chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: a little bit unbalanced; she noticed constant hypertension, has not been able to control it/high blood pressure; nausea; tiredness; anxiety attacks; she woke up feeling unwell; weak; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021354605.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Mar2021 15:30 (Lot number: EN6208) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hypertension" (ongoing); "cancer" (unspecified if ongoing). Concomitant medication(s) included: ENALAPRIL taken for hypertension (ongoing). The following information was reported: MALAISE (non-serious) with onset 24Mar2021, outcome "unknown", described as "she woke up feeling unwell"; BLOOD PRESSURE INADEQUATELY CONTROLLED (non-serious) with onset 25Mar2021, outcome "unknown", described as "she noticed constant hypertension, has not been able to control it/high blood pressure"; NAUSEA (non-serious) with onset 25Mar2021, outcome "unknown", described as "nausea"; FATIGUE (non-serious) with onset 25Mar2021, outcome "unknown", described as "tiredness"; ANXIETY (non-serious) with onset 25Mar2021, outcome "unknown", described as "anxiety attacks"; ASTHENIA (non-serious) with onset Mar2021, outcome "unknown", described as "weak"; BALANCE DISORDER (non-serious) with onset 31Mar2021, outcome "unknown", described as "a little bit unbalanced". Therapeutic measures were taken as a result of hypertension.  Additional information: There were no additional vaccines administered on the same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated she received Pfizer Vaccine was on Tuesday and her blood pressure increased, had constant hypertension, and has not been able to control it, on Thursday (25Mar2021) at night and then yesterday at night. So whenever the blood pressure went up she took her pill of Enalapril and whenever she takes the Enalapril the blood pressure goes down and after that the feeling of anxiety came and she was too weak and was tired; stated the Enalapril 10mg she takes and would not take it this way if she weren't feeling like this but has taken it once per day and since that feeling started she takes it twice per day and three times per day. Patient also stated today she was feeling better and her blood pressure went up last night and she had anxiety and then took her blood pressure pill Enalapril and today she was tired and a little bit unbalanced. Events did not result to emergency room and physician office visit.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose, Dizziness, Feeling abnormal, Gait disturbance
Clinical narrative: got a little light headed; wobbly; had a strange feeling of weakness; had a strange feeling of weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 09:00 (Lot number: ENG205) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (dose 1, single, lot number: EL9266, administered in Left arm), administration date: 07Mar2021, when the patient was 74 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 29Mar2021 14:00, outcome "not recovered", described as "got a little light headed"; GAIT DISTURBANCE (non-serious) with onset 29Mar2021 14:00, outcome "not recovered", described as "wobbly"; FEELING ABNORMAL (non-serious), ASTHENIA (non-serious) all with onset 29Mar2021 14:00, outcome "not recovered" and all described as "had a strange feeling of weakness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The vaccine was administered in an outside clinic. The patient thought she was being hypoglycemic since she has diabetes but she checked her sugar and it read 146 (no unit provided). The patient did not want to feel panicky but the reaction hasn't gone away and kept on reoccurring. The patient wanted to know if this was effect of the vaccine. Events did not result to emergency room or physician office visit but she was planning to go to her doctor.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Glycosylated haemoglobin, Magnetic resonance imaging, Vision blurred, Visual impairment
Clinical narrative: floaters in eye; seeing spots of light; vision is a little cloudy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 12Mar2021 (Lot number: EN6206) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High & low blood pressure (fluctuating)", start date: 2015 (ongoing); "sinus issues", start date: 2011 (ongoing), notes: had sinus issues due to sinus polyp surgery; "sinus polyps" (not ongoing); "sinus polyp surgery", start date: 2011, stop date: 2011; "during polyp surgery, physician went up too far and put a hole in the brain", start date: 2011, stop date: 2011, notes: ended up with meningitis and almost died; in a coma; "meningitis" (unspecified if ongoing), notes: has fluid leaking from the brain; "almost died" (not ongoing); "coma" (not ongoing); "Weight loss" (not ongoing), notes: started taking Metoprolol after gaining weight back; "headaches" (ongoing), notes: due to sinus issues; "leg and arms ache" (ongoing), notes: prior to vaccination; "body aches" (ongoing), notes: prior to vaccination. Family history included: "has floaters in vision before" (not ongoing), notes: prior to vaccination; (patient's sister also sees floaters because of diabetes). Concomitant medication(s) included: AMLODIPINE taken for blood pressure fluctuation (ongoing); BENADRYL taken for sinus disorder (ongoing); METOPROLOL; ACETAMINOPHEN taken for headache, pain (ongoing). The following information was reported: VITREOUS FLOATERS (non-serious) with onset Mar2021, outcome "recovering", described as "floaters in eye"; VISUAL IMPAIRMENT (non-serious) with onset Mar2021, outcome "not recovered", described as "seeing spots of light"; VISION BLURRED (non-serious) with onset Mar2021, outcome "not recovered", described as "vision is a little cloudy". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Time of vaccination was 9 something in the morning (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported that she has oxycodone for ongoing medical history of pain, but needs to be in really severe pain before taking it; still has not taken any. Patient also reported that she has been going online and looking up her symptoms and found something that stated it was possibly a detached retina, but she thought that the floaters and spots of light in her eyes were not due to a detached retina. She was scheduled to get the second dose on 02Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vitreous floaters
Clinical narrative: floaters in eye; seeing spots of light; vision is a little cloudy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 12Mar2021 (Lot number: EN6206) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High & low blood pressure (fluctuating)", start date: 2015 (ongoing); "sinus issues", start date: 2011 (ongoing), notes: had sinus issues due to sinus polyp surgery; "sinus polyps" (not ongoing); "sinus polyp surgery", start date: 2011, stop date: 2011; "during polyp surgery, physician went up too far and put a hole in the brain", start date: 2011, stop date: 2011, notes: ended up with meningitis and almost died; in a coma; "meningitis" (unspecified if ongoing), notes: has fluid leaking from the brain; "almost died" (not ongoing); "coma" (not ongoing); "Weight loss" (not ongoing), notes: started taking Metoprolol after gaining weight back; "headaches" (ongoing), notes: due to sinus issues; "leg and arms ache" (ongoing), notes: prior to vaccination; "body aches" (ongoing), notes: prior to vaccination. Family history included: "has floaters in vision before" (not ongoing), notes: prior to vaccination; (patient's sister also sees floaters because of diabetes). Concomitant medication(s) included: AMLODIPINE taken for blood pressure fluctuation (ongoing); BENADRYL taken for sinus disorder (ongoing); METOPROLOL; ACETAMINOPHEN taken for headache, pain (ongoing). The following information was reported: VITREOUS FLOATERS (non-serious) with onset Mar2021, outcome "recovering", described as "floaters in eye"; VISUAL IMPAIRMENT (non-serious) with onset Mar2021, outcome "not recovered", described as "seeing spots of light"; VISION BLURRED (non-serious) with onset Mar2021, outcome "not recovered", described as "vision is a little cloudy". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Time of vaccination was 9 something in the morning (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported that she has oxycodone for ongoing medical history of pain, but needs to be in really severe pain before taking it; still has not taken any. Patient also reported that she has been going online and looking up her symptoms and found something that stated it was possibly a detached retina, but she thought that the floaters and spots of light in her eyes were not due to a detached retina. She was scheduled to get the second dose on 02Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Feeling abnormal, Nausea
Clinical narrative: pain in his eye sockets that is ongoing; nausea; feeling yucky for a few days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 23Mar2021 13:00 (Lot number: EN6208) at the age of 70 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: EYE PAIN (non-serious) with onset 23Mar2021, outcome "recovering", described as "pain in his eye sockets that is ongoing"; NAUSEA (non-serious) with onset Mar2021, outcome "recovered" (26Mar2021), described as "nausea"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "feeling yucky for a few days". Additional information: The patient had no prior vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypersensitivity, Pain in extremity
Clinical narrative: allergic reaction; her arm was hurting; she felt very dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 11Feb2021 (Batch/Lot number: unknown) at the age of 73 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 11Feb2021, outcome "unknown", described as "she felt very dizzy"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm was hurting". Additional information: The patient and her husband received the first dose of the Pfizer Covid 19 vaccine on 11Feb2021. She felt very dizzy. She stated when they received the call for the second dose, she explained all this and was told not to get the second dose since they experienced an allergic reaction and to call to report it. It was also reported that her arm was hurting when given the vaccine. Patient was querying if they can be provided a card or letter explaining or saying they were allergic and can't get the second one so they can travel to another country.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021243669 Same reporter and product; similar events; different patient
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Light headache; Feel tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 15:00 (Lot number: EN6201) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Light headache"; FATIGUE (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Feel tired". Therapeutic measures were not taken as a result of headache, fatigue.  Additional Information: Patient reported that the tiredness and headache began Saturday 27Mar2021, for which he has done no treatment. Since then, patient said it has gotten worse. He would like to know if there was anything he could take or do to relieve his side effect symptoms.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Mobility decreased, Paraesthesia, Swelling, Vaccination site hypoaesthesia
Clinical narrative: hardly get out of bed; numbness on left arm; sharp lower back pain; pain is in the swell of her back and does not go down into legs but goes up to right side of body; feel her arm tingling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 24Mar2021 (Lot number: ER2613) at the age of 53 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Flu shot, administration date: 2020, reaction(s): "Soreness in arm". The following information was reported: VACCINATION SITE HYPOAESTHESIA (non-serious) with onset 26Mar2021, outcome "recovering", described as "numbness on left arm"; BACK PAIN (non-serious) with onset 26Mar2021, outcome "not recovered", described as "sharp lower back pain"; SWELLING (non-serious) with onset 26Mar2021, outcome "not recovered", described as "pain is in the swell of her back and does not go down into legs but goes up to right side of body"; MOBILITY DECREASED (non-serious) with onset 27Mar2021, outcome "unknown", described as "hardly get out of bed"; PARAESTHESIA (non-serious) with onset Mar2021, outcome "unknown", described as "feel her arm tingling". Therapeutic measures were taken as a result of vaccination site hypoaesthesia, back pain, swelling.  Additional information: The patient takes unspecified vitamins. The vaccine was given between 11:30 - 12:00. The event numbness on left arm occurred between 09:00 - 09:30 while the event lower back pain between 18:00 - 18:30. The events did not result to ER or physician office visit. The patient had not received any other vaccines within 4 weeks prior vaccination. The patient had no additional vaccines administered on same date of BNT162B2. The patient took two TYLENOL EXTRA STRENGTH 500mg, used heating pads, and had shower with warm water as treatment for the events.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Feeling abnormal, Muscle discomfort, Myalgia
Clinical narrative: muscle issues; feeling a lot of different sensations; pains in her back and stomach; pains in her back and stomach; soreness with my muscles; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 10Mar2021 (Lot number: EN6198) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: MUSCLE DISCOMFORT (non-serious), outcome "unknown", described as "muscle issues"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feeling a lot of different sensations"; MYALGIA (non-serious) with onset 10Mar2021, outcome "not recovered", described as "soreness with my muscles"; BACK PAIN (non-serious), ABDOMINAL PAIN UPPER (non-serious), outcome "unknown" and all described as "pains in her back and stomach". Additional information: The patient received the vaccine via left shoulder (as reported). The patient's concomitant medication (not specified) was reported for blood pressure medicine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Inappropriate schedule of product administration
Clinical narrative: received the first dose of the vaccine on 05Feb2021 and the second dose on 27Mar2021/ 50 days in between 1st and 2nd; slight chills; This is a spontaneous report received from a contactable consumer from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 27Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (dose 1, Batch/Lot number: unknown), administration date: 05Feb2021, for COVID-19 immunisation, reactions: "blood pressure high", "heart rate high", "rash", "shingles", "lung infection". The following information was reported: CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "slight chills"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 27Mar2021, outcome "unknown", described as "received the first dose of the vaccine on 05Feb2021 and the second dose on 27Mar2021/ 50 days in between 1st and 2nd".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Arm hurt (but could raise arm above head for a day); Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 23Mar2021 10:00 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Mar2021, outcome "recovered" (2021), described as "Arm hurt (but could raise arm above head for a day)"; FATIGUE (non-serious) with onset 23Mar2021, outcome "recovered" (2021), described as "Tired". Therapeutic measures were not taken as a result of pain in extremity, fatigue. Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and was unknown if the patient has been tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Head discomfort, Pain
Clinical narrative: Tired; body aches; pressure in the head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 20Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Cancer in remission" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: FATIGUE (non-serious) with onset 29Mar2021, outcome "unknown", described as "Tired"; PAIN (non-serious) with onset 29Mar2021, outcome "unknown", described as "body aches"; HEAD DISCOMFORT (non-serious) with onset 29Mar2021, outcome "unknown", described as "pressure in the head". It was unknown if therapeutic measures were taken as a result of fatigue, pain, head discomfort.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Faeces hard, Fatigue, Feeling abnormal
Clinical narrative: She had soreness a little bit; she got sick; she felt crappy; tired; Today her stool is harder and not as liquidy; diarrhea; she developed diarrhea with the continuing headache; dizziness/dizzy; nausea/nauseous; headache; didn't feel well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 28Mar2021, outcome "unknown", described as "dizziness/dizzy"; NAUSEA (non-serious) with onset 28Mar2021, outcome "unknown", described as "nausea/nauseous"; HEADACHE (non-serious) with onset 28Mar2021, outcome "unknown", described as "headache"; MALAISE (non-serious) with onset 28Mar2021, outcome "unknown", described as "didn't feel well"; FAECES HARD (non-serious), outcome "unknown", described as "Today her stool is harder and not as liquidy"; DIARRHOEA (non-serious) with onset 29Mar2021, outcome "unknown", described as "diarrhea"; HEADACHE (non-serious) with onset 29Mar2021, outcome "unknown", described as "she developed diarrhea with the continuing headache"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "She had soreness a little bit"; ILLNESS (non-serious), outcome "unknown", described as "she got sick"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she felt crappy"; FATIGUE (non-serious), outcome "unknown", described as "tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Malaise, Nausea, Pain in extremity
Clinical narrative: She had soreness a little bit; she got sick; she felt crappy; tired; Today her stool is harder and not as liquidy; diarrhea; she developed diarrhea with the continuing headache; dizziness/dizzy; nausea/nauseous; headache; didn't feel well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 28Mar2021, outcome "unknown", described as "dizziness/dizzy"; NAUSEA (non-serious) with onset 28Mar2021, outcome "unknown", described as "nausea/nauseous"; HEADACHE (non-serious) with onset 28Mar2021, outcome "unknown", described as "headache"; MALAISE (non-serious) with onset 28Mar2021, outcome "unknown", described as "didn't feel well"; FAECES HARD (non-serious), outcome "unknown", described as "Today her stool is harder and not as liquidy"; DIARRHOEA (non-serious) with onset 29Mar2021, outcome "unknown", described as "diarrhea"; HEADACHE (non-serious) with onset 29Mar2021, outcome "unknown", described as "she developed diarrhea with the continuing headache"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "She had soreness a little bit"; ILLNESS (non-serious), outcome "unknown", described as "she got sick"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she felt crappy"; FATIGUE (non-serious), outcome "unknown", described as "tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal mass, Limb mass
Clinical narrative: he developed lumps into his abdomen and left leg; he developed lumps into his abdomen and left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administration date 05Feb2021 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunisation. The following information was reported: ABDOMINAL MASS (non-serious), LIMB MASS (non-serious) all with onset Mar2021, outcome "not recovered" and all described as "he developed lumps into his abdomen and left leg". Therapeutic measures were not taken as a result of abdominal mass, limb mass.  Additional information: 3 weeks ago patient developed lumps into his abdomen and left leg and asking for recommendations on what to do.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate, Heart rate increased, Malaise
Clinical narrative: Pain in my left arm where I had received vaccination; Headache 3-4 hours after receiving the shot; Tiredness - I feel like I need to rest and sleep; Reluctant to do any physical activities; I feel-like that my heart rate increases; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 29Mar2021 11:00 (Lot number: EP6955) at the age of 36 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (Dose 1, administration time: 11:15, location: right arm, lot number: EL3247), administration date: 08Mar2021, for COVID-19 immunisation, reaction(s): "Pain in my left arm where I had received vaccination". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 29Mar2021 15:00, outcome "recovering", described as "Pain in my left arm where I had received vaccination"; HEADACHE (non-serious) with onset 29Mar2021 15:00, outcome "recovered" (Mar2021), described as "Headache 3-4 hours after receiving the shot"; FATIGUE (non-serious) with onset 29Mar2021 15:00, outcome "recovering", described as "Tiredness - I feel like I need to rest and sleep"; MALAISE (non-serious) with onset 29Mar2021 15:00, outcome "recovering", described as "Reluctant to do any physical activities"; HEART RATE INCREASED (non-serious) with onset 29Mar2021 15:00, outcome "recovering", described as "I feel-like that my heart rate increases". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, fatigue, malaise, heart rate increased. Therapeutic measures were taken as a result of headache.  Additional information: The patient had no known allergies. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient did not receive other vaccines in 4 weeks.  The patient received Tylenol 500 mg 2x as treatment for headache.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in my left arm where I had received vaccination; Headache 3-4 hours after receiving the shot; Tiredness - I feel like I need to rest and sleep; Reluctant to do any physical activities; I feel-like that my heart rate increases; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 29Mar2021 11:00 (Lot number: EP6955) at the age of 36 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (Dose 1, administration time: 11:15, location: right arm, lot number: EL3247), administration date: 08Mar2021, for COVID-19 immunisation, reaction(s): "Pain in my left arm where I had received vaccination". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 29Mar2021 15:00, outcome "recovering", described as "Pain in my left arm where I had received vaccination"; HEADACHE (non-serious) with onset 29Mar2021 15:00, outcome "recovered" (Mar2021), described as "Headache 3-4 hours after receiving the shot"; FATIGUE (non-serious) with onset 29Mar2021 15:00, outcome "recovering", described as "Tiredness - I feel like I need to rest and sleep"; MALAISE (non-serious) with onset 29Mar2021 15:00, outcome "recovering", described as "Reluctant to do any physical activities"; HEART RATE INCREASED (non-serious) with onset 29Mar2021 15:00, outcome "recovering", described as "I feel-like that my heart rate increases". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, fatigue, malaise, heart rate increased. Therapeutic measures were taken as a result of headache.  Additional information: The patient had no known allergies. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient did not receive other vaccines in 4 weeks.  The patient received Tylenol 500 mg 2x as treatment for headache.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Feeling abnormal, Muscle spasms
Clinical narrative: She said "maybe they gave me an expired dose" in passing.; she woke up with left leg cramping that was so bad/cramping in her left foot and lower leg and describes it as a "sharp shooting sensation".; 'a sharp, shooting sensation in her left foot and bottom part of her left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 67-years-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 10:00 (Lot number: EN6207) at the age of 67 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "She said "maybe they gave me an expired dose" in passing."; MUSCLE SPASMS (non-serious) with onset 25Mar2021 01:00, outcome "recovering", described as "she woke up with left leg cramping that was so bad/cramping in her left foot and lower leg and describes it as a "sharp shooting sensation"."; FEELING ABNORMAL (non-serious) with onset 25Mar2021 01:00, outcome "recovering", described as "'a sharp, shooting sensation in her left foot and bottom part of her left leg". Therapeutic measures were taken as a result of muscle spasms, feeling abnormal.  Additional Information: Reporter said that she had her first PFIZER COVID-19 Vaccine on 24Mar2021 at 10:00AM. She said she was a little concerned about getting the second COVID-19 injection because that night at 1:00AM (25Mar2021), she woke up with left leg cramping that was so bad, and a sharp, shooting sensation in her left foot and bottom part of her left leg. She said the next day (26Mar2021), at 10:00AM she had the same thing happen again, but the it was not as intense as the first time. She said for 48 hours after receiving the COVID-19 Vaccine, she had experienced the left leg cramping and sharp, shooting sensation in her left foot, and bottom part of her left leg, and on Saturday (27Mar2021), she had a real short episode. She said she hadn't had any more episodes since Saturday, and hopefully wouldn't have anymore. She said the episodes had been getting less intense. She had no prior Vaccinations within 4 weeks. She had no medical History (including any illness at time of vaccination). No relevant tests were done.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bruxism, Pain, Stomatitis, Toothache
Clinical narrative: acute stomatitis reaction; pain; her teeth hurts; felt like it was grinding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program . The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: STOMATITIS (non-serious), outcome "unknown", described as "acute stomatitis reaction"; PAIN (non-serious), outcome "unknown", described as "pain"; TOOTHACHE (non-serious), outcome "unknown", described as "her teeth hurts"; BRUXISM (non-serious), outcome "unknown", described as "felt like it was grinding". Therapeutic measures were taken as a result of pain. Additional information: Clinical course: Two weeks after receiving the Pfizer vaccine, the patient was having an acute stomatitis reaction. The patient was not taking Valtrex just ibuprofen and a tramadol for pain. The patient was due to receive the second vaccine on 07Apr2021 and was asking for advice. The patient also experienced that her teeth hurt and felt like it was grinding.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Limb discomfort, Pain in extremity
Clinical narrative: Arm was hurting; she lived through the arm pain; trouble sleeping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 13Mar2021 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation", start date: Dec2020 (ongoing), notes: Verbatim: AFib; "Covid-19", start date: Dec2020 (unspecified if ongoing), notes: Caller reported that she has been taking the blood thinner since Dec2020 when she had Covid-19. The patient took concomitant medications. Past drug history included: Levothyroxin for Thyroid, notes: Dose: Daily; Calcium for Stopped making own calcium, notes: Dose: Everyday; Coq-10, notes: Dose: Everyday, Doctor said it helps with heart medication.  The following information was reported: LIMB DISCOMFORT (non-serious) with onset 13Mar2021, outcome "recovered" (18Mar2021), described as "Arm was hurting"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "she lived through the arm pain"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "trouble sleeping".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (left shoulder), administration date 11Mar2021 (Lot number: EN6207, Expiration Date: 06Jun2021) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches". Therapeutic measures were taken as a result of headache. Treatment included Tylenol 500 mg.  Additional information: Patient received his first Pfizer BioNTech covid-19 vaccine on 11Mar2021, approximately 4 days later after the vaccine he experienced headache that had continued. Patient's second Pfizer BioNTech Covid 19 vaccine was scheduled for 01Apr2021. The patient was concerned about the side effect, headaches. When he took it he didn't have it right away, but now he was having headaches. Investigation Assessment was not provided.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Dysphonia, Throat irritation
Clinical narrative: had a hoarse, scratchy voice, actually lost her voice briefly about an hour; had a hoarse, scratchy voice, actually lost her voice briefly about an hour; scratching throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPHONIA (non-serious), APHONIA (non-serious) all with onset 29Mar2021, outcome "recovered" (29Mar2021) and all described as "had a hoarse, scratchy voice, actually lost her voice briefly about an hour"; THROAT IRRITATION (non-serious) with onset 29Mar2021, outcome "recovered" (29Mar2021), described as "scratching throat".  Additional Information: It was reported that the reporter's wife received her 1st Pfizer vaccine dose yesterday and had a hoarse, scratchy voice, actually lost her voice briefly about an hour after patient received the shot. Then it just went away. Reporter asked, was it ok if she gets the 2nd dose? Patient had a scratching throat kind a lost her voice for a little while, about an hour after patient injection for her first injection and patient was wondering will that side effect should impact or whether or not patient got her second injection or not. Patient asked should she go ahead to get the second injection couple of weeks later or not?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Lymphadenopathy
Clinical narrative: Earache in her right ear and it hurts when she puts her chin down.; Swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergies to grasses" (unspecified if ongoing); "allergies to mold" (unspecified if ongoing); "lost her hearing" (unspecified if ongoing), notes: She states she lost her hearing in her right ear a year ago. The patient's concomitant medications were not reported. The following information was reported: EAR PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Earache in her right ear and it hurts when she puts her chin down."; LYMPHADENOPATHY (non-serious) with onset Mar2021, outcome "unknown", described as "Swollen lymph nodes".  Additional information: Patient second dose is scheduled for 30Mar2021. She states that shortly after receiving her first dose of the vaccine she developed an earache in her right ear, and it hurts when she puts her chin down. She is wondering if she has swollen lymph nodes. She noticed that swollen lymph nodes were a possible side effects. She states she lost her hearing in her right ear a year ago. Patient stated, well she gets her second shot (Confirmed as Pfizer Covid vaccine) today, this afternoon and she was wondering, she just went down picked a paper which gets a card and she had read through the side effects and one of the side effects is swollen lymph nodes. Now she doesn't know, she gets allergies about this time of the year. She went to this store this morning, grocery shopping but it's her ear it kind of hurt and then it, sometime when she put her chin down, she can feel kind of ear canal, area underneath her chin back with the ear and which is like the allergies, she gets every year. So, she don't know, should go ahead and get the shot?". So further probing could not be done. Hence, Product details (LOT, Expiration date, NDC, UPC) and other patient details were unknown. Patient Seriousness Criteria-Caused/prolonged hospitalization: No. Patient Seriousness Criteria-Congenital anomaly/birth defect: No. Patient Seriousness Criteria-Disabling/Incapacitating: No. Patient Seriousness Criteria-Results in death: No. Patient Seriousness Criteria-Life threatening: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Headache; Feeling a little off/unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 80-years-old female patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADVIL. Vaccination history included: Bnt162b2 (First dose), when the patient was 80 years old, for COVID-19 immunization, reaction(s): "NO adverse event". The following information was reported: HEADACHE (non-serious) with onset 30Mar2021, outcome "unknown", described as "Headache"; MALAISE (non-serious) with onset 30Mar2021, outcome "unknown", described as "Feeling a little off/unwell".  Additional Information: Caller who was 80-years-old female received second dose of the PFIZER BIONTECH COVID-19 Vaccine yesterday. Today, she was feeling a little off/unwell and had a bit of a headache. She takes ELDERBERRY to boost her immune system. She saw online that you are not supposed to take TYLENOL or ADVIL before you get the COVID-19 Vaccine, but she did not see that on the fact sheets. She took ADVIL the morning of the vaccine (for chronic pain that she has) around 7am and had her vaccine around 12pm. She asked if does TYLENOL or IBUPROFEN affect the vaccine and why was the TYLENOL or IBUPROFEN CDC recommendations not on the Patient Fact Sheet. She was confused why it was on the Internet but no one was given any warning about it on the paperwork. She drank alcohol after her first dose and asked if does this affect the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Dizziness
Clinical narrative: He has read that with the second dose you could have more reactions. He will probably not take the second dose. dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: ER2613) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 26Mar2021, outcome "recovering", described as "dizziness"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "He has read that with the second dose you could have more reactions. He will probably not take the second dose.". Therapeutic measures were not taken as a result of dizziness.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nauseous; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Mar2021 (Lot number: EP7534) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTROGEN GEL taken for artificial menopause. The following information was reported: NAUSEA (non-serious) with onset 10Mar2021, outcome "not recovered", described as "nauseous". Therapeutic measures were taken as a result of nausea.  Additional information: The patient received her first dose on 08Mar2021 and the next day, 09Mar2021, she didn't have any symptoms. she felt a little nauseous on 10Mar2021 for the next three days and it was off and on. She stated that the nausea went away on 13Mar2021 and reoccurred this Monday, 29Mar2021 and wants to know if this is this related to the Covid vaccine and if she should be concerned. She reported that she works in the or as a sterile processor, she does the instruments. Patient reported she was feeling a little nauseous this morning, but it is improving at this time. The patient scheduled to receive her second dose on 08Apr2021. She received treatment with Pepcid AC, but clarified she took Pepto-Bismol. She wants to know if she should proceed with the next dose.  No follow-up attempts are possible. No further information is expected.