chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm for three days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 70 year-old 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 (She got the Pfizer covid vaccine series but the first one,), for COVID-19 IMMUNIZATION. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm for three days".  Additional information: She got the Pfizer covid vaccine series but the first one, she turned her head away because she doesn't like to watch and she didn't feel a thing and no side effects and she is concerned the person may not have given her the first dose. She watched when she got the second dose and she had a sore arm for three days. Her pulmonary doctor said he was in bed with fever and all kinds of stuff for 12 hours after getting the vaccine.  She is concerned she may not have gotten the first one. Should she get a third one. No unaddressed medical questions referred or forwarded to Medical Information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Myalgia, Nausea
Clinical narrative: got her first vaccine on 26Feb. She got the second dose yesterday (15Mar).; Chills; Bad headache; Very bad muscle pain; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 65-year-old female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date 26Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing), notes: Verbatim: She mentioned that she has fibromyalgia. The patient's concomitant medications were not reported. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMIN-ISTRATION (non-serious), outcome "unknown", described as "got her first vaccine on 26Feb. She got the second dose yesterday (15Mar)."; CHILLS (non-serious), outcome "unknown", described as "Chills"; HEADACHE (non-serious), outcome "unknown", described as "Bad headache"; MYALGIA (non-serious), outcome "unknown", described as "Very bad muscle pain"; NAUSEA (non-serious), outcome "unknown", described as "Nausea".  Additional Information: The patient stated that she wanted to know if she can take some Ibuprofen. The patient had her second dose of COVID vaccine of Pfizer yesterday afternoon. She had chills most of the night and woke up with a bad headache. The patient had some very bad muscle pain and nausea.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hunger
Clinical narrative: hungry; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HUNGER (non-serious), outcome "unknown", described as "hungry".  Additional Information: Investigation assessment not provided. The reporter confirmed her friend told her that she was hungry after her COVID shot also.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Blood test
Clinical narrative: He has had issues with being off balance before so he does not know if it is anything to do with the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administration date 16Mar2021 10:00 (Batch/Lot number: unknown) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "sore back" (unspecified if ongoing); "Stem cell transplant" (unspecified if ongoing), notes: 3 years ago. Concomitant medication(s) included: ALEVE taken for back pain; XANAX, start date: 2011.  The following information was reported: BALANCE DISORDER (non-serious), outcome "unknown", described as "He has had issues with being off balance before so he does not know if it is anything to do with the vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported that he and his family received the first Pfizer vaccine at 10 AM. He wanted to ask a question, the doctor had him on, he was treating him for a sore back and he had taken, no one said anything about it but he does his own research (as reported). He had taken a 12 hour Aleve on Sunday night at 9:20 and also took a 12 hour Aleve in the morning on Sunday as well but the amount of time between the last dose of Aleve and the vaccination was 36 hours. He talked to 2 pharmacists that said that should not be a problem and a cousin of his who was a ER doctor to check with them and he did not think it would be a problem but he wanted to make sure with Pfizer. He wanted to know was there enough time between those or could there be any problem with the time between the medication and the vaccine. The patient was being monitored because he had a stem cell transplant 3 years ago and someone was supposed to come out Friday and do blood work and then came out the following Friday and checked him for the condition he had. It was him asking them to come out and check on him and do blood work on him because he can't leave the house. He was there with his wife and son. His son had down syndrome and he had the shot and his wife had her shot and she had Alz, he said those were just the first letters of the word, he did not want to say the whole word out loud but it was regarding her memory. He already had taken medicine from Pfizer. He was taking 1.5 mg of Xanax XR (Pfizer brand) and he reported that he can't take generic because it caused him issues. He clarified that was the 1 mg. He did not have any bottles of generic Xanax XR to provide any generic name NDC lot expiration. He said that was a long time ago. He had not taken the generic for years he had been on the brand product since 2011.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: paresthesia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (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: PARAESTHESIA (non-serious), outcome "unknown", described as "paresthesia".  Additional Information: The suspect product is reported as Covid-19 Vaccine and unspecified if the Covid-19 vaccine is a Pfizer product. He received the first dose on 26Feb2021. He experienced paresthesia in his right leg that moved to both legs and feet, arms and hands. Patient reported that other people have had the same thing. No details were provided. He was asking if it is likely to get worse or will it go away.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort, Musculoskeletal discomfort, Nasal congestion, Pain, Seasonal allergy
Clinical narrative: Discomfort on the arm after vaccine; Had a very stuffy nose which could be allergies that I am having this time of the year/Stuffiness; Had a very stuffy nose which could be allergies that I am having this time of the year/Stuffiness; Pain; discomfort again on the same arm and yesterday night, was very bad, it went all the way up to the neck, the shoulder and the neck of the arm; discomfort again on the same arm and yesterday night, was very bad, it went all the way up to the neck, the shoulder and the neck of the arm; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm, administration date 02Mar2021 (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: LIMB DISCOMFORT (non-serious) with onset 02Mar2021, outcome "recovered" (03Mar2021), described as "Discomfort on the arm after vaccine"; NASAL CONGESTION (non-serious), SEASONAL ALLERGY (non-serious) all with onset Mar2021, outcome "unknown" and all described as "Had a very stuffy nose which could be allergies that I am having this time of the year/Stuffiness"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Pain"; LIMB DISCOMFORT (non-serious), MUSCULOSKELETAL DISCOMFORT (non-serious) all with onset Mar2021, outcome "unknown" and all described as "discomfort again on the same arm and yesterday night, was very bad, it went all the way up to the neck, the shoulder and the neck of the arm". Therapeutic measures were taken as a result of nasal congestion, seasonal allergy.  Additional information:Patient took the Pfizer Vaccine on 02Mar (first day) experienced a little discomfort on the arm after vaccine. But the next day it went away. On Saturday (as per report), patient thought it was the 12th day, started experiencing some discomfort again on the same arm and yesterday night, was very bad, it went all the way up to the neck, the shoulder and the neck of the arm that was vaccinated. Patient also had a very stuffy nose which could be allergies that having this time of the year, but very stuffy. This morning patient had to take anti-histamine(treatment), so that could breathe better. Patient is due to take second shot on Tuesday of next week on the 23rd. Patient was not sure to go for it or should wait until this stuffiness and pain is gone.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: received the first dose yesterday and all he had was a little soreness like with the Flu shot/clarified that his left arm is sore, and his left arm is where he got the injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 (Lot number: Unknown) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included HIV (unspecified if ongoing), he is immune deficient; Chronic COPD (unspecified if ongoing); Type II Diabetes (unspecified if ongoing); Fibromyalgia (unspecified if ongoing); Asthma (unspecified if ongoing). There were no concomitant medications. Vaccination history included Flu shot (clarified that his left arm is sore, and his left arm is where he got the injection), administration date: Sep2020, when the patient was 55 years old, reaction(s) little soreness. The following information was reported VACCINATION SITE PAIN (non-serious) with onset 15Mar2021, outcome unknown.   He received the first dose yesterday and all he had was a little soreness like with the Flu shot. The soreness started 3 hours after the vaccine. His first dose was on 15Mar2021. Second dose is on 04Apr2021. It was recommended and he has no problems taking vaccines. Flu shot: Reporter doesn't have NDC, lot, and expiry to provide for Flu shots that caused a little soreness. His most recent flu shot was Sep2020. Reporter clarified that his left arm is sore and his left arm is where he got the injection.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: when he had his first COVID vaccine that his arm was sore but it was not black and blue with a bruise like hers was; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "when he had his first COVID vaccine that his arm was sore but it was not black and blue with a bruise like hers was".  Additional information: Reporter stated that patient said that when he had his first COVID vaccine that his arm was sore but it was not black and blue with a bruise like hers was. Reporter declined to complete a safety report for the patient.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Full body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 15Mar2021 13:45 (Lot number: EL3247) at the age of 46 years as unknown, single for covid-19 immunisation. Relevant medical history included: "birth control" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAIN (non-serious) with onset 16Mar2021 16:00, outcome "recovered" (Mar2021), described as "Full body aches". Therapeutic measures were taken as a result of pain.Ae treatment with Advil.  Additional information:Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19.the patient hasn't been tested for COVID-19.No history of allergy.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Asthenia, Fatigue, Malaise
Clinical narrative: Tiredness; Weakness; Do not feel good; I am losing my voice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Lot number: EN6198) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing); "Degenerative disc disease" (unspecified if ongoing); "Scoliosis", start date: 2011 (unspecified if ongoing); "irritable bowel syndrome", start date: 2011 (unspecified if ongoing); "GERD", start date: 2011 (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN. Vaccination history included: Bnt162b2 (LOT# of First shot: E19269), administration date: 10Feb2021, when the patient was 66 years old, for COVID-19 IMMUNISATION. The following information was reported: APHONIA (non-serious) with onset Mar2021, outcome "unknown", described as "I am losing my voice"; FATIGUE (non-serious) with onset 04Mar2021, outcome "unknown", described as "Tiredness"; ASTHENIA (non-serious) with onset 04Mar2021, outcome "unknown", described as "Weakness"; MALAISE (non-serious) with onset Mar2021, outcome "unknown", described as "Do not feel good".  Additional Information: It was reported that NDC number, UPC number and Expiry date of COVID-vaccine was Unknown. Patient took COVID vaccine as a preventive measure of COVID.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pain in extremity
Clinical narrative: stated that she feels weak; has a bad pain in her left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 (Batch/Lot number: unknown) at the age of 67 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ACETAMINOPHEN taken for pain. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "not recovered", described as "has a bad pain in her left arm"; ASTHENIA (non-serious), outcome "unknown", described as "stated that she feels weak". Therapeutic measures were taken as a result of pain in extremity.  Additional information: Patient reported that she got her vaccine 03Mar stated that she knows that the pain in the arm for most people is supposed to be 2-3 days. Stated that she still has a bad pain in her arm. Stated she feels weak. Stated that she takes Acetaminophen for pain and it does not help. Stated that she is to receive the second one 25Mar. Patient clarified that it is her left arm. Patient reported that the pain started two weeks after the vaccine. Stated that she feels relief when she puts something hot on it or takes pain killers.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site pain
Clinical narrative: He gave it to me quite high and in the right deltoid and I felt an immediate like a Nerve reaction going up to my neck and then that went away and that went through my arm into my hand.; Right now my whole upper arm is really sore; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in deltoid right (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "He gave it to me quite high and in the right deltoid and I felt an immediate like a Nerve reaction going up to my neck and then that went away and that went through my arm into my hand."; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Right now my whole upper arm is really sore". Additional information: The patient was wondering, and got the second dose of vaccine. The patient was a Nurse and knew a little bit about this 'Covid' vaccine. The patient got vaccine quite high and in the right deltoid and felt an immediate like a nerve reaction going up to the neck and then that went away and that went through the arm into the hand. At the time of report, the whole upper arm was really sore. At the time of report, to look at the injection site, it was fine. That does not hurt. So, the patient did not knew to take some Tylenol or Ibuprofen or something and queried whether it was contraindicated right after. Further information could not be probed as the Nurse did not want to share further information. Limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: he was sick and could not get the second dose; missed his 2nd dose on March 6, 2021; 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 male patient received bnt162b2 (BNT162B2), administration date 13Feb2021 (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: ILLNESS (non-serious), outcome "unknown", described as "he was sick and could not get the second dose"; PRODUCT DOSE OMISSION ISSUE (non-serious), outcome "unknown", described as "missed his 2nd dose on March 6, 2021". Additional information: Patient got the 1st dose of the vaccine on 13Feb2021 and missed his 2nd dose on 06Mar2021. Patient wanted to reschedule his 2nd dose, he was sick and could not get the second vax and now was asking to schedule again. He stated he had contacted the health department and was told to contact. The patient was only getting the run around and was fed up with this and hung up.   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: Tinnitus
Clinical narrative: Increased ringing in ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm right, administration date 17Feb2021 (Lot number: EL9267) at the age of 77 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "High Cholesterol" (ongoing); "Verbatim: Allergies" (ongoing); "Verbatim: Sneezing" (ongoing); "Verbatim: Runny Nose" (ongoing), notes: Runny Nose due to time of year; "Rapid Heart Beat" (ongoing); "Tinnitus" (unspecified if ongoing), notes: The patient has had this problem before and has had tinnitus for many years. Concomitant medication(s) included: ATENOLOL taken for heart rate increased (ongoing).  The following information was reported: TINNITUS (non-serious) with onset 18Feb2021, outcome "not recovered", described as "Increased ringing in ear". Therapeutic measures were not taken as a result of tinnitus.  Additional information: The patient reported that the right ear seems to be ringing worse than the left; she believes the ringing to be in both ears. The patient also said that at times it has gotten better, hasn't worsened, but remains steady. The event did not require a visit to emergency room and physician office. The patient did not receive vaccinations within 4 weeks.   No follow-up attempts are possible. No further information is expected.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache
Clinical narrative: Terrible headache; I felt weak for about five hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 96 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Mar2021 (Batch/Lot number: unknown) at the age of 96 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Neuropathy peripheral" (unspecified if ongoing), notes: Verbatim: Neuropathy; "Seizure" (unspecified if ongoing), notes: Verbatim: Seizures; "blood clots" (unspecified if ongoing), notes: Consumer stated, "I have blood clots, I had one may be about nine years ago and there was small one in leg about seven years ago, I take 'Clonidine' (not clarified), I take 2 mg and 3 mg, sometimes I have to take 2 and at certain days I have to take 3 mg, it is a little pill. I take it orally everyday." (medication name not clarified, hence not captured in tab). Concomitant medication(s) included: GABAPENTIN taken for neuropathy peripheral; PHENYTOIN taken for seizure. The following information was reported: HEADACHE (non-serious) with onset 14Mar2021, outcome "recovered" (14Mar2021), described as "Terrible headache"; ASTHENIA (non-serious) with onset 14Mar2021, outcome "recovered" (14Mar2021), described as "I felt weak for about five hours". Therapeutic measures were taken as a result of headache, asthenia.  Additional information: Phenytoin; Dosage text: one in morning and one in night, capsule, orally. Consumer stated, "I have blood clots, I had one may be about nine years ago and there was small one in leg about seven years ago, I take 'Clonidine' (not clarified), I take 2 mg and 3 mg, sometimes I have to take 2 and at certain days I have to take 3 mg, it is a little pill. I take it orally every day." I have Neuropathy and it is in my feet and hands and it was about 5-6 years ago it started and it was very mild otherwise I am okay. I take Gabapentin and I think it is 400 mg (consumer was not sure of the dose)." Treatment: Consumer stated, "They told me to take Tylenol and that is all I took, the extra strong and it is over the counter. I took two and I laid down and then I woke up then it started again, so I took one, so throughput the day I took three, it is 500 mg each and it is capsule. I took two after I got the shot and one was four hours after."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: a couple hours after I got the vaccine, I have had some tingling in my left leg; It kind of looks like it is numb, but it is not, but it is like tingling; It kind of feels like needles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 16Mar2021 (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: PARAESTHESIA (non-serious) with onset 16Mar2021, outcome "unknown", described as "a couple hours after I got the vaccine, I have had some tingling in my left leg; It kind of looks like it is numb, but it is not, but it is like tingling; It kind of feels like needles".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Breast swelling, Nipple pain
Clinical narrative: breasts kind of swollen; back of nipples sore; breasts kind of swollen; back of nipples sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 24Feb2021 11:00 (Lot number: EL9267) at the age of 72 years as 1st dose, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BREAST SWELLING (non-serious), NIPPLE PAIN (non-serious) all with onset 26Feb2021, outcome "not recovered" and all described as "breasts kind of swollen; back of nipples sore". Additional information: RA number and Expiry Date of Pfizer COVID 19 vaccine were unknown. Reporter noticed a couple days after receiving the shot his breasts were kind of swollen, like back in his nipples, it was kind of sore and has stayed sore. He was asking had Pfizer seen this type of reaction before, He was assuming it was from the vaccine. He has read that some females had had some gland issues and under their arms with lymph nodes. He had also read something about mammograms being falsely read. Reporter declined to include a healthcare professional. Reporter explained he noticed this swelling and soreness in his breasts/nipples about 48 hours after receiving the shot, clarified as 26Feb2021. He clarified it was like a lumpy feeling back in his nipple area and its sore to touch. He stated this had stayed about the same. Vaccine Administered was not at Facility. No additional vaccines was administered on same date of the Pfizer suspect. No visit to emergency room or physician office was required. No prior vaccination in four weeks was there and no adverse events following prior vaccination occurred. No relevant lab tests were there.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: headache; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 (Lot number: EL3247) at the age of 37 years as dose 2 single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, Lot Number: EL3247 ), administration date: 23Feb2021, for covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 16Mar2021, outcome "recovered", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 16Mar2021, outcome "recovered", described as "sore arm". Therapeutic measures were not taken as a result of headache, pain in extremity. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site was tender but gone the next day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Injection site was tender but gone the next day".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Vaccination site pain
Clinical narrative: Upset stomach; soreness at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Mar2021 16:00 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Haemodialysis", start date: Jun2012 (unspecified if ongoing); "Open heart surgery" (unspecified if ongoing); "Heart valve replacement", start date: 2017 (unspecified if ongoing); "pacemaker", start date: 2017 (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 13Mar2021, outcome "recovered" (15Mar2021), described as "soreness at injection site"; ABDOMINAL DISCOMFORT (non-serious) with onset 15Mar2021, outcome "not recovered", described as "Upset stomach".  Additional information: Patient was having side effects from the Covid-19 vaccine. He had soreness at the injection site. He was unsure if it was what he ate or a reaction to the vaccine. Yesterday he had an upset stomach. He read where that was mentioned in the paperwork. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) were reported as none. Relevant Tests were reported as none. Patient was unable to clearly read the handwriting on the card as it was illegible. He think the Lot was EL92CR1.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; her arm is a little sore, but not excruciating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 (Lot number: EN6204, Expiration Date: 30Jun2021) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "allergic", notes: 50 years ago. Vaccination history included: Bnt162b2 (First vaccine dose received on 21Feb2021, LOT: EL9267 Expiration: 31May2021 Left Arm), administration date: 21Feb2021, when the patient was 71 years old, for Covid-19 immunisation, reaction(s): "no adverse event". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Mar2021, outcome "recovering", described as "her arm is a little sore, but not excruciating"; HEADACHE (non-serious) with onset 16Mar2021, outcome "recovering", described as "Headache". Therapeutic measures were not taken as a result of pain in extremity, headache.  Additional information: Caller stated that she is calling because she had her second dose of the shot and she has a headache, asks is she allowed to take Tylenol. Caller stated that she has no fever, her arm is a little sore, but not excruciating. Stated that she rarely gets headaches, this is the first one she has had in a while. Caller stated that her husband told her to take Tylenol. States the nurse didn't say anything to her. Stated her husband was told to move his arm and she wasn't told to move her arm even, stated she guesses it depends on who gives the shot what instructions are given. Caller stated that she has never had a hangover before in her life, it is a constant headache, no fever. She stated the more she slept the better it felt. Caller stated she is sure if she is allowed to take Tylenol, it would work but she didn't want to affect vaccination. She stated that she knows before the vaccine it is not allowed but she doesn't know about after. And also stated as she is talking her headache is going away.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling of injection site; soreness at injection site; tenderness in left arm; This is a spontaneous report received from 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 08Mar2021 12:45 (Lot number: EN6199) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL AND CHLORTHALIDONE taken for hypertension, start date: 2010 (ongoing). The following information was reported: TENDERNESS (non-serious) with onset 09Mar2021, outcome "recovered" (10Mar2021), described as "tenderness in left arm"; VACCINATION SITE SWELLING (non-serious) with onset 16Mar2021, outcome "not recovered", described as "Swelling of injection site"; VACCINATION SITE PAIN (non-serious) with onset 16Mar2021, outcome "recovering", described as "soreness at injection site".  Additional information: Caller received the first dose Covid-19 vaccine. The day after, she had tenderness in her left arm. It went away and she was fine. This morning the injection site was very swollen and sore again. The patient did not have history of all previous immunization with the Pfizer vaccine considered as suspect. The adverse events did not require emergency room visit. The patient did not receive any other vaccine within four weeks. The patient did not perform any relevant test.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Headache
Clinical narrative: With his second COVID vaccine he felt warm; headache; he just felt very tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male 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 (Dose: 1), for covid-19 immunisation, reaction(s): "his arm was sore". The following information was reported: FEELING HOT (non-serious), outcome "unknown", described as "With his second COVID vaccine he felt warm"; HEADACHE (non-serious), outcome "unknown", described as "headache"; FATIGUE (non-serious), outcome "unknown", described as "he just felt very tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021302405 same reporter /drug, , different patient and event
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Seasonal allergy
Clinical narrative: seasonal allergies; sore throat; 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 male patient received bnt162b2 (BNT162B2) (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: SEASONAL ALLERGY (non-serious), outcome "unknown", described as "seasonal allergies"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat".  Additional information: The patient was scheduled to take his 2nd dose of Covid-19 Vaccine the next day.  No follow-up attempts are possible. Information about lot or batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore on left arm on site of shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Feb2021 (Lot number: EL 9261) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, Time: 11:30 Am/ 12:30 Am, Anatomical site: left arm, Batch/Lot no: EL9261), administration date: 23Jan2021, when the patient was 73 years old, for COVID-19 IMMUNISATION, reaction(s): "arm soreness". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "sore on left arm on site of shot".  Additional information: Vaccine administration time at 10:am/ 10:30am. Sore on left arm on site of shot which was no more than 2 days. No Prior vaccination and no relevant tests.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Headache, Pain in extremity
Clinical narrative: sore arm; headache could not shake; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Mar2021 10:00 (Lot number: EN6199) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Time(24hr): 04:30 PM, Anatomical site of Location: Left upper arm, Batch/Lot number: E19267, Route Of administration: Intramuscular), administration date: 10Feb2021, when the patient was 58 years old, for Covid-19 immunisation, reaction(s): "had temp. of 103", "Sore arm", "very light headed likewise going to pass out". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache could not shake"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:  Vaccine Facility Type was Doctor's office/Urgent care for (1st shot) and Community facility for (2nd shot). Patient did not receive any other vaccines within 4 weeks PRIOR to the COVID-19 vaccine. Concomitant drugs were reported as none.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: little bit of pain with moving her hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 17:00 (Lot number: EN6202) at the age of 54 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Therapy dates: 11Feb2021 at 13:00PM , NDC number: Unknown, Lot Number: EL9269, Expiry date: Unknown, dose 1), administration date: 11Feb2021, when the patient was 54 years old, for covid-19 immunisation, reaction(s): "redness and pain at the injection", "redness and pain at the injection". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 11Mar2021, outcome "recovered" (14Mar2021), described as "little bit of pain with moving her hand".  Additional Information: Consumer reported, she received the first dose of the Pfizer COVID 19 vaccine on 11Feb2021 at 13:00PM in the left arm. After the first dose she had redness and pain at the injection site that gradually went away after three days. She also noticed a little bit of pain with moving her hand which also went away gradually after the second dose. States she received the second dose on 04Mar2021 at 17:00PM in the left arm. After the second dose she had no reaction; nothing at all. Mentioned she received the second dose at a different vaccination location from the first dose and it was done in some conditions that concerns her about whether she got the actual vaccine, and that the vaccine was at the limit of its expiration. She was also questioning whether the vaccine was stored properly. Mentions when she got to the vaccination location she discovered the vaccine was within 24 hours of the expiration of the product and it had been transferred from one area to another area because it was not used. She didn't know this ahead of time. She was unsure of the expiration date as it is not on her card. She was asking what if the vaccine is expired? Is there a way she can check to see if she has antibodies to COVID 19? Adds she had called before to ask about her health conditions and the interaction with the vaccine. She does not have a report reference number to provide from that call. They called her back and she had a very good experience. This will be a follow up.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, SARS-CoV-2 test
Clinical narrative: muscle ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Feb2021 15:30 (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Stomach" (unspecified if ongoing), notes: Stomach; "Blood pressure" (unspecified if ongoing), notes: Blood pressure; "Cholesterol" (unspecified if ongoing), notes: Cholesterol. Concomitant medication(s) included: NORTRIPTYLINE taken for abdominal discomfort; LISINOPRIL taken for blood pressure abnormal; ATORVASTATIN taken for blood cholesterol abnormal. Vaccination history included: Bnt162b2 (First Dose), administration date: 28Jan2021, for Covid-19 immunisation, reaction(s): "Back pain"; Bnt162b2 (First Dose), administration date: 29Jan2021, for Covid-19 immunisation, reaction(s): "Pain in arm". The following information was reported: MYALGIA (non-serious) with onset 19Feb2021, outcome "unknown", described as "muscle ache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had no prior vaccinations (within 4 weeks).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: She now has a head cold and wants to know if it's safe to get the 2nd dose or not; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (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: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "She now has a head cold and wants to know if it's safe to get the 2nd dose or not".  Additional information: Patient was supposed to get her 2nd dose tomorrow.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: stiff arm; a very sore throat; cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "stiff arm"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "a very sore throat"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Seasonal allergy
Clinical narrative: Seasonal allergies; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEASONAL ALLERGY (non-serious), outcome "unknown", described as "Seasonal allergies".  Additional information: It was reported that rhe patient received 1st dose on 15Mar2021. Started experiencing seasonal allergies. Called to know if it is safe to take allergy medicine. Unaddressed medical questions were referred or forwarded to Medical team.  No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.