chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Migraine, Pain
Clinical narrative: Chills; body pain; migraine; headache; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 55 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation solution for injection; Lot Number: EL9269) via intramuscular route, administered in Left Arm on 12Feb2021 at 17:30 (at the age of 55-year-old) as a Dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications within 2 weeks after vaccination were reported as none. No known allergies were reported. Vaccination facility type was reported as Other. The patient had not received any other vaccine within 4 weeks prior to Covid vaccination. The patient was not diagnosed with Covid prior to vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation solution for injection; Lot Number: EL9262) via intramuscular route, administered in Left Arm on 26Jan2021 (at the age of 55-year-old) as a Dose 1, single for COVID-19 immunization. She mentioned that with her first dose (26Jan2021) she did not have any reaction, but with her second dose (12Feb2021) well past a few hours she began to feel chills, body pain and migraine, headache. Since vaccination the patient was not tested for Covid. No treatment medications received for the events. The outcome of the events was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Panic attack
Clinical narrative: Panic attack; 2 weeks delayed in her regular mensuration; This is a spontaneous report received from a non-contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration, administered on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced panic attack on an unspecified date. Patient was stated that after couple of weeks ago she got the first vaccine and after 5 hours, she experienced panic attack. So, she wanted to know about the vaccine and if it was possible to happen again if she gets the second dose and she was already 2 weeks delayed in her regular mensuration. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Pain in extremity, Vomiting
Clinical narrative: Nausea; Vomiting; He is not feeling well; Arm being a little sore; Muscle ache; This is a spontaneous report from a contactable consumer (patient's wife).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6201; Expiration Date: 30Jun2021), via an unspecified route of administration on 16Feb2021 as dose number unknown, single for COVID-19 immunisation. Medical history included chemotherapy 2 years ago from unspecified date in 2019. The patient's concomitant medications were not reported. On an unspecified date in Feb2021, after the patient's shot, it was reported that the patient felt fine other than his arm being a little sore and then he had some muscle ache but felt well enough. So he decided to go to do his exercise program on the day of the report (17Feb2021) and swim laps. While the patient was swimming he got sudden nausea and he threw up, he had vomiting. The patient was well enough to get home. The reporter thought the patient did too much activity too soon after having the vaccine but he didn't have any symptoms, he was well enough, his appetite was really good in the morning of the report and everything. It was further reported that the patient does have some nausea medicine (treatment), he had chemotherapy 2 years ago (history). Then on an unspecified date in Feb2021, the patient was not feeling well and still feeling that until the day of reported. Unspecified treatment was given in response of the events nausea and vomiting. Outcome of event "not feeling well" was not recovered and unknown for all other events.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Feeling abnormal, Feeling hot, Heart rate, Heart rate increased
Clinical narrative: Warm feeling in left arm at injection site and face; Warm feeling in left arm at injection site and face; Increased heart rate; Salty taste in mouth; Head felt out of touch; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN9581, Expiration date were not reported), intramuscularly, administered in the left arm on 30Jan2021 13:15 (at the age of 62-years-old), as dose 1, single for COVID-19 immunisation. Medical history included high blood pressure and palpitations. Concomitant medications included metoprolol succinate (TOPROL, 50 mg Tablet) taken for high blood pressure and palpitations, patient has been on it for 20 years; loratadine (CLARITIN) taken as premedication for vaccination from 30Jan2021; and levothyroxine sodium (SYNTHROID). Patient had no additional vaccines administered on same day of BNT162B2. Patient also has no history of previous immunization with Pfizer vaccine considered as suspect. On 30Jan2021, the patient experienced warm feeling in left arm at injection site and face (1-2 minutes after vaccine), increased heart rate (3-4 minutes after vaccine), salty taste in mouth (3-4 minutes after vaccine), and head felt out of touch (3-4 minutes after vaccine). It was reported that patient knew it was a personal choice of whether or not to get second dose, but she had a brief reaction from the first one. It felt like when you get IV contrast. In a matter of minutes, it was a warm feeling in her injection site arm and face and then her heart rate increased, but not dangerously high. She then had a salty taste in her mouth and her head felt out of touch for a few minutes. She can't really tell if it was related. It only lasted a few minutes and completely resolved. She was fine after that and went food shopping with no ill effects. She thought it was probably some additive in the vaccine because it happened so quickly. Some people said she had a Vaso-Vagal response and she said no. She is due for 2nd vaccine on Saturday. She wanted to know if anyone has any insight about any of the additives that may have caused this. Patient stated that the increased heart rate followed flushed face. She then stated it was not flushed but warm. She took a loratadine (CLARITIN) that morning because she heard horror stories and she did not know what vaccine she was getting. She wondered if her reaction would have been worse if she did not have that. She then said, if she wasn't on a beta blocker, maybe the heart rate would have been higher and maybe that prevented her from having a worse reaction. The events were reported as non-serious.  The patient underwent lab tests and procedures which included heart rate: increased on 30Jan2021. Events did not result to emergency room and physician office visit. The outcome of events was recovered on 30Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Warm feeling in left arm at injection site and face; Warm feeling in left arm at injection site and face; Increased heart rate; Salty taste in mouth; Head felt out of touch; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN9581, Expiration date were not reported), intramuscularly, administered in the left arm on 30Jan2021 13:15 (at the age of 62-years-old), as dose 1, single for COVID-19 immunisation. Medical history included high blood pressure and palpitations. Concomitant medications included metoprolol succinate (TOPROL, 50 mg Tablet) taken for high blood pressure and palpitations, patient has been on it for 20 years; loratadine (CLARITIN) taken as premedication for vaccination from 30Jan2021; and levothyroxine sodium (SYNTHROID). Patient had no additional vaccines administered on same day of BNT162B2. Patient also has no history of previous immunization with Pfizer vaccine considered as suspect. On 30Jan2021, the patient experienced warm feeling in left arm at injection site and face (1-2 minutes after vaccine), increased heart rate (3-4 minutes after vaccine), salty taste in mouth (3-4 minutes after vaccine), and head felt out of touch (3-4 minutes after vaccine). It was reported that patient knew it was a personal choice of whether or not to get second dose, but she had a brief reaction from the first one. It felt like when you get IV contrast. In a matter of minutes, it was a warm feeling in her injection site arm and face and then her heart rate increased, but not dangerously high. She then had a salty taste in her mouth and her head felt out of touch for a few minutes. She can't really tell if it was related. It only lasted a few minutes and completely resolved. She was fine after that and went food shopping with no ill effects. She thought it was probably some additive in the vaccine because it happened so quickly. Some people said she had a Vaso-Vagal response and she said no. She is due for 2nd vaccine on Saturday. She wanted to know if anyone has any insight about any of the additives that may have caused this. Patient stated that the increased heart rate followed flushed face. She then stated it was not flushed but warm. She took a loratadine (CLARITIN) that morning because she heard horror stories and she did not know what vaccine she was getting. She wondered if her reaction would have been worse if she did not have that. She then said, if she wasn't on a beta blocker, maybe the heart rate would have been higher and maybe that prevented her from having a worse reaction. The events were reported as non-serious.  The patient underwent lab tests and procedures which included heart rate: increased on 30Jan2021. Events did not result to emergency room and physician office visit. The outcome of events was recovered on 30Jan2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Affective disorder
Clinical narrative: Upset; This is a spontaneous report from a contactable consumer or other non hcp (female).   A female patient of an unspecified age received bnt162b2 (CONMINTARY, Solution for injection, Lot No: EL9266), via an unspecified route of administration on 16Feb2021 as 1stdose, single for covid-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing I just had breast cancer (Intent: History).The patient's concomitant medications were not reported. The patient experienced upset on an unspecified date. Patient stated that they gave me (incomplete sentence), they scheduled me 4 weeks later. Now I am hearing that you should get within 3 weeks. I am wondering why they schedule me for 4 weeks later. I wanted to know proper procedure. They gave me date for 4 weeks later, but I am hearing from other people that it should be 3 weeks later. I wanted to know what correct procedure is. Upon follow -up on 25Feb2021 new information has been updated is a follow-up spontaneous report from a contactable consumer. This consumer reported for herself patient characteristics (Sex), drug information (Pfizer-Biontech Covid-19 Vaccine). Patient received first Pfizer covid vaccine dose on 16Feb2021and currently scheduled for second Pfizer covid vaccine four weeks after her first dose. Patient is asking when she should receive her second dose. Outcome of the event was unknown.    Follow-up (25Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for herself patient characteristics (Sex), drug information (Pfizer-Biontech Covid-19 Vaccine). Patient received first Pfizer covid vaccine dose on 16Feb2021and currently scheduled for second Pfizer covid vaccine four weeks after her first dose. Patient is asking when she should receive her second dose.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arms are little sore you have to think about it to think it was sore; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported similar events for 2 patients. This is 1st of 2 reports. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported (BNT162B2), via an unspecified route of administration on 15Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. On an unspecified date, the patient experienced arms are little sore you have to think about it to think it was sore. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021202608 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chills, Feeling abnormal, Malaise
Clinical narrative: I just got a funny feeling; I am getting lot of chills; Blood pressure is keeps going up (160, 170; was 185 over 90); Nervous; does not feel good; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, when the patient was watching television, they just got a funny feeling, got lot of chills, blood pressure kept going up, was nervous and does not feel good. It was reported that during the night the patient was like 160, 170 and when the patient took it (reported as now), it was 185 over 90, that they don't feel. It was reported that the patient was worried about the side effects. The outcome of the events was unknown.  No follow-up attempts are needed, information on the lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nervousness
Clinical narrative: I just got a funny feeling; I am getting lot of chills; Blood pressure is keeps going up (160, 170; was 185 over 90); Nervous; does not feel good; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, when the patient was watching television, they just got a funny feeling, got lot of chills, blood pressure kept going up, was nervous and does not feel good. It was reported that during the night the patient was like 160, 170 and when the patient took it (reported as now), it was 185 over 90, that they don't feel. It was reported that the patient was worried about the side effects. The outcome of the events was unknown.  No follow-up attempts are needed, information on the lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arms are little sore; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is one of the two reports.  A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as dose 2, single, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on an unspecified date for COVID-19 immunization. On an unspecified date, after the second dose of vaccination, the patient's arms were a little sore. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number could not be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021202226 same reporter/product/events, different patient
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Euphoric mood
Clinical narrative: I received my second vaccine 15Feb and the next morning 16Feb my mood increased to euphoria; This is a spontaneous report from a contactable consumer. A 59-years-old non-pregnant female patient received second dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 15Feb2021 at 15:00 (at the age of 59-years-old) as single dose for covid-19 immunisation. Patient previously received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included hypothyroid, bipolar depression and hx of cancer. Patient had no known allergies. Concomitant medications included levothyroxine sodium (LEVOXYL), lamotrigine (LAMICTAL) and lithium. It was unknown if patient received any other vaccine in four weeks. Patient was not diagnosed with COVID prior to vaccination. Patient was not tested for COVID post vaccination. On 16Feb2021, patient experienced, after receiving the second dose of vaccine the next morning her mood increased to euphoria. Patient reported that she was stable on the medication for bipolar. Therapeutic measures were not taken due to the events. The outcome of the event was recovered on unspecified date in Feb2021.  Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza, Limb discomfort
Clinical narrative: Headache; Flu; Arm ill; This is a spontaneous report from a non-contactable consumer (patient) through a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as dose 1, single, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had headache, flu and arm was ill. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Joint injury
Clinical narrative: throbbing knees; This is a spontaneous report from a contactable pharmacist.   A 75-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 intramuscular on 22Feb2021 12:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. She received historical vaccine bnt162b2 (BNT162B2), dose 1 intramuscular on 30Jan2021 02:00 PM (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced throbbing knees leading to joint injury on 23Feb2021 14:00 with outcome of recovered.    Upon follow- up(02Mar2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included, A case from patient who received COVID-19 vaccine and experienced "throbbing knees". asking to provide the Pfizer receipt date (PRD)? The Pfizer receipt date (PRD) is the calendar day that the first Pfizer colleague or person working on behalf of Pfizer first receives information of an AE. responds to the email earlier today. and believe it was received on 23Febuary,  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: headache; body aches; This is a spontaneous report from a contactable consumer (patient) via a regulatory authority. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on 09Feb2021 09:45 (lot number: em9810; expiry date: unknown) at the age of 46-years-old, as dose 1, single for Covid-19 immunisation. The patient's medical history was not reported. The patient was not taking concomitant medications.The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient has not been tested for COVID-19 since vaccination. On 09Feb2021 12:00, the patient experienced headache and body aches. The patient did not receive treatment for the events. The patient recovered from the events on unspecified date.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pain in extremity
Clinical narrative: headache; sore arm; flu-like symptoms; This is a spontaneous report from a non-contactable consumer (patient). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 09Feb2021 16:45 (lot number: em9810; expiry date: unknown) at the age of 27-years-old, as dose 1, single, for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The vaccine was administered in a pharmacy/drug store. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient has not been tested for COVID-19 since vaccination. The patient experienced headache, sore arm, and flu-like symptoms on 10Feb2021. The patient did not receive treatment for the events. Outcome of the events was recovered on unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain
Clinical narrative: Head feels cloudy; Body aches; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: El3247) via an unspecified route of administration, administered in left arm on 16Feb2021 14:00 (at the age of 43 years old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient has had no COVID prior to vaccination. The patient has no known allergies. There were no other vaccines in four weeks and no other medications in two weeks. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. The patient experienced head feels cloudy and body aches on 17Feb2021 12:00. No treatment was given in response to the events. The patient was not tested for COVID post vaccination. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pain in extremity
Clinical narrative: fatigue; I had slight muscle soreness; Very slight chills; My right arm was also a bit sore; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 25-year-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in arm right on 15Feb2021 09:00 (at the age of 25-year-old) at dose 2, single for covid-19 immunisation. Medical history included Slight allergy to Amoxil, Covid-19 (If Covid prior vaccination: Yes). Patient did not receive other vaccine in four weeks. Patient has not tested for covid post vaccination. Concomitant medication included fluoxetine (FLUOXETINE); ethinylestradiol, levonorgestrel (KURVELO) (Other medications in two weeks) both taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in arm right on 25Jan2021 16:00 at dose 1, single for covid-19 immunisation. On 15Feb2021 14:00 the patient experienced I had slight muscle soreness, fatigue, and very slight chills. My right arm was also a bit sore. Patient did not receive treatment for the adverse events. Outcome of the events was resolved on an unspecified date in 2021.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Nausea, Pain
Clinical narrative: Dizziness after sleeping; Soreness; nausea; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the right arm on 16Feb2021 13:30 (Lot Number: Ez9266) as dose 1, single for COVID-19 immunization. The patient did not have any medical history. The patient did not have any known allergies. The patient did not have COVID prior to the vaccination. Concomitant medication included ibuprofen (manufacturer unknown) taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccines in four weeks prior to the vaccination. The patient was not tested for COVID post vaccination. On 17Feb2021 at 02:30, the patient experienced dizziness after sleeping, soreness, nausea and diarrhea. The patient did not receive treatment for the events. The patient was recovering from the events.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's husband) reported that a female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was experiencing migraine on an unknown date, after the first dose and wants to take Tylenol. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Wrong technique in product usage process
Clinical narrative: she had a 2x2 red ring around the injection site; shaking the vials like a "paint can" and administered her vaccine low close to the elbow; This is a spontaneous case received from a contactable consumer (patient) via COVAX US Support. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot/batch number was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was stated that they were shaking the vials like a paint can and administered her vaccine low close to the elbow, caller said Onsite was fired the second day, Caller also stated she had a 2x2 red ring around the injection site for a couple of days. The outcome of the events was unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Headache, Lymphadenopathy, Malaise, Muscle spasms
Clinical narrative: lymph node was swollen; Rash on my both sides and on my both arm; Not feeling well; Pain on lower left side of back; Muscle spasms; Headache; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 71-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry: Unknown, Age at vaccination: 71 years) via an unspecified route of administration on 10Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history was not reported and there were no concomitant medications. The patient previously received bnt162b2 (lot number: E18982 or EL8982, Expiry: Unknown) as dose 1 on 20Jan2021 for COVID-19 immunisation. On 11Feb2021 the patient experienced muscle spasms, headache, on 13Feb2021 the patient experienced not feeling well, pain on lower left side of back, on 17Feb2021 it was reported that rash on my both sides and on my both arm and on unspecified date patient experienced lymph node was swollen. Patient went to see primary care and was prescribed a couple of medicines for the rash and pain in his back. Last Wednesday, patient got the vaccination, his second dose and then Thursday he had headache and muscle spasm, Friday he was not feeling right and also he had his lymph node were swollen and then on Saturday he started getting dead skin on his lower left side but he still had and this morning when he look at his skin, he thought rash on his both sides and on his both arm. The patient underwent lab tests and procedures which included platelet count: unknown results. Therapeutic measures were taken as a result of pain on lower left side of back and rash on my both sides and on my both arms. The seriousness of the events was non-serious. The outcome of the event not feeling well, pain on lower left side of back and rash on my both sides and on my both arms was not recovered and all other events was recovered on an unspecified date in Feb2021.  No follow-up attempts are possible; Information on lot number, batch number could not be obtained.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Rash
Clinical narrative: lymph node was swollen; Rash on my both sides and on my both arm; Not feeling well; Pain on lower left side of back; Muscle spasms; Headache; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 71-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry: Unknown, Age at vaccination: 71 years) via an unspecified route of administration on 10Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history was not reported and there were no concomitant medications. The patient previously received bnt162b2 (lot number: E18982 or EL8982, Expiry: Unknown) as dose 1 on 20Jan2021 for COVID-19 immunisation. On 11Feb2021 the patient experienced muscle spasms, headache, on 13Feb2021 the patient experienced not feeling well, pain on lower left side of back, on 17Feb2021 it was reported that rash on my both sides and on my both arm and on unspecified date patient experienced lymph node was swollen. Patient went to see primary care and was prescribed a couple of medicines for the rash and pain in his back. Last Wednesday, patient got the vaccination, his second dose and then Thursday he had headache and muscle spasm, Friday he was not feeling right and also he had his lymph node were swollen and then on Saturday he started getting dead skin on his lower left side but he still had and this morning when he look at his skin, he thought rash on his both sides and on his both arm. The patient underwent lab tests and procedures which included platelet count: unknown results. Therapeutic measures were taken as a result of pain on lower left side of back and rash on my both sides and on my both arms. The seriousness of the events was non-serious. The outcome of the event not feeling well, pain on lower left side of back and rash on my both sides and on my both arms was not recovered and all other events was recovered on an unspecified date in Feb2021.  No follow-up attempts are possible; Information on lot number, batch number could not be obtained.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: Chills; Nausea; Headache; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 30-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3247 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 15Feb2021 at 09:30 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included allergy to arthropod sting. Concomitant medications included fluticasone propionate (FLONAZE) and loratadine (LORATADINE). The patient took dose 1 of bnt162b2 on 26JAN2021 at 09:30 AM for COVID-19 immunization (lot number:EL3247, Vaccine location: Left arm). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced chills, nausea and headache on 15Feb2021 at 20:00. No treatment was received for the events. Outcome of the events chills was recovered on 15FEB2021 (Chills lasted approximately 3 hours), Nausea was recovered on an unknown date in FEB2021, Headache was recovered on 16FEB2021 (lasted until 12:00 PM of the next day).  Follow-up (25Feb2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from contactable consumer. A patient of unspecified age and gender received bnt162b2 (Formulation; Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had both Pfizer vaccines. Nothing but a sore arm after the first one. The outcome of the event was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer via Pfizer sales representative. A 46-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 14Feb2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included ongoing diabetes mellitus. Concomitant medications were not reported.  The patient previously took first dose of BNT162B2 on unspecified date for Covid-19 immunisation. In Feb2021, the patient experienced headache. The headache started about 12 hours after he received the shot. He still has a headache although it is getting better with time. The outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Osteoarthritis
Clinical narrative: osteoarthritis; This is a spontaneous report from contactable consumer via Pfizer Sales Representative. This 74-year-old female consumer (patient) reported that:  A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced osteoarthritis with outcome of unknown. The clinical outcome of event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity, Vaccination site pain
Clinical narrative: Dizziness; major pain at injection site and surrounding area of arm; major pain at injection site and surrounding area of arm; headache; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 51 year old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 16Feb2021 09:30 (Batch/Lot Number: EN5318) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included bupropion (BUPROPION) taken for an unspecified indication, start and stop date were not reported; fluoxetine (FLUOXETINE) taken for an unspecified indication, start and stop date were not reported; trazodone (TRAZODONE) taken for an unspecified indication, start and stop date were not reported; propranolol (PROPANOLOL [PROPRANOLOL]) taken for an unspecified indication, start and stop date were not reported; levofloxacin (LEVO [LEVOFLOXACIN]) taken for an unspecified indication, start and stop date were not reported. The patient previously took levaquin and experienced drug hypersensitivity, amoxicillin and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation. The patient experienced dizziness on 16Feb2021 11:00 with outcome of recovering, major pain at injection site and surrounding area of arm leading to vaccination site pain on 16Feb2021 11:00 with outcome of recovering, major pain at injection site and surrounding area of arm leading to pain in extremity on 16Feb2021 11:00 with outcome of recovering and headache on 16Feb2021 11:00 with outcome of recovering.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A male patient of an unspecified age (reported as Age: 66, unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm after use of product on an unspecified date. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from contactable consumer (patient) via Pfizer Sales Representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, a patient of female 66 had a sore arm after the vaccine on an unspecified date. Stated that, the event took place after use of product. The outcome of the event was unknown.  Information about batch/lot number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Pain in extremity, Vaccination site pain
Clinical narrative: injection site pain; Arm pain; chilly; This is a spontaneous report from a contactable consumer. This consumer reported for a 65-year-old male patient (husband). A 65-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on 15Feb2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced injection site pain, arm pain, chilly on an unspecified date. After the 1st dose, he had arm pain very quickly/right away. After 2nd dose- normal injection site pain only when go midway up and back and touching of injection site". "Arm pain on the same level". Caller says, "He definitely chilly". offered to warm transfer. Outcome of the event was unknown.  Information about lot/Batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Fibrous histiocytoma, Nausea, Oropharyngeal pain
Clinical narrative: sore throat; nausea; injection site redness; dermatofibroma/hardened area under skin; fatigue; confusion; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 02Feb2021 11:00 (Batch/Lot Number: EN9265) as dose 1, single, dose 2 via an unspecified route of administration, administered in Arm Right on 23Feb2021 14:00 (Batch/Lot Number: EN6200) as dose 2, single for covid-19 immunisation (age at vaccination 81 year old). Medical history included congenital heart failure, atrial fibrillation, essential tremor, Known Allergies: PCN, Tetracycline, Erythromycin, Rocephin, sulfa, codeine, ms, demerol from an unknown date and unknown if ongoing. Concomitant medication(s) included propranolol hydrochloride (INDERAL); atorvastatin (ATORVASTATIN); apixaban (ELIQUIS); montelukast sodium (SINGULAIR); duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, start and stop date were not reported. The patient previously took tetracycline and experienced Known Allergies: tetracycline, erythromycin and e Known allergies: Rocephin, rocephin [ceftriaxone] and experienced drug hypersensitivity, codeine and experienced drug hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On unspecified date, the patient experienced sore throat, nausea, injection site redness, dermatofibroma/hardened area under skin, fatigue, confusion. Adverse event: sore throat, nausea, sore arm with reddened area at injection site (2 inches) with hardened area under skin, fatigue, occasional fogginess. No treatment was received. The outcomr for all events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: sore throat; nausea; injection site redness; dermatofibroma/hardened area under skin; fatigue; confusion; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 02Feb2021 11:00 (Batch/Lot Number: EN9265) as dose 1, single, dose 2 via an unspecified route of administration, administered in Arm Right on 23Feb2021 14:00 (Batch/Lot Number: EN6200) as dose 2, single for covid-19 immunisation (age at vaccination 81 year old). Medical history included congenital heart failure, atrial fibrillation, essential tremor, Known Allergies: PCN, Tetracycline, Erythromycin, Rocephin, sulfa, codeine, ms, demerol from an unknown date and unknown if ongoing. Concomitant medication(s) included propranolol hydrochloride (INDERAL); atorvastatin (ATORVASTATIN); apixaban (ELIQUIS); montelukast sodium (SINGULAIR); duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, start and stop date were not reported. The patient previously took tetracycline and experienced Known Allergies: tetracycline, erythromycin and e Known allergies: Rocephin, rocephin [ceftriaxone] and experienced drug hypersensitivity, codeine and experienced drug hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On unspecified date, the patient experienced sore throat, nausea, injection site redness, dermatofibroma/hardened area under skin, fatigue, confusion. Adverse event: sore throat, nausea, sore arm with reddened area at injection site (2 inches) with hardened area under skin, fatigue, occasional fogginess. No treatment was received. The outcomr for all events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Lymphadenopathy
Clinical narrative: I did experience with both doses, I had some swollen lymph node; having blood in her urine; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6201), via an unspecified route of administration on 22Feb2021 (at the age of 45-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) on an unspecified date as dose 1, single for covid-19 immunisation, and experienced swollen lymph nodes. On 24Feb2021, the patient experienced having blood in her urine. On an unspecified date, she had some swollen lymph node. The outcome of blood in urine was not recovered; outcome of swollen lymph nodes was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Decreased appetite, Diarrhoea, Nausea
Clinical narrative: frequent urination; diarrhea; chills; nausea; vomiting; loss of appetite; intermittent chest pain; This is a spontaneous report from a Pfizer sponsored Program. A contactable Consumer reported A 81-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included sarcoidosis from an unknown date and unknown if ongoing. Took their 1st Pfizer vaccine dose on 23Jan2021 for covid immunisation. The patient's concomitant medications were not reported. on 20Feb2021 Caller states, starting on the 20Feb2021, her husband started having frequent urination, chills, diarrhea, nausea, vomiting, loss of appetite and intermittent chest pain. Outcome of the events was unknown No follow up attempts are possible. No further information is expected.