chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Migraine
Clinical narrative: Massive migraine; since this morning and it's not going away, at the front of my forehead, it moves to my right side temple, my left side temple, its all concentrated around that temple; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Lot number: FC3183) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "Pacemaker" (unspecified if ongoing), notes: have a pacemaker also. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 immunization. The following information was reported: MIGRAINE (non-serious) with onset 04Oct2021, outcome "not recovered", described as "Massive migraine; since this morning and it's not going away, at the front of my forehead, it moves to my right side temple, my left side temple, its all concentrated around that temple". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine.  Additional information: I have since this morning and it's not going away it's like a massive migraine but it's all its kind at the front of my forehead but rest of it is, all located, it moves to my right side temple. I mean, my left side temple, it's all concentrated around that side and around that temple. Is that something that is going on with the Pfizer vaccine or is it not here? Something else that I should report to ER for. Consumer stated, "I did, I actually don't have it handy. Doctors haven't called me on that yet. I just had it done on Friday. Treatment: No, just Ibuprofen.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatigue".  Additional information: It was reported that Caller received second dose of the Pfizer BioNTech Covid 19 vaccine on 26Feb2021.  After her first vaccine she just experienced a headache and was fatigued for a few days.  After her second dose, she had headaches and a sore arm, her lymph nodes in her arms swelled up, had a fever for a couple of days and couldn't really concentrate.  In Feb2019 she was in a car accident and had a traumatic brain injury/concussion.  The synapses around her brain were injured causing numbness.  After getting the second vaccine, she said it felt like her car accident all over again with the numbness.  This side effect lasted about a month. Five to six weeks after the second dose, she got bloodwork done for the cardiologist and he called her and asked what she had been doing, that all of her enzymes were all elevated, liver, pancreas, everything.  She hadn't done anything differently in that time period other than get the vaccine.  Her husband had all three shots and had virtually no side effects other than fatigue. She is calling to see if these side effects were caused by the vaccine. What is the probability that a rise in enzymes would happen again. Should she get the third dose of the vaccine. Follow-up attempts completed. No further information is expected.  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: Chills, Fatigue, Feeling hot, Illness, Nausea
Clinical narrative: woke up this morning throwing up (nauseous); got really hot all over her entire body; had chills through the night off and on; tired; getting sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Sep2021 (Lot number: 3014589) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "blood pressure" (unspecified if ongoing), notes: she had the symptoms before. Concomitant medication(s) included: AMLODIPINE BENAZEPRIL taken for blood pressure measurement. Vaccination history included: Bnt162b2 (Dose: 1, Lot number EN6202), administration date: 26Feb2021, when the patient was 74 years old, for Covid-19 Immunization; Bnt162b2 (Dose:2), administration date: 20Mar2021, when the patient was 74 years old, for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 30Sep2021, outcome "recovered with sequelae" (01Oct2021), described as "had chills through the night off and on"; FATIGUE (non-serious) with onset 30Sep2021, outcome "recovering", described as "tired"; NAUSEA (non-serious) with onset 01Oct2021, outcome "recovered" (01Oct2021), described as "woke up this morning throwing up (nauseous)"; FEELING HOT (non-serious) with onset 01Oct2021, outcome "recovered" (01Oct2021), described as "got really hot all over her entire body"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "getting sick".  Additional Information: Patient is 75 years, 11 months. Patient wanted to report how she ended up getting sick. Stated that she got really hot all over entire body. Stated that she had chills through the night on and off and felt nauseous. Stated that she woke up this morning and ended up throwing up. Stated that she took her blood pressure pill that she decided not to retake and then threw up. Stated that she had taken Amlopidine Benazapril. Stated that she had the symptoms before and took it because it controls her blood pressure. Stated that she took the anti-Covid shot yesterday. Clarified that it is the Covid 19 shot. Stated that this is her third shot. Stated that from 12:30am until 5am or 6am that she felt really hot all over her entire body. Stated that 1.5 hours later that she was able to eat. Stated that she started taking it years ago. Stated that it is 5/20mg. Stated that the lot could be 3014S8A for the third shot. Stated that the lot for the first shot was EN6202 on 26Feb2021. Stated that the lot for the second shot on 20Mar2021 is for Pfizer BioTech is not listed.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Tenderness, Vaccination site pain
Clinical narrative: The caller's mother said that she had arm pain this morning but it is only when she touches it that she feels it; a little bit of a sore arm; feel sleepy after the COVID vaccine, like drunk sleepy, and she dose feel sleepy now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP)(patient's daughter).  A 84 year-old female patient received bnt162b2 (BNT162B2), administration date 30Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 30Sep2021, outcome "recovering", described as "a little bit of a sore arm"; SOMNOLENCE (non-serious) with onset 30Sep2021, outcome "not recovered", described as "feel sleepy after the COVID vaccine, like drunk sleepy, and she dose feel sleepy now"; TENDERNESS (non-serious) with onset 01Oct2021, outcome "unknown", described as "The caller's mother said that she had arm pain this morning but it is only when she touches it that she feels it".  Additional information: Investigation Assessment was no. Reporter inquired if her mother had side effects as well since she mentioned reporting on her and the caller states that her mother went walking yesterday to the pharmacy and was wearing her mask and it was hot weather. Her mother said that she has a little bit of a sore arm but has had no diarrhea. She did feel sleepy after the COVID vaccine, like drunk sleepy, and she dose feel sleepy now but she wass glad that she got it. The thing is the caller's mother's brother got the vaccine and he is 82-years-old and the caller doesn't think that he had any side effects at all. He had his done two weeks ago and his wife also got it and had no side effects. They both did the boosters because they had to fly. Primary/ Prescribing Healthcare Professional Info was not probed since caller stated that she did not want to provide specific patient information. reporter's mother still had a sore arm. The sore arm started a little bit yesterday, 30Sep2021, but she felt it more today but now it is going away. The caller's mother said that she had arm pain this morning but it is only when she touches it that she feels it. She also did not bleed after having the COVID vaccine. The reporter was probed for NDC, lot number and expiry date and caller declined to provide and states that her mother also got this done at #.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient developed arthralgia (had the hip pains/joint pains), with outcome of unknown. Additional information: Reporter stated his girlfriend had hip and joint pains from taking the vaccine. He confirmed vaccine she took was the Pfizer COVID-19 vaccine. Reporter stated he will have her call, that way she can answer additional questions. Batch/lot number not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: felt pretty bad for a day or two; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt pretty bad for a day or two".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (08Nov2021):This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Caller states that it has really been rough on them, especially her husband. Caller repeats that it has been really hard on the body.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 02Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose.), for COVID-19 immunization; Bnt162b2 (Second dose.), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 02Oct2021, outcome "unknown", described as "Caller states that it has really been rough on them, especially her husband. Caller repeats that it has been really hard on the body.".  Follow-up (15Nov2021)This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Second dose: light headed; Second dose: tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 75 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 09:30 (Lot number: EN6204, Expiration Date: Jun2021) at the age of 75 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (ongoing); "COPD", start date: 2007 (ongoing), notes: Verbatim: COPD. Concomitant medication(s) included: LOSARTAN taken for hypertension (ongoing). Vaccination history included: Bnt162b2 (dose 1 single, Lot: EN6203, Expiration: Jun2021, Route of administration: Left arm , Time the Vaccination Was Given: Noon), administration date: 26Feb2021, when the patient was 74 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset Mar2021, outcome "not recovered", described as "Second dose: light headed"; FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "Second dose: tired".  Additional information included: The report was related to a study or programme. Patient was diagnosed with high blood pressure 10 years ago and started taking Losartan 10 years ago. Investigation Assessment: No. When the caller received the second dose Pfizer Covid Vaccine the caller was light headed and tired for about one or two days. Time the Vaccination Was Given as second dose: in morning about 09:00 09:30. Family Medical History Relevant to AE(s): No. Relevant Tests: none.   No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: a little bit tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 (Lot number: EN6201) at the age of 77 years as dose 2, single and administered in arm left, administration date 04Feb2021 (Lot number: EN5318) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "a little bit tired". Additional information: she responds that she is 78 and she already had her first 2 shots back in February, so she went to her local drug store and both her and her husband got their booster shots. She is calling because she figured Pfizer needed to know the side effects people get. She figured that's how Pfizer gets their data. She states it's not a real serious situation, she had no effect on the first and second one, but the booster dose kind of affected her. The caller states the first two shots her and her husband got were back in February. The only effect she had was that she was a little bit tired, but it was for a day. No additional Vaccines Administered on Same Date of the Pfizer. No prior vaccination within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Lot number: EN6202) at the age of 65 years as dose 1, single and administration date 26Mar2021 (Lot number: ER8730) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: UNITHROID. Vaccination history included: Shingrex (The caller had both doses of Shingrex and the Pneumonia vaccine at the beginning of the year but didn't have any reactions to them.), administration date: 2021; Pneumonia vaccine (The caller had both doses of Shingrex and the Pneumonia vaccine at the beginning of the year but didn't have any reactions to them.), administration date: 2021. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm".  Additional information: The caller had her third shot on Thursday, 30Sep2021, and she didn't have any side effects except that evening she had a sore arm in that area where she had the vaccine. The caller had a sore arm with the first and second shot. 01Oct2021 the caller started having some pain in the left chest area. Saturday morning the caller's arm was better. The chest pain has been consistent and is better today. The caller's chest pain was consistent Saturday and Sunday. Sunday morning the caller could feel a pressure on the left side of her chest. This morning the caller's chest feels better but she hasn't been that active. With the first and second doses the caller was fine during the day and then when she was going to bed her arm was sore. Throughout the evening it was sore and then it cleared up within 24 hours after the shot. The caller had an abscessed tooth on the first week in Sep2021 and had to take antibiotics after that. The last visit for the caller's abscessed tooth was 13Sep2021 and two weeks prior to that the caller was put on 4 different things. The caller was given Clindamycin HCL 300 mg capsule, ibuprofen, Methylprednisolone, and Hydrocodone-acetaminophen. The caller had the root canal on 13Sep2021 but she was put on these medications two weeks prior to that procedure. The caller began taking these products on 30Aug2021. Vaccination Facility Type was Pharmacy.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administration date 05Feb2021 (Lot number: EL9261) at the age of 76 years as dose 1, single and administration date 26Feb2021 (Lot number: EN6200) as dose 2, single for covid-19 immunisation. Relevant medical history included: "she takes her thyroid and cholesterol medications" (unspecified if ongoing); "she takes her thyroid and cholesterol medications" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Additional information: Reporter seriousness for first and second dose: sore arm: Unspecified. The patient received all three of her Covid 19 vaccines at the Clinic site. She was thinking about getting the flu vaccine in a couple weeks. She was asking if anyone else is having the same reaction as her. The patient did not received any other Prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s). The patient did not have any AE(s) following prior vaccinations and no Medical History (including any illness at time of vaccination) No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program. A 65 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SHINGRIX. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "his hands hurting a little more". Additional Information: Patient reported he was not taking xeljanz 1 week before and 1 week after receiving vaccinations (Covid 2 doses, Shingrix 1 dose). No dates were given for vaccinations. Patient stated that during that time noticed his hands hurting a little more. No details were given about duration or intensity of pain at that time. No further details given. Physician was aware. The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up. The lot/batch number was not available despite the follow-up attempts made. Follow-up attempts completed. No further information was expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Photopsia, Vision blurred
Clinical narrative: I began having flashes on the left side of the left eye one day ago. Today, I continue to have the flashes; I cannot focus either eye (vertical double vision).; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Oct2021 10:45 (Lot number: FF2587) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "depression" (unspecified if ongoing); "cancer", start date: 2013 (unspecified if ongoing), notes: cancer (2013); "Allergy: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE; VENLAFAXINE; LOSARTAN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EO6955, Location of injection: Arm Right, Vaccine Administration Time: 04:00 PM), administration date: 20Mar2021, when the patient was 55 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Left, Vaccine Administration Time: 11:30 AM), administration date: 27Feb2021, when the patient was 55 years old, for COVID-19 Immunization. The patient was no diagnosed with COVID-19 prior and since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: PHOTOPSIA (non-serious) with onset 04Oct2021 07:00, outcome "not recovered", described as "I began having flashes on the left side of the left eye one day ago. Today, I continue to have the flashes"; VISION BLURRED (non-serious) with onset 04Oct2021 07:00, outcome "not recovered", described as "I cannot focus either eye (vertical double vision).". Therapeutic measures were not taken as a result of photopsia, vision blurred. No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Painful lymphadenopathy; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Oct2021 (Lot number: 301458A) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL0142, Location of injection: Arm Left), administration date: 11Jan2021, for covid-19 immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: EH9899, Location of injection: Arm Left), administration date: 21Dec2020, for covid-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 04Oct2021 01:00, outcome "not recovered", described as "Painful lymphadenopathy". Therapeutic measures were not taken as a result of lymphadenopathy. Additional information: : Painful lymphadenopathy beginning in the left axilla about 12-18 hours after injection. By 24-36 hours after injection the painful adenopathy spread to the left supraclavicular lymph nodes. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Lymphadenopathy, Vaccination site erythema, Vaccination site inflammation
Clinical narrative: Injection site red; Injection site inflamed; Injection site hard; Lymph node swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Oct2021 16:15 (Lot number: Ff8839) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: En6293, Location of injection: Arm Left), administration date: 01Mar2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EM9809, Location of injection: Arm Left), administration date: 08Feb2021, for COVID-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 03Oct2021, outcome "recovering", described as "Injection site red"; VACCINATION SITE INFLAMMATION (non-serious) with onset 03Oct2021, outcome "recovering", described as "Injection site inflamed"; INJECTION SITE INDURATION (non-serious) with onset 03Oct2021, outcome "recovering", described as "Injection site hard"; LYMPHADENOPATHY (non-serious) with onset 03Oct2021, outcome "recovering", described as "Lymph node swollen". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site inflammation, injection site induration, lymphadenopathy.  Additional information: Facility where the most recent COVID-19 vaccine administered was pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Extrasystoles
Clinical narrative: Ectopic Heart Beats; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Dec2020 09:00 (Lot number: EK5730) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gastrooesophageal reflux disease" (unspecified if ongoing). Concomitant medication(s) included: PROTONIX [OMEPRAZOLE]. Past drug history included: Latex, reaction(s): "Allergy". The following information was reported: EXTRASYSTOLES (non-serious) with onset 17Dec2020 20:00, outcome "not recovered", described as "Ectopic Heart Beats". The event "ectopic heart beats" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of extrasystoles.  Additional information: Additional information: The patient received Dose 2 single, administered in arm left, administration date 08Jan2021 .The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine, and Prior to vaccination. Prior to vaccination patient was not diagnosed with COVID-19, and Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Product expiration date issue
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT EXPIRATION DATE ISSUE (non-serious), outcome "unknown", described as "She states that the first 2 Covid vaccines there is no expiration date and wants to know why". Verbatim and Event Description: Swap from FC - first time caller/consumer is calling about Covid she received her booster Covid today and states that on the vaccine card shows expired 31Jan2021 and she states that the first 2 Covid there is no expiration date and wants to know why. She also asked how long does this vaccine stay in your system for. She states this time there was a little bit of blood on the bandaid where last 2 times there was no blood at all and what does this mean. She declined her mailing address. Provided number and transferred to PMI hold que. Faxing potential AE to Pfizer. Medical Information (MI): Were any unaddressed medical questions referred or forwarded to Medical Information: Yes. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Follow-up (13Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected. Follow-up (13Oct2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported in response to non-HCP letter sent via telephonic follow-up activity which included that: Consumer Follow-up Questionnaire: Any additional information: Phone Out 4:31 PM EST, 1st attempt by phone to consumer to obtain mailing information. Phone answered by consumer who does not want to continue with the follow up process with the team. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Allergy: Erythromycin"; Morphine, reaction(s): "Allergy: Morphine". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional information: The reporter stated that she was sick after the first 2 Pfizer BT Covid vaccine doses and no allergic reactions. The reporter stated that she was signing up for the Pfizer BT Covid booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Chills; Aches/aches and pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77 year-old female patient received bnt162b2 (COMIRNATY), administration date 04Oct2021 (Batch/Lot number: unknown) at the age of 77 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "tiredness"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "tiredness". The following information was reported: CHILLS (non-serious) with onset Oct2021, outcome "unknown", described as "Chills"; PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "Aches/aches and pain".  Additional information :Patient is very achy and just would like to take either Advil, Tylenol, or Aspirin for the aches and pain. States her doctor is in PRIVACY and she is presently in PRIVACY . Wants to know is there a protocol on what pills she can take when achy in general, what pain reliever can she take.  Follow-up attempts completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Malaise, Pain, Pain in extremity
Clinical narrative: not only was her arm sore but most of her left torso; not only was her arm sore but most of her left torso; She started vomiting right as she was about to enter car; sick; Fatigue; Not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Oct2021 15:45 (Lot number: FC3182) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9261, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 24Jan2021, when the patient was 37 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9267, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 14Feb2021, when the patient was 37 years old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN (non-serious) all with onset 05Oct2021 07:00, outcome "recovering" and all described as "not only was her arm sore but most of her left torso"; VOMITING (non-serious) with onset 05Oct2021 07:00, outcome "recovered" (06Oct2021), described as "She started vomiting right as she was about to enter car"; ILLNESS (non-serious) with onset 05Oct2021 07:00, outcome "recovering", described as "sick"; FATIGUE (non-serious) with onset 05Oct2021, outcome "recovered" (2021), described as "Fatigue"; MALAISE (non-serious) with onset 05Oct2021, outcome "recovered" (06Oct2021), described as "Not feeling well". Therapeutic measures were taken as a result of pain in extremity, pain. Therapeutic measures were not taken as a result of vomiting, illness, fatigue.  Additional information: woke up the morning after her booster (3rd) shot. She mentioned not only was her arm sore but most of her left torso. She took 3 Advil and proceeded to get ready to leave for work (about 7:20 AM). She started vomiting right as she was about to enter car. After about 5 minutes of vomiting, she decided to call in sick instead to work and is resting now. she was not feeling well put attempted to go to work. she began vomiting for about 10 minutes and spends day in bed. Following day, she was fine. Patient took 3 Advil for the adverse events pain and pain in extremity. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications within 2 weeks of vaccination. Patient has not been diagnosed with COVID-19 prior to and since the vaccination. No specific relevant tests for thromboembolic events with thrombocytopenia were carried out.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: not only was her arm sore but most of her left torso; not only was her arm sore but most of her left torso; She started vomiting right as she was about to enter car; sick; Fatigue; Not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Oct2021 15:45 (Lot number: FC3182) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9261, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 24Jan2021, when the patient was 37 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9267, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 14Feb2021, when the patient was 37 years old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN (non-serious) all with onset 05Oct2021 07:00, outcome "recovering" and all described as "not only was her arm sore but most of her left torso"; VOMITING (non-serious) with onset 05Oct2021 07:00, outcome "recovered" (06Oct2021), described as "She started vomiting right as she was about to enter car"; ILLNESS (non-serious) with onset 05Oct2021 07:00, outcome "recovering", described as "sick"; FATIGUE (non-serious) with onset 05Oct2021, outcome "recovered" (2021), described as "Fatigue"; MALAISE (non-serious) with onset 05Oct2021, outcome "recovered" (06Oct2021), described as "Not feeling well". Therapeutic measures were taken as a result of pain in extremity, pain. Therapeutic measures were not taken as a result of vomiting, illness, fatigue.  Additional information: woke up the morning after her booster (3rd) shot. She mentioned not only was her arm sore but most of her left torso. She took 3 Advil and proceeded to get ready to leave for work (about 7:20 AM). She started vomiting right as she was about to enter car. After about 5 minutes of vomiting, she decided to call in sick instead to work and is resting now. she was not feeling well put attempted to go to work. she began vomiting for about 10 minutes and spends day in bed. Following day, she was fine. Patient took 3 Advil for the adverse events pain and pain in extremity. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications within 2 weeks of vaccination. Patient has not been diagnosed with COVID-19 prior to and since the vaccination. No specific relevant tests for thromboembolic events with thrombocytopenia were carried out.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Fatigue; Sharp pulsating pains in lower right leg.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Sep2021 10:00 (Lot number: 301458A) at the age of 54 years for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Pfizer (Dose Number: 1, Batch/Lot No: 301308A, Location of injection: Arm Left), administration date: 01Sep2021. The following information was reported: FATIGUE (non-serious) with onset 29Sep2021, outcome "recovering", described as "Fatigue"; PAIN IN EXTREMITY (non-serious) with onset 29Sep2021, outcome "recovering", described as "Sharp pulsating pains in lower right leg.". Therapeutic measures were not taken as a result of fatigue, pain in extremity. No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 77-year-old female patient received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown); both single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient developed fatigue (first and second dose, felt tiredness), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: I had been having problem with my arm; it hurt but it had gone away; from my arm, elbow to my shoulder the whole joint you know, just pain, really bad pain; I am getting pins and needles in my fingers; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Sep2021 (Lot number: EW0191, Expiration Date: 31Dec2021) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Psoriasis " (ongoing), notes: Onset date: 20 Years ago. Concomitant medication(s) included: VITAMIN D (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 22Sep2021, outcome "not recovered", described as "I had been having problem with my arm; it hurt but it had gone away; from my arm, elbow to my shoulder the whole joint you know, just pain, really bad pain"; PARAESTHESIA (non-serious) with onset 22Sep2021, outcome "not recovered", described as "I am getting pins and needles in my fingers". The events "i had been having problem with my arm; it hurt but it had gone away; from my arm, elbow to my shoulder the whole joint you know, just pain, really bad pain" and "i am getting pins and needles in my fingers" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, paraesthesia.  Additional information: Patient took Motrin as treatment received. Patient was not diagnosed with any prior vaccination (4 weeks prior). The patient was provided with information to you reported adverse event(s) with the use of the product.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: sore arm; general malaise; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (167798). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm"; MALAISE (non-serious) with onset 2021, outcome "recovered" (2021), described as "general malaise".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen, painful node above my left collarbone; Swollen, painful node above my left collarbone; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jul2021 18:00 (Lot number: Ew0198) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 24Jul2021, outcome "not recovered" and all described as "Swollen, painful node above my left collarbone". The event "swollen, painful node above my left collarbone" and "swollen, painful node above my left collarbone" was evaluated at the physician office visit. Therapeutic measures were taken as a result of lymphadenopathy, lymph node pain.  Follow-Up (12Oct2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a sore arm after receiving her COVID 19 vaccine booster shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 immunization; Bnt162b2 (2nd Dose), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "a sore arm after receiving her COVID 19 vaccine booster shot". Additional information: Patient reports a sore arm after receiving her COVID 19 vaccine booster shot. It was better now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hair growth abnormal
Clinical narrative: noticed very sparse axillary hair growth on the side vaccine was administered.; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administered in arm, administration date Sep2020 (Batch/Lot number: unknown) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HAIR GROWTH ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "noticed very sparse axillary hair growth on the side vaccine was administered."  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Gout flare up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 46 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GOUT (non-serious), outcome "unknown", described as "Gout flare up". Therapeutic measures were taken as a result of gout.  Additional information: The reporter stated that since he got his first dose of the Pfizer COIVD-19 vaccine he has been put on Prednisone for a Gout flare up and he is due to get his second dose of the Pfizer COVID-19 vaccine on 06Oct2021 but Thursday was his last day to be on the Prednisone. He was wondering if he should wait to be off the prednisone before getting his second dose. He spoke to 2-3 different pharmacies and he was given different answers.  The lot number for bnt162b2 was not provided and will be requested during follow up.