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea; Vomiting; Cold shakes; Entire body aches; 101.6 temp; This is a spontaneous report received from a contactable consumer, the patient. A 44-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6208) via an unspecified route of administration in left arm on 17Mar2021 at 09:00 am (age at vaccination 44-year-old), as single dose for COVID-19 vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: En 6202) via an unspecified route of administration in left arm on 20210225 at 11:30 am as single dose for COVID-19 vaccination. Medical history included high cholesterol and penicillin allergy. Patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, was not tested for COVID-19. The patient experienced Nausea, vomiting, cold shakes, entire body aches and temperature of 101.6 (units unspecified) on 17Mar2017 at 22:00. The patient did not receive any treatment for the reporting events. The clinical outcome of nausea, vomiting, chills, general body pain and high temperature was not resolved.   No follow-up attempts are possible. No further information is expected
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site pain
Clinical narrative: Sore arm where injection was administered; Slight bruising at injection site; This is a spontaneous report from a contactable consumer. A 33-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 17Mar2021 at 09:00(at the age of 33 years old) as a single dose for COVID-19 immunisation. The patients Medical history was not reported. Concomitant medications included Escitolopram (MANUFACTURER UNKNOWN), doxycycline (MANUFACTURER UNKNOWN) and Omeprazol (MANUFACTURER UNKNOWN), all for an unknown indication from an unknown date. The Patient did not have any allergies to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccination. Prior to vaccination, patient was not diagnosed with Covid-19. The Patient had not tested positive for COVID-19 since the vaccination. The patient experienced sore arm where injection was administered and slight bruising at injection sight on 17Mar2021 at 10:30. The patient did not receive treatment for the reported event. The clinical outcome of the vaccination site pain and vaccination site bruising was recovering.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Peripheral swelling, Vaccination site swelling
Clinical narrative: Swollen underarm/lymph node area; Eighteen hours after shot slightly swollen injection site; Extreme tiredness.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the right arm on 16Mar2021 at 9.30AM (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient medical history was not provided. Concomitant medications included Ativan (MANUFACTURER UNKNOWN) on unspecified date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via an unspecified route of administration in left arm on 23Feb2021 at 03.45PM for COVID-19 immunisation. The patient had not tested positive for COVID-19. The patient experienced extreme tiredness on 16Mar2021 at 03:30 PM, slightly swollen injection site and slightly swollen underarm on 17Mar2021 at 03:30 AM and extremely swollen underarm/lymph node area on 17Mar2021 at 07:30 PM. The patient had not received any treatment for the events. Clinical outcomes of the event extreme tiredness, swollen injection site and swollen underarm were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Fatigue and headache; Fatigue and headache; This is a spontaneous report received from a contactable consumer (patient).  A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 14:30 (Batch/Lot Number: EN6203) age at vaccination of 51-years-old, as single dose, for covid-19 immunisation.  The patient medical history was not reported. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, administered in Arm Left on 16Feb2021 14:30 (Batch/Lot Number: EL3247), for covid-19 immunisation. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue and headache on 17Mar2021 14:30. No treatment was given for the events. The patient recovered from the events on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hangover, Headache, Influenza like illness, Musculoskeletal stiffness
Clinical narrative: Overall mild flu like symptoms; grogginess / tiredness.; grogginess / tiredness.; Mild headache; Overall 'hung over' like feeling; Later that evening, mild injection site pain and stiffness.; Later that evening, mild injection site pain and stiffness.; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 17Mar2021 10:00 (Lot Number: EL3248) as single dose (at the age of 39-year-old) for covid-19 immunisation. Medical history was reported as none. Patient had not known allergies. There were no concomitant medications taken within two weeks of vaccination. First dose of bnt162b2 (BNT162B2) was administered on 24Feb2021 03:30 PM in Left arm for COVID-19 immunization (at the age of 39-year-old), Lot Number: EL3248. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Patient stated that he received his second (2 nd) dose at 10am EDT. No initial adverse event (ae). Later that evening, on 17Mar2021 at 10:00 PM, mild injection site pain and stiffness. The next morning (at the time he was writing this) more significant injection site pain. On 18Mar2021, overall mild flu like symptoms; grogginess / tiredness. Mild headache. Overall 'hung over' like feeling. Patient was a Pfizer employee and received both doses at a Pfizer site as part of the employee vaccination program. Patient was not treated for the events. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. Patient was recovering from the events. No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site pain
Clinical narrative: Overall mild flu like symptoms; grogginess / tiredness.; grogginess / tiredness.; Mild headache; Overall 'hung over' like feeling; Later that evening, mild injection site pain and stiffness.; Later that evening, mild injection site pain and stiffness.; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 17Mar2021 10:00 (Lot Number: EL3248) as single dose (at the age of 39-year-old) for covid-19 immunisation. Medical history was reported as none. Patient had not known allergies. There were no concomitant medications taken within two weeks of vaccination. First dose of bnt162b2 (BNT162B2) was administered on 24Feb2021 03:30 PM in Left arm for COVID-19 immunization (at the age of 39-year-old), Lot Number: EL3248. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Patient stated that he received his second (2 nd) dose at 10am EDT. No initial adverse event (ae). Later that evening, on 17Mar2021 at 10:00 PM, mild injection site pain and stiffness. The next morning (at the time he was writing this) more significant injection site pain. On 18Mar2021, overall mild flu like symptoms; grogginess / tiredness. Mild headache. Overall 'hung over' like feeling. Patient was a Pfizer employee and received both doses at a Pfizer site as part of the employee vaccination program. Patient was not treated for the events. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. Patient was recovering from the events. No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: Armpit pain; This is a spontaneous report from a contactable consumer, the patient. A 29-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the right arm on 15Mar2021 at 18:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not provided. The past drug history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the right arm on 20Feb2021 at 14:00 as a single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 16Mar2021, the patient experienced armpit pain. The patient did not receive treatment for the armpit pain. The clinical outcome of the armpit pain was unknown. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive to the COVID-19 rapid test; This is a spontaneous report from a contactable consumer or other non-hcp (patient).   A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6204) via an unspecified route of administration on 04Mar2021 as single dose for COVID-19 immunization. The patient medical history included exposure to Sars cov 2. The concomitant medications were not reported. The patient experienced feeling mild symptoms more like a cold; headache; he was congested and experienced little body ache on an unspecified date; son came over on March 10th / he went on Thursday to get a test and received positive covid-19 test result; tested positive to the covid-19 rapid test. The patient underwent lab tests and procedures which included SARS-COV-2 test positive: positive on 15Mar2021. The seriousness of the events was reported as non-serious. The clinical outcome of the events was unknown.  Description of Product Complaint: Consumer stated, So, I had my first Pfizer vaccine (COVID vaccine) on 06Mar (not clarified). So, two Saturdays ago and last Wednesday, the 10th (not clarified) my son came over at our house and we ate in the same room and we did not have our masks on while we were eating. So, the next day, he did not feel well and went and got a COVID test and Friday night he got the results that he has COVID (further clarification unknown). So, Friday the 12th (not clarified), that day, I worked at home now and I was tired, and I took a nap and that really does not happen very often. So, I wondered, I know I did not feel good but (sentence incomplete). So anyhow, he got COVID that night that and he was positive, and my husband and I decided to sleep in different rooms until we get a test. Had a really bad snowstorm that weekend, so all testing sites were closed, and we were able to get on Monday. My husband was negative, but I was positive, but my symptoms are very mild, it is like a slight headache but nothing bad. It feels like a normal head cold. I am congested, little body ache and tired. But today, I feel a lot better than the last couple days. So, very mild symptoms but I have a couple of questions about my husband as he was scheduled for his first vaccine this Friday, but he went ahead and cancelled because of that. So, I guess I want to understand when he can get vaccinated if he does not get COVID and then since I have it, my second vaccine is supposed to be on 26th, so that is a week from this Friday. So, I wondered if I can still do that.  Expiration Date has been requested. Further information needed and further information expected.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Insomnia, Paraesthesia
Clinical narrative: sleeplessness; tingling burning in arms at night; tingling burning in arms at night.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 6205) via an unspecified route of administration in the left arm on 27Feb2021 at 12:00 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Patient Medical history include COVID-19 infection around mid Feb. The patient had not been tested for COVID-19 since the vaccination. The patients concomitant medications included pantaprozole (MANUFACTURER UNKNOWN), rosuvastatin (CRESTOR), simethicone (PHAZYME) and finasteride (MANUFACTURER UNKNOWN) all for unknown indications from unknown dates. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 14Mar2021, at 03:00 after 2 weeks of vaccination patient experienced sleeplessness and tingling burning in arms. The patient did not receive any treatment for sleeplessness and tingling burning in arms. The clinical outcome of sleeplessness and tingling burning in arms was not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle strain, Paraesthesia, Urine abnormality
Clinical narrative: horriblemuscle pull from hip down.; PeriodicNumbness; tingling in right footand calf.; Very cloudy urine at firsturination of the day.; This is a spontaneous report received from a contactable consumer, the patient. A 47-year-old-male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534,) via an unspecified route of administration in the left arm on 17Mar2021 at 12:30 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203,) via an unspecified route of administration into left arm on 24Feb2021 at 12:30 for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient did not receive any medications within 2 weeks of vaccination. Prior to vaccination the patient had not tested positive for COVID-19. No concomitant medications were reported. Since the vaccination, the patient had not diagnosed with COVID-19. On 17Mar2021 at 14:30, the patient had experienced horrible muscle pull in right leg from hip, periodic numbness and tingling in right foot and calf, very cloudy urine at first day of vaccination. The patient did not receive any treatment for the reported events. The clinical outcome of the events horrible muscle pull from hip down, periodic numbness, cloudy urine, tingling in right foot and calf was not resolved. No follow-up attempts are possible, no further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Diarrhoea, Dizziness, Eye pain
Clinical narrative: Nausea; Diarrhea; vaccination site redness/swelling; Muscle aches; Pain; Jaw tightness; Eye pain; Sinus pain; Congestion; Chest tightness; runny eyes; tight shoulder/neck; Fever; injection site redness/swelling,; jaw tightness and pain; Headache; Dizziness; Tremors; This is a spontaneous report received from a contactable healthcare professional, the patient. A 41-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in the left arm on 14March2021 at 14:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension, overweight and penicillin allergy eliminated in 2019. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), desloratadine (MANUFACTURER UNKNOWN), all for unknown indication from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 21Feb2021 at 17:30 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 15Mar2021 at 02:30, 12 hours post through 36 hours post, the patient experienced severe headache, dizziness, tremors, surges felt head to toe or vibrations and fever for 2 hours up to 102-102.8. On 15Mar2021 at 18:15, 28 hours post dose, the patient experienced nausea, diarrhea, injection site redness/swelling, pain and muscle aches, jaw tightness and pain, eye pain, sinus pain, congestion, dizziness, chest tightness, runny eyes and tight shoulder or neck. The patient received treatment for the adverse events and was treated with acetaminophen (MANUFACTURER UNKNOWN). The clinical outcome of the event fever was recovered on 15Mar2021 and headache, dizziness, tremor, nausea, diarrhea, vaccination site swelling, vaccination site erythema, pain, muscle aches, jaw tightness, jaw pain, eye pain, sinus pain, sinus congestion, chest tightness, watery eyes, neck tightness was recovering.   No follow-up attempts are needed. No further information is expected.