chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: 2 obvious swollen lymph nodes on collarbone and one still swollen; This is a spontaneous report from a contactable consumer, the patient. A 53-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 04Jun2021 at 10:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer, hypothyroidism and thyroid removal. The patient had allergy to penicillin. Concomitant medications included lovastatin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), ammonium succinate, calcium succinate, glutamate sodium, glycine, magnesium succinate, tocopheryl acetate, zinc difumarate hydrate (AMBEREN) and vitamin d nos (MANUFACTURER UNKNOWN); all taken for unknown indications from an unknown date and unknown if onging. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Jun2021 at 07:00, 7 days after vaccination, the patient experienced two obvious swollen lymph nodes on collarbone and one still swollen 14 days later at time of second dose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event 2 obvious swollen lymph nodes on collarbone and one still swollen was recovering at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Malaise, Vision blurred
Clinical narrative: Dizzy; vision started shaking; became very weak; felt sick; This is a spontaneous report from a contactable consumer, the patient. A 27-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 24Jun2021 at 13:30 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), naproxen (MANUFACTURER UNKNOWN) and essential oils (MANUFACTURER UNKNOWN) from unknown date for unknown indications. On 24Jun2021 at 15:30, a couple hours after receiving the vaccine, the patient became very weak and dizzy. It was the worst when she laid down. Her vision started shaking violently when she would then sit still at all for three to five minutes. It subsided, but she felt sick the rest of the day and the next morning. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event became very weak and dizzy. Her vision started shaking violently she would then sit still at all for three to five minutes, it subsided, but she felt sick the rest of the day and the next morning was recovered on 25Jun2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Lacrimation increased, Mobility decreased, Muscular weakness
Clinical narrative: Both sides of body-arms and hands were weak; Both sides of body-arms and hands were numb and tingly; Both sides of body-arms and hands were numb and tingly; Difficult to move hands; Both sides of jaw numb and tight; Itchy; Watery eyes; Tingly lips; This is a spontaneous report from a contactable consumer. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the left arm on 11Jun2021 at 17:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Jun2021 at 17:30, the patient experienced itchy, watery eyes and tingly lips. On 13Jun2021, third day after shot, the patient experienced both sides of body-arms and hands were weak, numb and tingly, difficult to move hands, both sides of jaw numb and tight and lips were extremely tingly. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events itchy, watery eyes, tingly lips, both sides of body-arms and hands were weak, numb, tingly, difficult to move hands, both sides of jaw numb and tight and lips were extremely tingly was unknown at the time of this report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Pruritus
Clinical narrative: Both sides of body-arms and hands were weak; Both sides of body-arms and hands were numb and tingly; Both sides of body-arms and hands were numb and tingly; Difficult to move hands; Both sides of jaw numb and tight; Itchy; Watery eyes; Tingly lips; This is a spontaneous report from a contactable consumer. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the left arm on 11Jun2021 at 17:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Jun2021 at 17:30, the patient experienced itchy, watery eyes and tingly lips. On 13Jun2021, third day after shot, the patient experienced both sides of body-arms and hands were weak, numb and tingly, difficult to move hands, both sides of jaw numb and tight and lips were extremely tingly. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events itchy, watery eyes, tingly lips, both sides of body-arms and hands were weak, numb, tingly, difficult to move hands, both sides of jaw numb and tight and lips were extremely tingly was unknown at the time of this report.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm that had injection was sore; This is a spontaneous report from a contactable consumer. A 17-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration on 23Jun2021 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had  not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Jun2021, the patient's arm that had injection was sore. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event arm that had injection was sore was recovered on unknown date in Jun2021.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Smell gunpowder even though there is no gunpowder around me; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration on 25Jun2021 at 10:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies (reported as N/A). Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 25Jun2021 at 22:00, the patient experienced smell gunpowder even though there was no gunpowder around patient. The event did not result in doctor or other healthcare professional office/clinic visit/emergency visit. No therapeutic measures were taken as a result of reported event. The clinical outcome of the event smell gunpowder even though there was no gunpowder around patient was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Intraocular pressure test
Clinical narrative: My intraocularpressure in my right eye was40mmHg.  My left eye was 14mmHg.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 21Apr2021 at 08:00 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the right arm on 29Mar2021 at 13:45 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 23Apr2021 at 14:00, two days after the second vaccination, the patient went for a regular eye exam (no complaints/symptoms). Her intraocular pressure in the right eye was 40mmHg and left eye was 14mmHg. The patient has never had elevated IOP.  Her exam showed no obvious signs of glaucoma. The doctor has no explanation and the vaccine was the only thing they could think it would be.  The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of intraocular pressure in the left and right eye which included treatment with glaucoma drops and was taken 2x/day for 1 week and 1x/day for 1 week. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event- intraocular pressure in the right eye was 40mmHg and left eye was 14 mmHg was recovered in 2021.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site swelling, Nausea, Pain
Clinical narrative: Nausea; Body ache, body pain; There is like a big knot at the injection site of the vaccine; Very large and protruding thats rock hard. Swelling of the injection site; Headache; Thinking that the vaccination did not go through the muscle and its like in the upper level of muscle, and thats why there is a knot and its really huge he mentioned; This is a spontaneous report from a contactable consumer (Patient) received from a Pfizer-sponsored program Support. A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 25Jun2021 14:05 as dose 2, single for Covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included citalopram (CITALOPRAM); atorvastatin (ATORVASTATIN); omeprazole (OMEPRAZOLE); colecalciferol (VITAMIN D SUPPORT)- all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunization and reported as product used for unknown indication. No other medical condition reported. No other vaccine taken 4 weeks prior to Pfizer Covid 19 Vaccine. On 26Jun2021, the patient experienced nausea, body ache, body pain, there is like a big knot at the injection site of the vaccine; very large and protruding thats rock hard. swelling of the injection site, headache, and on 25Jun2021 thinking that the vaccination did not go through the muscle and its like in the upper level of muscle, and thats why there is a knot and its really huge he mentioned. Consumer stated that he don't remember the first dose exact appointment and Lot numbers as he don't have his vaccination card right now as his wife had it, she is not home yet. No, not right now she put it in the purse at the store. Patient didn't get any symptoms until this morning and wanted to know if he would be doing like a warm compress or hot compress, he mean cold compress or if he can take the Ibuprofen. And also was there any concern like if there could be an allergic reaction. Outcome of the events was not resolved.  Information about lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Micturition urgency, Nausea
Clinical narrative: 24th 3am episode of being woken by it at base of skull; slight breathlessness; Nausea; chills; need to go to the bathroom; disrupted ability to fall asleep and continued fatigue during daily activities; felt a slight tremor that she noticed at bedtime when quiet to the point of taking celebrex to relax and rest.; The patient experienced fatigue and drain; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8730) dose 2 via an unspecified route of administration in left arm on 08Jun2021, 02:00 PM (at the age of 55-year-old) as single dose for COVID-19 immunisation at Public Health Clinic/Veterans Administration facility. Medical history included autoimmune inflammatory, food sensitivities. Concomitant medications included unspecified medications in two weeks. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID- 19. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0186) dose 1 via an unspecified route of administration in left arm on 18May2021 01:30 PM, (at the age of 55-year-old) as single dose for COVID-19 immunisation. Also took codeine and had known allergies. On 11Jun2021 04:00 PM, after 2nd dose, fatigue and drain. By 12Jun2021-13Jun2021, felt a slight tremor that she noticed at bedtime when quiet to the point of taking celebrex to relax and rest. By 14Jun2021 pm bedtime was more aware of the consistent tremor at bedtime upon laying down, which disrupted ability to fall asleep and continued fatigue during daily activities. By 22Jun2021, 23Jun2021, feeling the constant tremor and kept busy by day to ignore it. 24Jun2021 3am episode of being woken by it at base of skull, slight breathlessness, nausea, chill, need to go to the bathroom. Felt better upon standing or sitting up, not laying down. Got up for the day to keep mind off of it. Next night hard to get comfortable with tremor at laying still, finally rest came and was awoken at 4am on 25Jun2021 with same experience only more. Thirdly, night of 25Jun2021 near 12am 26Jun2021 2 am even more intense experience with the episode described above. Stayed in bed on 26Jun2021 during the day, sitting angle, as well as 27Jun2021 today. Still experiencing it. Events resulted in Doctor or other healthcare professional office/clinic visit. Received treatment with medications. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality sleep, Sleep disorder, Tremor
Clinical narrative: 24th 3am episode of being woken by it at base of skull; slight breathlessness; Nausea; chills; need to go to the bathroom; disrupted ability to fall asleep and continued fatigue during daily activities; felt a slight tremor that she noticed at bedtime when quiet to the point of taking celebrex to relax and rest.; The patient experienced fatigue and drain; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8730) dose 2 via an unspecified route of administration in left arm on 08Jun2021, 02:00 PM (at the age of 55-year-old) as single dose for COVID-19 immunisation at Public Health Clinic/Veterans Administration facility. Medical history included autoimmune inflammatory, food sensitivities. Concomitant medications included unspecified medications in two weeks. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID- 19. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0186) dose 1 via an unspecified route of administration in left arm on 18May2021 01:30 PM, (at the age of 55-year-old) as single dose for COVID-19 immunisation. Also took codeine and had known allergies. On 11Jun2021 04:00 PM, after 2nd dose, fatigue and drain. By 12Jun2021-13Jun2021, felt a slight tremor that she noticed at bedtime when quiet to the point of taking celebrex to relax and rest. By 14Jun2021 pm bedtime was more aware of the consistent tremor at bedtime upon laying down, which disrupted ability to fall asleep and continued fatigue during daily activities. By 22Jun2021, 23Jun2021, feeling the constant tremor and kept busy by day to ignore it. 24Jun2021 3am episode of being woken by it at base of skull, slight breathlessness, nausea, chill, need to go to the bathroom. Felt better upon standing or sitting up, not laying down. Got up for the day to keep mind off of it. Next night hard to get comfortable with tremor at laying still, finally rest came and was awoken at 4am on 25Jun2021 with same experience only more. Thirdly, night of 25Jun2021 near 12am 26Jun2021 2 am even more intense experience with the episode described above. Stayed in bed on 26Jun2021 during the day, sitting angle, as well as 27Jun2021 today. Still experiencing it. Events resulted in Doctor or other healthcare professional office/clinic visit. Received treatment with medications. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Chest pain; Shortness of breath; This is a spontaneous report from a contactable consumer (reporting for son)  A 14-year-old male patient received BNT162B2 (Solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date (this past Saturday) at the age of 14-year-old, as dose number unknown, single, for Covid-19 immunization. Medical history and concomitant medications were not reported. The patient was currently experiencing chest pain and shortness of breath. It just started in the early hours on 28Jun2021 (reported as this morning). Both started about 3:00 this morning and has stayed the same. Treatment: None, that is what re-porter was trying to figure out, if she should take him to the emergency room and stating she was going to take him to the ER. The outcome of the events was reported as not recovered.    Information about batch/lot number has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Parosmia
Clinical narrative: lost the sense of smell of specific scents; missing the ability to properly detect the volatile sulfur scents; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male 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 30Mar2021 at 16:00 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other medications within two weeks prior to the vaccination. 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 09Mar2021 at 08:00 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. On 17Apr2021, after about two weeks after the last injection, the patient lost the sense of smell of specific scents. The patient was missing the ability to properly detect the volatile sulfur scents. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events lost the sense of smell of specific scents and missing the ability to properly detect the volatile sulfur scents was not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Hypoaesthesia, Pyrexia
Clinical narrative: low fever; Fatigue/tired; Weakness; Numbness; This is a spontaneous report from a contactable consumer. This is a second case out of 2 cases. (patient reported for self). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0180; Expiration date: UNKNOWN) via an unspecified route of administration, administrated at Arm Left on 10Jun2021 as dose 2, single for COVID-19 immunisation. The medical history type 2 diabetes mellitus from an unknown date and unknown if ongoing. The concomitant medications were not reported. The patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE /Lot number: EW0187) via an unspecified route of administration, administrated at left arm on 20May2021 for COVID-19 immunization. On an unspecified date, after the second dose the patient has been going through a lot of fatigue/tired, weakness, numbness. The patient stated after dose 2 he did not feel any change. He meant he was okay. The patient stated as far as he remembers almost every day, has been getting temperatures. Low fevers. The patient stated he did not feel anything, any serious kind of a thing that was just temperature was up and down that he could feel, and he was taking Ibuprofen. The patient stated now they were concerned that was has been a little longer than that and almost 20 days especially for his wife, she is experiencing the same kind of symptoms every day. The patient clarified that he was treated with Ibuprofen for pain or for the fever. Outcome of the events was unknown. Further probing could not be done. Limited information available over the call.  Follow-up attempts are completed.  No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Influenza like illness, Reduced facial expression
Clinical narrative: half of face is numb; tongue is numb; smile is off; flu like symptoms; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 27-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot Number: EW0187) via an unspecified route of administration, administered in left arm on an unspecified date in Jun2021 on Friday at 09:15 as single dose for covid-19 immunization. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number: EW0173) via an unspecified route of administration, administered in left arm on 06May2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Jun2021, the patient experienced flu like symptoms on Saturday. On 27Jun2021, the patient experienced half of face is numb, tongue is numb and smile is off. Patient reported that she feels like she is going crazy and she received her second dose of the Pfizer-Biontech Covid19 vaccine this past Friday. On Saturday, she experienced flu-like symptoms, as she expected, which resolved by Sunday. On Sunday, she noticed that half of her face is numb, her tongue is numb, her smile is off. She wants to know if these symptoms have been reported before and she got answer as per fact sheet Bell's palsy (facial paralysis) was reported by four participants in the Pfizer-BioNTech COVID-19 Vaccine group. Onset of facial paralysis was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of Bell's palsy were reported in the placebo group. Currently available information is insufficient to determine a causal relationship with the vaccine. The outcome of the event flu like symptoms was recovered on Sunday 27Jun2021 and outcome of the remaining events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on 22Jun2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 22Jun2021, patient experienced diarrhea and complaining about diarrhea for the last 6 days (for a week now). Patient wanted to know the treatment and how long will this last, what was going to happen and what was going on with his body. Patient was advised to contact his doctor/healthcare provider. The outcome of the event was not recovered.  Information about lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Musculoskeletal pain
Clinical narrative: pain in her lower back; pain in her buttocks; pain in her knees; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number, NDC number, expiry date, RX number: unknown) via an unspecified route of administration on 26Jun2021 at 08:20 (at the age of 61-years-old) in left upper arm as a single dose for covid-19 immunization. The patient's medical history (including any illness at time of vaccination) and investigation assessment were not reported. She started a new prescription (unknown concomitant medication). Additional vaccines administered on same date of the Pfizer suspect was reported as none. Family medical history relevant to adverse events was not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Batch/lot number, NDC number, expiry date, RX number: unknown, route, anatomical location: not provided) on 05Jun2021 (at the age of 61-years-old) for covid-19 immunization and did not had any problem. Prior vaccinations within 4 weeks included Tetanus shot (manufacturer, lot number, route, anatomical location: not provided) on an unknown date. The patient experienced pain in her lower back, buttocks, and knees on 27Jun2021. She did not require emergency room and physician office visit. She couldn't think of anything that may had caused the events, but she didn't saw the list of side effects on the EUA fact sheet. Relevant tests were reported as none. The outcome of the events was not resolved.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Influenza like illness, Pain, Pyrexia
Clinical narrative: flu like symptoms; fever; felt really achy; This is a spontaneous report from a contactable Nurse. This Nurse reported for a male patient (reporter's son). The male patient of an unspecified age received bnt162b2 (COMIRNATY, Solution for injection, Lot Number/Batch no: unknown), dose unknown via unspecified route of administration on unknown date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's medical history had included Covid 19 virus in Dec2020. Concomitant medications were not reported. The patient previously took past drug ibuprofen before getting his Covid 19 vaccines. On an unspecified date, the patient experienced flu like symptoms, fever and felt really achy. It was reported that, her own experience with the Covid 19 vaccine she reports her son felt worse than she did with flu like symptoms and a fever and felt really achy. The reporter was glad her son did not have bad side effects. The patient underwent lab tests and procedures, which included Covid 19 virus was diagnosed as having Covid 1 9 positive on dec2020. She had declined to file a safety report for her son. No further information is provided or obtained. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy
Clinical narrative: began experiencing chills, fatigue, swollen lymphnodes; began experiencing chills, fatigue, swollen lymphnodes; began experiencing chills, fatigue, swollen lymphnodes; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer reported that:   A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on 17Jun2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 23Jun2021, the patient experienced chills, fatigue and swollen lymphnodes. The outcome of events was unknown.   Information on the lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis acneiform
Clinical narrative: Pimply rash on neck and trunk; 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: EW0180) via an unspecified route of administration in the left arm on 23Jun2021 at 16:30 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy, sulfonamide allergy and COVID-19. Concomitant medications included aciclovir sodium (ACYCLOVIR) and losartan potassium (LOSARTIN). Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Jun2021, the patient experienced pimply rash on neck and trunk. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the event pimply rash on neck and trunk was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperaesthesia, Paraesthesia, Paraesthesia oral, SARS-CoV-2 test
Clinical narrative: Paresthesia and hyperesthesia of extremities up to elbows/ knees and perioral as well as hyperesthesia of trunk and scalp; Paresthesia and hyperesthesia of extremities up to elbows/ knees and perioral as well as hyperesthesia of trunk and scalp; Paresthesia and hyperesthesia of extremities up to elbows/ knees and perioral as well as hyperesthesia of trunk and scalp; This is a spontaneous report from a contactable physician, the patient. A 45-year-old male 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 02Jun2021 at 09:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included viral infection, paresthesia, hyperesthesia, perioral paresthesia (reported as had similar symptoms after a viral illness that started in November and worsened in January to above but had completely resolved (negative Covid testing and antibodies during work up)). The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Jun2021 at 04:00 the patient experienced paresthesia and hyperesthesia of extremities up to elbows/ knees and perioral as well as hyperesthesia of trunk and scalp. No therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On an unknown date, the patient underwent COVID- 19 test and the result was negative. The clinical outcome of the events paresthesia and hyperesthesia of extremities up to elbows/ knees and perioral as well as hyperesthesia of trunk and scalp was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid rash, Fatigue, Hordeolum, Pain in extremity, Pyrexia
Clinical narrative: Developed a sty on left eyelid; Eyelid still has a rash; Sore arm; Fatigue; Minor fever; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0164) via an unspecified route of administration in the left arm on 15Apr2021 at 11:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included BIRTH CONTROL for an unknown indication received within two weeks of vaccination. The patient also received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number:ER8734 ) via an unspecified route of administration in the left arm on Mar2021 at 11:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 the patient developed a sty on my left eyelid the day of vaccination. The left eyelid of the patient still had a rash. The patient did not think that she would have a sty in 15 years which Could be coincidence, but she wanted to report if helpful to understand potential inflammatory responses. The patient experienced other known side effects (sore arm, fatigue, minor fever, etc.) which lasted a day, but these were all to be expected. The sty was the side effect that seemed weird to her. No therapeutic events were taken as a result of the reported adverse events. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of sty on left eyelid, eyelid still had a rash, sore arm, fatigue and minor fever were recovered with sequelae.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain, Pain in extremity, Pruritus
Clinical narrative: itching at injection site; stinging; joint pain/ she was having pain throughout her body, a shooting pain in her wrist, feet, shoulders, arms, and had headaches.; she was having pain throughout her body, a shooting pain in her wrist, feet, shoulders, arms, and had headaches.; she was having pain throughout her body, a shooting pain in her wrist, feet, shoulders, arms, and had headaches.; headache; pain at injection site; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183), dose 2 via an unspecified route of administration, administered in Arm Left on 24Jun2021 16:50 as a single dose for covid-19 immunization. Medical history included anaemia -diagnosed in 2017 or 2018. She really wasn't taking anything, her doctor had put her on allergy pills, but had not been taking it the two weeks leading up to the second dose. He has iron pills, but clarifies she's been off of them, and hasn't been having to take them now, for about four weeks. She clarifies the anemia has been on and off, severe, since maybe 2017 or 2018. Concomitant medication(s) included colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient previously took iron. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration, administered in Arm Left on 03Jun2021 16:43 as a single dose for covid-19 immunization. The patient had no other vaccine within four weeks and no AE(s) following prior vaccinations. She clarifies arm kind of itches, and she is wondering if she can put some alcohol on her arm. On 25Jun2021, Saturday (24-hour clock, unknown time, earlier in the day), she had joint pain and a headache, and it's a little better. She was having pain throughout her body, a shooting pain in her wrist, feet, shoulders, arms and pain at injection site. On 27Jun2021, now at the site where she had the shot, it's itching, she almost feels like she wants to scratch her arm. She has experienced itching at injection site, and "feels like it's stinging" at injection site. Caller was asking if she can put alcohol on her left arm for complaints of itching and stinging. The patient was treated with a BC Powder, a packet of powder, individual packet, took it on 25 Jun2021 for the pains throughout her body and headache. The adverse event did not require a visit to emergency room and physician office. Therapeutic measures were taken as a result of headache and stinging (pain). Outcome of the event stinging, itching at injection site was not recovered; headache, arthralgia was recovering; pain at injection site, pain in extremity was unknown. Information on Lot/Batch number was available. Additional information has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: itching at injection site; stinging; joint pain/ she was having pain throughout her body, a shooting pain in her wrist, feet, shoulders, arms, and had headaches.; she was having pain throughout her body, a shooting pain in her wrist, feet, shoulders, arms, and had headaches.; she was having pain throughout her body, a shooting pain in her wrist, feet, shoulders, arms, and had headaches.; headache; pain at injection site; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183), dose 2 via an unspecified route of administration, administered in Arm Left on 24Jun2021 16:50 as a single dose for covid-19 immunization. Medical history included anaemia -diagnosed in 2017 or 2018. She really wasn't taking anything, her doctor had put her on allergy pills, but had not been taking it the two weeks leading up to the second dose. He has iron pills, but clarifies she's been off of them, and hasn't been having to take them now, for about four weeks. She clarifies the anemia has been on and off, severe, since maybe 2017 or 2018. Concomitant medication(s) included colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient previously took iron. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration, administered in Arm Left on 03Jun2021 16:43 as a single dose for covid-19 immunization. The patient had no other vaccine within four weeks and no AE(s) following prior vaccinations. She clarifies arm kind of itches, and she is wondering if she can put some alcohol on her arm. On 25Jun2021, Saturday (24-hour clock, unknown time, earlier in the day), she had joint pain and a headache, and it's a little better. She was having pain throughout her body, a shooting pain in her wrist, feet, shoulders, arms and pain at injection site. On 27Jun2021, now at the site where she had the shot, it's itching, she almost feels like she wants to scratch her arm. She has experienced itching at injection site, and "feels like it's stinging" at injection site. Caller was asking if she can put alcohol on her left arm for complaints of itching and stinging. The patient was treated with a BC Powder, a packet of powder, individual packet, took it on 25 Jun2021 for the pains throughout her body and headache. The adverse event did not require a visit to emergency room and physician office. Therapeutic measures were taken as a result of headache and stinging (pain). Outcome of the event stinging, itching at injection site was not recovered; headache, arthralgia was recovering; pain at injection site, pain in extremity was unknown. Information on Lot/Batch number was available. Additional information has been requested. Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Lip swelling
Clinical narrative: Her nose went numb pretty immediately and lips were swelling about 8 - 10 hours later; Had some arm discomfort; Her nose went numb pretty immediately and lips were swelling about 8 - 10 hours later; This is a spontaneous report from a contactable consumer or other non hcp. A 26-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection), intramuscular administered in Arm on 21Jun2021 (Batch/Lot number was not reported) (at the age of 26-years-old) as SINGLE for covid-19 immunization. Medical history included ongoing Hashimoto's thyroiditis from 2018 and allergies to shrimp and grass from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for Hashimoto's thyroiditis from 2018 to an unspecified stop date. She was diagnosed 3 years ago and that's when she was put on Synthroid. Patient had a reaction almost immediately after vaccination with nose going numb that lasted about an hour. She didn't tell the person there that she was having a reaction. She noticed that night, 8-10 hours later, her lips swelled up. that's typical to how she has an allergic reaction to something, her lips and mouth swell up (At 22:00). She didn't take a Benadryl even though mother thinks she should have. Caller stated she herself had discomfort in her arm for a couple of days. Patient had reactions to shrimp in the past and they've gotten worse and caller thinks she needs to get an EpiPen because it has gotten worse and swelling has spread through nose and mouth. Caller clarified patient did not have this reaction to Covid 19 Vaccine. Caller wanted to know if her daughter should get the second shot or not. No relevant testing but caller states that every 6 months blood work for thyroid issue. The outcome of event numbness was recovered on 21Jun2021 whereas, other events was recovered on 22Jun2021.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: Ear starting to feel "stopped up" or clogged; Mild ringing in left ear; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0217) via an unspecified route of administration in the left arm on 26Jun2021 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination.  On 26Jun2021  at 18:00, after her first vaccination, the patient experienced a very mild ringing in her left ear. The ringing had continued but was still mild at the time of this report. On 28Jun2021, the patient ear started to feel "stopped up" or clogged. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. The clinical outcome of the event mild ringing in left ear and ear started to feel "stopped up" or clogged was not recovered at the time of this report.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pruritus, Pyrexia, Urticaria
Clinical narrative: Fever of 100. 8; 8Hives on arm; Itching; This is a spontaneous report from a contactable consumer, the patient. A 56-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 right arm on 22Jun2021 at 12:30 as a single dose for COVID-19 immunisation. The patient medical history included lupus. The patient received unspecified other medication within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in 2021 as a single dose for COVID-19 immunisation and also received tetanus and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Jun2021 at 00:00, the patient experienced fever of 100. 8, hives on arm and itching. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. On 23Jun2021 at 00:00, the patient underwent body temperature and the result was 100. 8(unit unspecified). The clinical outcome of the events fever of 100. 8, hives on arm and Itching was resolving at the time of this report.   Information about lot/batch number has been requested.