chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: her sister's lymph nodes were swollen for weeks; This is a spontaneous report from a contactable consumer (patient's sister). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as unknown dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's lymph nodes were swollen for weeks on an unspecified date. The outcome of the event was unknown at the time of report.   Information on lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Rash
Clinical narrative: Chills and fever; Chills and Fever/Fever has gotten better went from 103to99; Broke out in rash; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), dose 2 via an unspecified route of administration, administered in right arm on 18May2021 at 08:30 as single dose for covid-19 immunization. Medical history included breast cancer from 19Jun2019. She had surgery in Jul2019, a lumpectomy and they did radiation on her left breast in Sep2019 and Oct2019 then she went into remission. The patient's concomitant medications were not reported. No prior Vaccinations (within 4 weeks). No AE(s) following prior vaccinations. The patient previously received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number: unknown) in right arm on 27Apr2021 at 08:30 (at the of 60-year-old) as single dose for covid-19 immunization. She got the shot on Tuesday. When she got her shot she did not start having a reaction until Thursday night. Then Thursday 20May2021 until 22May2021 not having chills anymore, running low grade fever. She had chills and fever on 20May2021 around 5:00 to 6 in the evening. She clarified that it has not went away she is still having a reaction. Her fever has gotten better went from 103 to 99. She took Tylenol and packed herself in ice. Around midnight she broke out in rash on left breast, abdomen and side. It started Thursday (20May2021). It has continued and is persisting. She has taken Benadryl every six hours and ice packs. She is a breast cancer survivor. She is going try to go to the doctor today because her rash is not going away. A visit to emergency room or physician office was not required. The outcome of the events chills was recovered on 20May2021, fever was recovering; rash was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Blood triglycerides, Lipids, Scan, Therapeutic response unexpected, Vitamin D
Clinical narrative: Lymph node swelling almost completely gone/ , in the past she was also having ear infections but not since the covid vaccines; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 18-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 25Apr2021 (Batch/Lot Number: EW0170) as 2ND DOSE, SINGLE DOSE (at the age of 18-years-old) for covid-19 immunisation. Medical history included, constipation from an unknown date and unknown if ongoing (She did go to the oncologist and they checked everything, nothing was diagnosed), blood cholesterol from an unknown date and unknown if ongoing (had family history)(Her father side has high blood pressure, cardiac problems, and cholesterol), ear infection from an unknown date and was not ongoing, lymphadenopathy from an unknown date and unknown if ongoing (4 years prior to the covid vaccine), premature baby from an unknown date and unknown if ongoing (she is a triplet). There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. No additional vaccines administered on same date of the Pfizer suspect. The patient previously took historical vaccine, first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8735) (at the age of 18-year-old) on 03Apr2021 for covid-19 immunisation and experienced swelling went down (The swelling began to decrease about a week after getting the first dose, it wasn't immediate); Xyzal for Lymph nodes, vitamin D for Low vitamin D (her Vitamin D went back to normal) and TUMS. It was reported that patient mother has thyroid disorder and takes medication for it in the morning. Her father side has high blood pressure, cardiac problems, and cholesterol. The patient had undergone laboratory tests on an unknown date includes Triglycerides resulted in high, lipid panel was high, scan on the lymph nodes which resulted in swelling (the swelling was fine, there was nothing cancerous) Vitamin D resulted in low. The patient had no allergies. The patient lymph node swelling almost completely gone on an unknown date. It was also reported that after the first dose, the swelling went down but not as much, then after the second dose the swelling went down completely, there was still a mini bump, but the swelling was almost completely gone, the mini bump from what it was before was also so much better. Usually in the past she would be inflamed again and again in which it would go down but then come back but since the vaccine it was been down and has not returned. It was also reported that in the past she was also having ear infections but not since the covid vaccines. The patient reported that she was a triplet they are all 18, all 3 of them were born as premature. The patient did not visit to emergency room or physician office. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: a little tired; achy for a day; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry dates were not provided), via an unspecified route of administration, on an unspecified date as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient had very little side effects from the vaccine, just a little tired and achy for a day. The outcome of the events was reported as recovered on an unknown date.  Information on lot/batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report based on information received by Pfizer from Novartis (mfr control no. NVSC2021US110715), report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headaches after her last COVID-19 Vaccine on an unspecified date. Outcome of the event was unknown.  Follow-up needed. Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Slight pain at the injection site; Lowgrade headache; This is a spontaneous report from a contactable consumer (patient) who reported for himself and his wife. This is first of the two reports reported by the consumer (reporter case). A 70-year-old male patient received BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, first dose on 07Jan2021 (Lot Number: EJ1685) and second dose on 07Feb2021 (Lot Number: EN53182) at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The consumer reported that no real side effects were encountered except slight pain at the injection site and low-grade headache that resolved within 24 hours. The outcome of the events was resolved. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021601624 same reporter/drug/AE, different patients
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Slight pain at the injection site; Lowgrade headache; This is a spontaneous report from a contactable consumer (patient spouse) who reported for himself and his wife. This is the second report of the two reports reported by the consumer: the consumer wife.  A 69-year-old female patient received BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, first dose on 07Jan2021 (Lot Number: EJ1685) and second dose on 07Feb2021 (Lot Number: EN53182) at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The consumer reported that no real side effects were encountered except slight pain at the injection site and low-grade headache that resolved within 24 hours. The outcome of the events was resolved. ; Sender's Comments: Linked Report(s) :  same reporter/drug/AE, different patients
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia, Sleep terror
Clinical narrative: Had a really bad night terror; Night terror was a bad night terror that lasted for about 20 minutes to half hour; It was really bad episode of night terror, severe night terror; Fever; Arm was sore; Armpit was sore; Tired; This is a spontaneous report from a contactable consumer (patient mother) reported for a 13-year-old male patient (reporter son). A 13-years-old male patient received BNT162B2 (PFIZER COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0182) via an unspecified route of administration, administered in arm left on an unspecified date at an unknown, single dose for COVID-19 immunization. The patient medical history was not reported. It was reported that NDC number, UPC number and Expiry Date (Reporter stated, They did not write the expiration date) of COVID-19 Vaccine were unknown. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), multivitamins (VITAMINS NOS). Reporter stated, She was just calling because his 13-year-old son got the Pfizer vaccination on Friday at 2:00 pm and she spoke to his pediatrician about it like about 10-20 minutes ago and he told me to contact to you guys because patient experienced had a really bad night terror from it with a fever obviously, his armpit was sore; arm was sore but the night terror was a bad night terror that lasted for about 20 minutes to half hour severe night terror and he was tired, those were the reactions to it on an unspecified date. The patient received tylenol as a treatment medication to the events. The outcome of the events was unknown.  Follow-up attempts needed. Further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: tiredness; headache; chills; Achy; threw up; nausea; This is a spontaneous report from a contactable consumer (patient wife) reported for her husband (patient). This is the report 2 of 2. A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in arm right on 05May2021 at 15:45(at the age of 61-years-old) as a 1st dose, single dose for COVID-19 immunisation. The patient's medical history included high cholesterol, ongoing from an unspecified date, high blood pressure, ongoing from an unspecified date and acid reflux, ongoing from an unspecified date. It was reported that, the patient takes medications for these, but the reporter does not feel these medications are relevant. The patient's concomitant medications were not reported. Patient took Covid-19 vaccine to prevent Covid-19 virus. No other vaccinations within four weeks prior to the vaccination. The history of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Adverse events following prior vaccinations were reported as none. The caller stated that, 14 days after receiving the first Covid-19 vaccine, the patient experienced tiredness, chills, headache, achy, nausea and he threw up when he got to work on 19May2021. Stated that, she does not have her husband's Covid-19 vaccine record card with her at the time of the call. It was reported that, no adverse events required a visit to emergency room or physician office. The relevant lab tests and procedures included were none and no investigation assessment was reported. The outcome of the events was recovering.   Follow up (25May2021): This is a Follow-up spontaneous report from a contactable consumer. This consumer(patient wife) reported for her husband (patient) included RMH, Patient details, outcome details, suspect product details, event details.  Information about batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021599251 same report/drug/AE, different patient
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: tiredness; headache; chills; Achy; threw up; nausea; This is a spontaneous report from a contactable consumer (patient wife) reported for her husband (patient). This is the report 2 of 2. A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in arm right on 05May2021 at 15:45(at the age of 61-years-old) as a 1st dose, single dose for COVID-19 immunisation. The patient's medical history included high cholesterol, ongoing from an unspecified date, high blood pressure, ongoing from an unspecified date and acid reflux, ongoing from an unspecified date. It was reported that, the patient takes medications for these, but the reporter does not feel these medications are relevant. The patient's concomitant medications were not reported. Patient took Covid-19 vaccine to prevent Covid-19 virus. No other vaccinations within four weeks prior to the vaccination. The history of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Adverse events following prior vaccinations were reported as none. The caller stated that, 14 days after receiving the first Covid-19 vaccine, the patient experienced tiredness, chills, headache, achy, nausea and he threw up when he got to work on 19May2021. Stated that, she does not have her husband's Covid-19 vaccine record card with her at the time of the call. It was reported that, no adverse events required a visit to emergency room or physician office. The relevant lab tests and procedures included were none and no investigation assessment was reported. The outcome of the events was recovering.   Follow up (25May2021): This is a Follow-up spontaneous report from a contactable consumer. This consumer(patient wife) reported for her husband (patient) included RMH, Patient details, outcome details, suspect product details, event details.  Information about batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021599251 same report/drug/AE, different patient
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Insomnia, Muscle spasms, Paraesthesia, Tremor
Clinical narrative: Spasms in hands and feet/spasms in his feet was a weird sensation like little explosions going off, like a nerve issue, around feet, toes, and ankles; Both hands went numb; Both hands went numb and were tingling quite a bit and the next day when he woke up it was worse; He is having the tremors around ankles and feet; It is very uncomfortable and has not been able to sleep well because of it.; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0183), via intramuscular route administered in left arm (left shoulder as reported) on 17May2021 (age 46-year-old at time of vaccination) (in noon as reported) as single dose for preventative/COVID-19 immunisation. Medical history included had an allergy to penicillin and that was when he was a child, he thinks he had a rash. He does not know if he was still allergic. Prior Vaccinations (within 4 weeks) were none. Concomitant medications were none. It was reported that the evening after getting the first shot on 17May2021, both hands went numb and were tingling quite a bit and the next day when he woke up it was worse. On the third day after getting the shot he started getting and was still have spasms in hands and feet on 20May2021. The spasms in feet was a weird sensation like little explosions going off, like a nerve issue, around feet, toes, and ankles, stated it was also in his hands but not quite as much in hands. He still has numbness and tingling in hands and fingers. It was worrisome since he was an artist and paints. It is hard to paint with numbness and tingling. The numbness and tingling has stayed the same but there are periods of it getting intense from time to time, it has not subsided. He was hoping it would only last 2 or 3 days. As he was talking, he was having the tremors around ankles and feet in 2021. It was very uncomfortable and had not been able to sleep well because of it in 2021. The spasms are still the same, if anything they have worsened. No treatment received for events. The outcome of events tremor and insomnia was unknown and for remaining events was not recovered.  Follow up needed, further information has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: swelling at the injection site; redness at the injection site; warm at the injection site; Tiredness; Headache; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A 61-years-old female patient received BNT62B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 22May2021, as 2nd dose, single dose (at the age of 61-years-old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included BNT62B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 01May2021 as 1st dose, single dose for covid-19 immunization. On unspecified date of May2021, patient experienced swelling, redness and warm at injection site and stated that she had some tiredness and headache. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Pain in extremity
Clinical narrative: patient experienced bad flushing in her face; her arm was really sore for one day after the 2nd; This is a spontaneous report from a non-contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as second dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as 1st dose, single for COVID-19 immunization. The patient experienced bad flushing in her face which lasted for 30 minutes after the patient got the vaccine and her arm was really sore for one day after the 2nd dose on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported similar events for two patients. This is the second of two reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Not reported), via an unspecified route of administration on 06May2021 as first dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  On 08May2021, the patient felt tired and mentioned it was no big deal. The outcome was unknown for the reported event.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021600184 Same reporter/drug/event , different patient
Sex: U
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: waking up after about hour and hour and half from sleep; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date consumer stated, I already had a reference number on file I did the safety reporting, but I got some information and my family with my mother who is experiencing the same things that I reported as far as the sleep like waking up after about hour and hour and half from sleep and I just wanted to be added it to the record. Consumer stated, No, it is for me but added to file because everybody is telling me like medical people are telling me they have not heard of this happening you know losing sleep and awaken up from sleep after hour and hour and half. I talk to my mother it happening to her she just got the shot 2-3 weeks ago and its happening to mother in-law got the shot couple month back and this happening to me. The safety report has already been filed I just wanted to add to it I wanted to add that my mother is having the same symptoms as me as far as not able to sleep and my mother in-law is also. The outcome of the event was unknown.  Follow-up attempts are needed. further information is expected.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Heart rate, Heart rate increased
Clinical narrative: Rapid heart beat; Chest pain; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 (Batch/Lot Number: EN2613) (at the age of 55-year-old) as 1st dose, single, dose 2 via an unspecified route of administration, administered in Arm Left on 10May2021 (Batch/Lot Number: EN6198) as 2nd dose, single for covid-19 immunisation. Medical history included none. Concomitant medication(s) included zolpidem (ZOLPIDEM) taken for sleep aid, start and stop date were not reported. On an unspecified date in 2021, the patient experienced rapid heart beat and chest pain. No treatment was given for the events. The outcome of the events was unknown.  Follow-up attempts are needed. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Pyrexia
Clinical narrative: Headache; Fever; strong pain in the chest; This is a spontaneous report from a contactable consumer (patient's mother). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number unknown) via an unspecified route of administration on 24May2021 as 2nd dose, single (at the age of 18-years-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no effects, but patient went to bed early at 20:00 last night and did not mention anything. On 24May2021, patient experienced headache, fever, strong pain in the chest. Patient still felt pain in chest. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal paraesthesia
Clinical narrative: Tingling in throat; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date the patient experienced tingling in throat. The outcome of the event was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Myalgia, Vaccination site pain
Clinical narrative: Pain/soreness at injection site (upper left arm); muscle aches; tiredness; feeling unwell; This is a spontaneous report from a contactable consumer (Patient). A 49-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0187), via an unspecified route of administration in left arm on 24May2021 at 18:15 PM as a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included ibuprofen, famotidine, cetirizine hydrochloride (ZYRTEC), melatonin, paracetamol (TYLENOL): all for an unspecified indication and start and stop dates were not reported. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0176), via an unspecified route of administration in left arm on 03May2021 18:15pm as single dose for COVID-19 immunization. Patient previously took diphenhydramine hydrochloride (BENADRYL) and bupropion hydrochloride (WELLBUTRIN); had allergy with both drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Pain/soreness at injection site (upper left arm), muscle aches, tiredness and feeling unwell on 24May2021 at 20:00 PM. The events were assessed as non-serious. The treatment was not received for the events. The outcome of the events was reported as recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: she developed a cold about four days ago and then received the COVID vaccine and now she feels worse; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (COVID Vaccine, Formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history included cold about four days before vaccination. The patient concomitant medications were not reported. On an unspecified date the patient reported she developed a cold about four days ago and then received the COVID vaccine and now she feels worse. The outcome of the event was unknown.  Additional Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from a contactable consumer (reporting on self). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0175 and Expiration Date was not reported) via an un-specified route of administration on 18May2021, as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously patient took first dose of BNT162B2 (Lot Number:ER8735) on 23Apr2021. Patient got her/his last one on 18May2021 and everyday since then he/she have had a headache and sometime during the day he/she have a really severe headache. Patient want to know if that was normal or not. Will it go away and if that's a normal symptom.  Patient do not know what you mean by that. He/she reporting that he/she having headaches every day since he/she got the second shot. The outcome of the event was unknow.   Information on Lot/Batch number was available. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from a contactable consumer reported for a patient as per the FDA Guidelines for Post marketing Reporting of Adverse Drug Reactions (Docket No. 85D-0249) dated Mar1992 (Part VI, I).   A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: not reported), via an unspecified route on an unknown date as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache. It was unknown if the patient received any treatment for the events. The clinical outcome of the event headache was reported as unknown.  Follow-up needed. Information about batch/lot number has been requested.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Migraine, Somnolence
Clinical narrative: I don't really like how my body felt; Migraine headache; I was like tired and drowsy; I was like tired and drowsy; This is a spontaneous report received from a contactable consumer or other non hcp (patient, self-reporting).   A 38-years-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0173 and expiration date was not reported), via an unspecified route of administration on 05May2021 as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included iron; ergocalciferol (VITAMIN D); amlodipine besilate taken for an unspecified indication, start and stop date were not reported. On 05May2021 the patient stated that, have a quick question patient son was 18 and they both were scheduled to Pfizer 2 vaccine on Wednesday and patient concern was when son got Pfizer vaccine, he was fine. When patient got, for about four days patient had Migraine headache and was like tired and drowsy, patient don't really like how body felt, it took a while for headache to go away, like it was like light migraine and patient was taking Tylenol and have to get the second vaccine, but patient thinking may be going to have same type of side effect and little bit worried about it, patient son was fine. Outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Pain in extremity
Clinical narrative: Could not walk; Feet hurt; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number, expiry date and NDC number were not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history, investigation assessment, concomitant medications and other products were not reported. Historical vaccine included first dose of BNT162B2 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. As per the description, the caller mentioned that a friend, who has a sister living in another state received the second shot of Pfizer Covid-19 vaccine and experienced feet hurt and she couldn't walk. Caller confirmed that the effects lasted a couple of days. The outcome of all events was recoveredon an unspecified date.  Information about batch/lot number has been requested.
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Feeling abnormal, Hypoaesthesia, Malaise, Pain
Clinical narrative: My right hand is sleeping in the finger and stays like that this whole time; my hand like numb; My neck little warm like swelling and then in my legs got the same swelling; My neck little warm like swelling and then in my legs got the same swelling; It was very painful very sensitive; It like my ganglia are swelling; In my face in my right side like a little bump; The second shot felt very bad; It is very hard to work with these side effects; It scares me a little bit because I don't feel good and strong / feeling sick; my ganglia are swelling; This is a spontaneous report from a contactable consumer (patient). A 49-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0185, UPC/ NDC number / Expiry Date of COVID Vaccine: Unknown), via an unspecified route of administration on 12May2021 (at the age of 49 years) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included headache, fever, tired and feeling sick; all were from an unknown date and unknown if ongoing. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Batch/Lot Number: EBK33) on 02Apr2021 for covid-19 immunisation. It was reported as, the patient was called because I have the Pfizer Vaccine (COVID Vaccine) the second shot and 10 days ago patient right hand was sleeping in the finger and stays like that this whole time. The patient doesn't know you have any side effect like that with another person, patient know everybody was different. The concern in patient hand was sleeping like my fingers and little bit my hand like numb. The patient had the headache, fever and patient was so tired after getting the first shot, for next sixteen hours patient was feeling sick and then patient took Tylenol, and everything was perfect. After the second vaccine on 12May2021, the patient started feeling my hand numb and then the other side effect was patient neck got little warm like swelling and then patient legs got the same swelling. The patient have to take medication for the pain, because it was very painful very sensitive. It like my ganglia are swelling. In my face in my right side like a little bump but no acne. Patient don't know if there are more people like me with the side effect because I went to emergency room I was there for 5 hour on 16May2021, because in patient legs and all this I think it is related to patient heart but everything was okay. The second shot felt very bad. It is very hard to work with these side effects. It scares the patient a little bit because patient don't feel good and strong. The patient feeling sick." consumer stated on Lab work as, "They did blood test in the emergency room like on 16May 2021. I don't have the results, but everything was okay." Therapeutic measures were taken as a result of events with Just Ibuprofen (as reported). Outcome of the events was unknown.  Further information has been requested.
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Skin disorder, Swelling, Synovial cyst
Clinical narrative: My right hand is sleeping in the finger and stays like that this whole time; my hand like numb; My neck little warm like swelling and then in my legs got the same swelling; My neck little warm like swelling and then in my legs got the same swelling; It was very painful very sensitive; It like my ganglia are swelling; In my face in my right side like a little bump; The second shot felt very bad; It is very hard to work with these side effects; It scares me a little bit because I don't feel good and strong / feeling sick; my ganglia are swelling; This is a spontaneous report from a contactable consumer (patient). A 49-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0185, UPC/ NDC number / Expiry Date of COVID Vaccine: Unknown), via an unspecified route of administration on 12May2021 (at the age of 49 years) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included headache, fever, tired and feeling sick; all were from an unknown date and unknown if ongoing. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Batch/Lot Number: EBK33) on 02Apr2021 for covid-19 immunisation. It was reported as, the patient was called because I have the Pfizer Vaccine (COVID Vaccine) the second shot and 10 days ago patient right hand was sleeping in the finger and stays like that this whole time. The patient doesn't know you have any side effect like that with another person, patient know everybody was different. The concern in patient hand was sleeping like my fingers and little bit my hand like numb. The patient had the headache, fever and patient was so tired after getting the first shot, for next sixteen hours patient was feeling sick and then patient took Tylenol, and everything was perfect. After the second vaccine on 12May2021, the patient started feeling my hand numb and then the other side effect was patient neck got little warm like swelling and then patient legs got the same swelling. The patient have to take medication for the pain, because it was very painful very sensitive. It like my ganglia are swelling. In my face in my right side like a little bump but no acne. Patient don't know if there are more people like me with the side effect because I went to emergency room I was there for 5 hour on 16May2021, because in patient legs and all this I think it is related to patient heart but everything was okay. The second shot felt very bad. It is very hard to work with these side effects. It scares the patient a little bit because patient don't feel good and strong. The patient feeling sick." consumer stated on Lab work as, "They did blood test in the emergency room like on 16May 2021. I don't have the results, but everything was okay." Therapeutic measures were taken as a result of events with Just Ibuprofen (as reported). Outcome of the events was unknown.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Hands fell asleep; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient of unknown age who received BNT162B2 (COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date her hands fell asleep. The outcome of event was unknown. Information on Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Cyanosis
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose and also received second dose of BNT162B2 (COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient reported having blue hands after receiving both doses of the covid vaccine. The outcome of the event was unknown. Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: This is a spontaneous report from a non-contactable consumer via a sales representative. A female patient of an unspecified age received BNT162B2 (COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose in arm, single dose for covid-19 immunisation. The patient medical history and concomitant medication were not reported. The patient experienced the arm that she received the shot on felt tingly and weak for a few days on an unspecified date. Outcome of the events were recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a COVID- sponsored program via a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she was happy and only got a sore arm after her first dose on an unspecified date. The outcome of the event was unknown at the time of report. Information about the lot/batch number has been requested.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Feeling numbness in nose; numbness in forehead; This is a spontaneous report was received from a contactable consumer or other non hcp (patient's mother). A 12-years-old female patient of weight 40.816 kilograms and height 147 centimetres received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0175; Expiration Date: 31Aug2021), via an unspecified route of administration on 23May2021 as 1st dose, single dose for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included vitamin D no's (VITAMIN D) and elderberries. The patient's mother reported that her daughter who was 12 she had COVID Vaccine on Sunday and on 24May2021, she was feeling numbness in her nose. She felt numbness in her forehead but that went away, but her nose was still numb. She knew she read through the symptoms and that was not one of them, so she was just wondering if it was like allergic reactions or was that part of the symptoms. The patient was treated with Tylenol and Ibuprofen. The patient is going to get the second dose of vaccination on 13Jun2021. On an unspecified date in 2021, the patient had recovered from numbness on the forehead and was not recovered from numbness on the nose.   Information on Lot/Batch number was available. Additional information has been requested.   Follow-up attempts are possible. Further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Headache
Clinical narrative: headache; diarrhea; stomach ache; tired; This is a spontaneous report from a contactable consumer (patient's mother) via medical information team. A 13-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0182), via an unspecified route of administration in Arm Left on 25May2021 at 13:00 (13-years-old at the time of vaccination) as single dose for COVID-19 immunization. The patient's medical history included mental problem (reported that she takes a medicine for a mental problem that she has but the caller does not know the name of the medication or the condition). The patient had no family medical history relevant to adverse events. The patient did not receive other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient's concomitant medications were not reported. The patient's weight is 200 something. On 25May2021, the patient experienced headache, diarrhea, stomach-ache and was tired. Clinical course included: headache began after the shot yesterday (25May2021); diarrhea and stomach-ache began last night. Her daughter was also tired, she just said she was going to go take a nap now. The tiredness also started yesterday because she laid down with the headache, so it had to be yesterday. The tiredness was persisting about the same, caller's spouse can be heard in the background of the call saying everything was persisting about the same. The outcome of events was not recovered.  Additional information is requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) via sponsored program support. A 22-years-old female patient received bnt162b2 (COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 23May2021 (at the age of 22-years-old) (Batch/Lot number: Not reported) as 1st dose single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fatigue. Patient wanted to know for how long she should expect to experience this side effect and also asked if she should go see a doctor or wait for a couple of days for the side effects to disappear. Outcome of the events was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: This is a spontaneous report from a sponsored program from a contactable consumer (patient) via feedback. A female patient of an unspecified age received bnt162b2 (COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was experiencing increasing blood pressure problems. Patient was inquired that if there was anything that could be done to relieve this problem after the vaccine. Patient had been to the doctor and received a increase, but blood pressure problems still not stable. The outcome of the event was not resolved. Information on the lot/batch number has been requested.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Dysphagia, Mouth ulceration
Clinical narrative: difficulty swallowing; mouth ulcers; This is a spontaneous report from a contactable consumer via medical information team. A 17-year-old patient of an unspecified gender received bnt162b2 (Solution for injection), via an unspecified route of administration on an unspecified date (at the age of 17-years-old) as 1st dose, single dose for covid-19 immunisation. Medical history included peanut allergy. The patient's concomitant medications were not reported. On an unknown date, the patient experienced difficulty swallowing and mouth ulcers after received first dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Pityriasis rosea, Rash, Viral infection
Clinical narrative: the rash started about 2 - 7 days after the vaccination; probably related to a viral infection. Said it looks like pityriasis rosea; probably related to a viral infection. Said it looks like pityriasis rosea; This is a spontaneous report from a non-contactable consumer (parent) reported for a 13-year-old (same age during vaccination) male patient (son) that patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on 15May2021 as single dose for COVID-19 immunisation. Patient s medical history and concomitant medications were not reported. Caller's son received the first dose of the Pfizer vaccine on 15May2021. Rash occurred a week later. Caller stated the rash started about 2 - 7 days after the vaccination. Caller stated, they went to the pediatrician, they think this may not be caused by the vaccine, probably related to a viral infection. Said it looked like pityriasis rosea. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained