chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: Dizziness; Fatigue; Nausea; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 18 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Jul2021 (Lot number: EW0198, Expiration Date: Sep2021) at the age of 18 years 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: DIZZINESS (non-serious) with onset 15Jul2021, outcome "not recovered", described as "Dizziness"; FATIGUE (non-serious) with onset 15Jul2021, outcome "not recovered", described as "Fatigue"; NAUSEA (non-serious) with onset 15Jul2021, outcome "not recovered", described as "Nausea". Therapeutic measures were not taken as a result of dizziness, fatigue, nausea.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 31Jul2021 (Lot number: EW0168) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Hypertension; "pituitary brain tumor" (unspecified if ongoing), notes: verbatim: pituitary brain tumor; "heart palpitation" (unspecified if ongoing), notes: verbatim: heart palpitation. Concomitant medication(s) included: ATENOLOL. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "Headache"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "Nausea". Therapeutic measures were taken as a result of headache.  Additional information: Patient stated that she took that Pfizer shot about a week ago on Saturday. She had been having a headache ever since. She saw her doctor on 02Aug2021, endocrinologist, because she does have a pituitary brain tumor (history), but it had been in remission. She said that the side effects or headache would only be for two to three days. So, she was still having this headache. Patient stated, she visited lab on 02Aug.Treatment in response to adverse event: Patient stated she was taking over the counter Advil right then. All she took was Advil. Patient further stated that, she had little nausea too, so she did not know if that was the same thing or what. She just wanted to know because her doctor was telling her to drink a lot of water and until that she was doing that. Consumer stated, EW0168 wait a minute it looks like a B it could be B, her handwriting is terrible. Yes, it could be B as bravo (Consumer was unsure, hence not captured in tab). Prior vaccination (within 4 weeks), consumer stated, no, this was her first one and she was apprehensive about doing that.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Extrasystoles, Heart rate abnormal, Palpitations
Clinical narrative: bad heart palpitations; got worse again and have remained that way since; my heart is beating VERY hard; I'm skipping a beat about every 15 seconds or as bad as every 5 seconds; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28May2021 18:30 (Lot number: EW0185) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Light Emphysema (and hyper inflated lung)" (unspecified if ongoing); "hyper inflated lung" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, Lot number: EL9264, vaccine location=Right arm), when the patient was 64 years old, for Covid-19 immunnization, reaction(s): "bad heart palpitations". The following information was reported: PALPITATIONS (non-serious) with onset 2021, outcome "not recovered", described as "bad heart palpitations"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "not recovered", described as "got worse again and have remained that way since"; HEART RATE ABNORMAL (non-serious) with onset 2021, outcome "not recovered", described as "my heart is beating VERY hard"; EXTRASYSTOLES (non-serious) with onset 2021, outcome "not recovered", described as "I'm skipping a beat about every 15 seconds or as bad as every 5 seconds". The events "bad heart palpitations", "got worse again and have remained that way since", "my heart is beating very hard" and "i'm skipping a beat about every 15 seconds or as bad as every 5 seconds" were evaluated at the physician office visit. Therapeutic measures were taken as a result of palpitations, condition aggravated, heart rate abnormal, extrasystoles.  Additional information: It was reported that, one week after first shot, started having bad heart palpitations. Patient was skipping a beat about every 15 seconds or as bad as every 5 seconds. Since they seemed to improve slightly after 2 weeks or 3 weeks after first shot, patient went forward with second shot. They were not as bad for about a month and a half and then got worse again and have remained that way since. It was now more than three months after. Patient was skipping a beat about every 15 seconds or as bad as every 5 seconds. And patient heart was beating very hard. Not necessarily fast, but very hard at times. Just went to cardiologist. They believes they were probably from the vaccine. They had patient on Diltiazem 120 MG, calcium channel blockers and had taken for 4 days, but no change. No other vaccine in four weeks and no other medications in two weeks prior to covid vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm (not unbearable); This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2), administration date Mar2021 (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) with onset 2021, outcome "recovered" (2021), described as "sore arm (not unbearable)". 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-202101018905 same patient/vaccine, different AE and dose
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Got flu like symptoms 12 hours after vaccine; Really sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Other 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 (1st dose of covid vaccine), administration date: Mar2021, for COVID-19 immunization, reaction(s): "sore arm (not unbearable)". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Got flu like symptoms 12 hours after vaccine"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Really sore arm".  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-202101018904 same patient/vaccine, different AE and dose
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Skin burning sensation
Clinical narrative: burning feeling in his skin and has gotten worse since then; 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 right, administration date 15Jun2021 11:05 (Lot number: EW0162) at the age of 54 years 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: SKIN BURNING SENSATION (non-serious) with onset 15Jun2021, outcome "not recovered", described as "burning feeling in his skin and has gotten worse since then". The event "burning feeling in his skin and has gotten worse since then" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:The patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine on Jun2021 and since then he has a burning feeling in his skin and has gotten worse since then. The burning feeling has been shifting from place to place from hands to forehead. It's been going on since 15June. The patient did not receive the second dose. Hours later patient's skin was burning on tops of his hands. There was nothing visual on the skin, couldn't see anything, but the tops of hands and feet were burning. Felt as if he'd been sunburned. Has progressed and kind of shifted around the body. Feels like skin was burning in different places: forehead, lips, cheeks. Had been awful like torture. Had not gotten help from the doctors because nobody had seen this before. Patient was afraid. Patient expressed to caller one day that he felt like she was holding a hot iron to his forehead. It gets that bad. Patient had just stated it has progressed to his legs. This weekend feels like when limbs have fallen asleep and are coming out of that. Began approximately two hours after the first dose. Initially began on the backs of both hands. Came close several times to going to the ER. The patient went to Physician Office.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Sore neck after receiving a Covid vaccine; This is a spontaneous report received from non-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: NECK PAIN (non-serious), outcome "unknown", described as "Sore neck after receiving a Covid vaccine".  Additional information: patient was under age 18.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Oral disorder, Oral pain, Pain in jaw, Peripheral swelling, Trismus
Clinical narrative: a lock jaw and can not open her mouth on that side; a lock jaw and can not open her mouth on that side; mouth or jaw pain; mouth or jaw pain; swelling of the arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Aug2021 15:00 (Lot number: FA7485) at the age of 54 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Anatomical Location: Injection Left arm, Lot Number: FA6780), administration date: 10Jul2021, when the patient was 54 years old, for Covid-19 immunization. The following information was reported: TRISMUS (non-serious), ORAL DISORDER (non-serious) all with onset 06Aug2021 19:00, outcome "not recovered" and all described as "a lock jaw and can not open her mouth on that side"; ORAL PAIN (non-serious), PAIN IN JAW (non-serious) all with onset 06Aug2021 19:00, outcome "not recovered" and all described as "mouth or jaw pain"; PERIPHERAL SWELLING (non-serious) with onset Aug2021, outcome "unknown", described as "swelling of the arm".  Additional information: The vaccine was not administered at  facility. There were no emergency room and physician office visit. There were no prior vaccination within four weeks of first dose of BNT162B2. No adverse event prior vaccination reported.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dyspepsia
Clinical narrative: stomach ache; Heartburn/ stomach burns like she drank hot sauce; 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. The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Aug2021 11:00 (Lot number: FA7485) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 06Aug2021, outcome "not recovered", described as "stomach ache"; DYSPEPSIA (non-serious) with onset 06Aug2021, outcome "not recovered", described as "Heartburn/ stomach burns like she drank hot sauce". Therapeutic measures were taken as a result of abdominal pain upper, dyspepsia.  Additional information: Patient stated that as treatment for events she was drinking a lot of water. She was scheduled for the second dose on 27Aug2021. The events did not require visit to Emergency Room or Physician Office. Patient did not had any prior Vaccinations (within 4 weeks), any event following prior vaccinations and family medical history relevant to the adverse event. Also no additional vaccines were administered on the same date as the suspect and no lab test were performed.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Insomnia, Palpitations
Clinical narrative: complaints of insomnia; anxiety; heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administration date 20Apr2021 (Lot number: EW0161) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (first dose, LOT: EP7534), administration date: 30Mar2021, when the patient was 45 years old, for Covid-19 immunization. The following information was reported: INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "complaints of insomnia"; ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "anxiety"; PALPITATIONS (non-serious) with onset 2021, outcome "unknown", described as "heart palpitations".  Additional information:Patient after receiving the Pfizer Covid-19 vaccine started having complaints of insomnia and anxiety two weeks after receiving the second dose and stated that these complaints were causing him distress and he was not working. The reporter stated that when he first recognized it, it was about 12 or 13 days, somewhere between a week or two after second dose that he had insomnia. Further he said that he had never experienced this until after his second dose, around two weeks probably. He said that the insomnia had been the same ever since, some days he slept a couple hours, and some days he did not sleep at all or some nights he did not sleep at all. He said that he also had like heart palpitations, like anxiety.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 05Aug2021 (Lot number: FC3180) 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: HEADACHE (non-serious) with onset Aug2021, outcome "unknown", described as "Headache".  Additional information: While reporting side effects from the Covid vaccine, caller had mentioned that her husband received it at the same location but the day before. She had stated that who knows what goes into the syringes.  No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rhinorrhoea
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (LRN4386547). A 15-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 15, on Jul 20, 2021, single dose, for COVID-19 immunisation. The patient's medical history not reported. Concomitant medication included Evrysdi. The patient experienced fatigue/tired, onset Jul 2021, with outcome of unknown; and rhinorrhea/sniffles, onset Jul 26, 2021, with outcome of not recovered. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Dizziness, Eating disorder, Loss of personal independence in daily activities, Weight decreased
Clinical narrative: Weight loss; Has been in bed since getting the vaccine; Hasn't been able to eat; Feeling woozy; Unable to go to work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Lot number: EW0186) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Losing her taste and smell" (unspecified if ongoing), notes: Prior to getting the vaccine she was losing her taste and smell; "Losing her taste and smell" (unspecified if ongoing), notes: Prior to getting the vaccine she was losing her taste and smell. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot: EW0185, Route, Anatomical Location: Right arm), administration date: 16Jul2021, when the patient was 64 years old, for COVID-19 Immunization, reaction(s): "Her arm hurt". The following information was reported: BEDRIDDEN (non-serious) with onset 07Aug2021, outcome "not recovered", described as "Has been in bed since getting the vaccine"; WEIGHT DECREASED (non-serious) with onset 09Aug2021, outcome "unknown", described as "Weight loss"; DIZZINESS (non-serious) with onset 01Aug2021, outcome "not recovered", described as "Feeling woozy"; EATING DISORDER (non-serious) with onset 06Aug2021, outcome "not recovered", described as "Hasn't been able to eat"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "Unable to go to work".  Additional information: No Investigation Assessment was done. Patient took the Pfizer Covid shot on Friday after work. She has been in bed since then. Her weight was 106lbs. She is down to 104lbs. She hasn't been eating anything. Patient weighs daily. On Friday she was 106lbs. She got the shot after work and started feeling woozy. Prior to getting the vaccine she was losing her taste and smell. She missed a lot of work because of that and she was in pain. She went and was tested. The result was negative. She takes medication for low potassium. She also takes a water pill. She does not know the names. No history of all previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines administered on same date of the Pfizer Suspect. AE did not required Emergency Room and Physician Office visit. No Relevant Tests were done. Patient can't go to work. She feels like crap. This did something to her.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Pain in extremity
Clinical narrative: She later said it made her arm hurt.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Jul2021 (Lot number: EW0185) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "low potassium" (unspecified if ongoing), notes: She takes medication for low potassium. She also takes a water pill. She does not know the names. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "She later said it made her arm hurt.". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: My first vaccine shot 1/21/21. My arm was very sore for 3 days.; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2021 15:15 (Lot number: EL9263) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "sjogrens syndrome" (unspecified if ongoing); "hypo thyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: 2021. Past drug history included: Sulfa, reaction(s): "allergy: sulfa", notes: sulfa,; Augmentin, reaction(s): "allergic: augmentin/penicillin allergy", notes: Reported as penciling/Augmentin allergy. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21Jan2021, outcome "unknown", described as "My first vaccine shot 1/21/21. My arm was very sore for 3 days.". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient states her blood pressure 110/70 whole life. Her first vaccine shot received on 21jan2021 and her arm was very sore for 3 days. On 18Feb2021, she administered her second Covid-19 shot.The day after that shot she had fever, chills and soreness. Suddenly on July 25  she began vomiting which lasted into that night. For the next 5 days she remained very dizzy. By Sun. July 31, she checked herself into a hospital and her blood pressure was 207/94. She was given medication for BP, but it is still very erratic.  No follow-up attempts are possible. No further information is expected.  Follow-up#01 (19Aug2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101023581 same patient/reporter, different vaccine dose/AE
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Numbness and tingling in fingers on the right hand; Numbness and tingling in fingers on the right hand; Soreness on wrist and in right hand; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 29Jul2021 13:00 (Lot number: EW0179) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hbp" (unspecified if ongoing), notes: Other medical history: Hbp. Concomitant medication(s) included: DILTIAZEM. The following information was reported: HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 30Jul2021 06:30, outcome "not recovered" and all described as "Numbness and tingling in fingers on the right hand"; PAIN IN EXTREMITY (non-serious) with onset 30Jul2021 06:30, outcome "not recovered", described as "Soreness on wrist and in right hand". The events "numbness and tingling in fingers on the right hand", "numbness and tingling in fingers on the right hand" and "soreness on wrist and in right hand" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of hypoaesthesia, paraesthesia, pain in extremity.  Additional information: 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 had not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Hypoaesthesia oral, Myalgia, Paraesthesia oral
Clinical narrative: he got numbness and tingling in the nose and mouth area; Caller states everything felt like it was blowing up but it actually wasn't; he got numbness and tingling in the nose and mouth area; muscle soreness and weakness; muscle soreness and weakness; 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 60 year-old male patient received bnt162b2 (BNT162B2), administration date 14Jun2021 (Lot number: EW0177) as dose 1,single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: he was on blood pressure pills,, he was on an antibiotic.; "Cholesterol" (unspecified if ongoing), notes: he was on cholesterol pills. The patient took concomitant medications. The following information was reported: HYPOAESTHESIA ORAL (non-serious), PARAESTHESIA ORAL (non-serious) all with onset 14Jun2021, outcome "recovered" (15Jun2021) and all described as "he got numbness and tingling in the nose and mouth area"; FEELING ABNORMAL (non-serious) with onset 14Jun2021, outcome "recovered" (15Jun2021), described as "Caller states everything felt like it was blowing up but it actually wasn't"; MYALGIA (non-serious), ASTHENIA (non-serious) all with onset 14Jun2021, outcome "recovered" (Jun2021) and all described as "muscle soreness and weakness".  Additional information: COVID shot, clarified to vaccine, and he wanted to find out what it was that he is experienced so that he can proceed with the second one. 5 minutes after he had the COVID vaccine he had numbness and tingling in his nose and in the mouth area, it was like when you have Novocain, and it felt like everything was blowing up but when he looked in the mirror it wasn't blowing up, it was just the sensation of what was going on. That was basically it for his immediate reaction. Then after that he had the normal side effects later in the day such as muscle soreness and weakness. Those he was expecting to have but it was the reaction that he had five minutes afterwards that he had that he wasn't expecting. He wants to find out what that was, was it an allergic reaction or something else?   No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness/right arm feels numb a little bit; Pins and needle sensation/Caller voiced that she is experiencing paresthesia/right arm feels like pins and needles/right arm is tingling like numbness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Aug2021 14:30 (Lot number: FA6780, Expiration Date: 30Sep2021) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "idiopathic allergy" (unspecified if ongoing), notes: A few years ago she was diagnosed with an idiopathic allergy; "anaphylaxis to something" (unspecified if ongoing), notes: Years ago she had anaphylaxis to something but she does not know what. There were no concomitant medications. The following information was reported: HYPOAESTHESIA (non-serious) with onset 10Aug2021, outcome "not recovered", described as "Numbness/right arm feels numb a little bit"; PARAESTHESIA (non-serious) with onset 10Aug2021, outcome "not recovered", described as "Pins and needle sensation/Caller voiced that she is experiencing paresthesia/right arm feels like pins and needles/right arm is tingling like numbness".  Additional information: There was no history of any previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines were administered on same date of the Pfizer suspect. The facility where the most recent COVID-19 vaccine was administered was Grocery Store. The vaccine was not administered at Military Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient got her first vaccine that day around 14:30 pm and after receiving COVID-19 vaccine her right arm felt like pins and needles and numb a little bit. She was asking if that was normal. Tingling like numbness. This was the same arm she was vaccinated in. In regards to her arm, she stated she thinks she was fine. The patient wanted to know if there had been any reports of paresthesia after taking the Pfizer COVID-19 vaccine. The adverse events did not require a visit to Emergency room or Physician office. No relevant tests were done.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia
Clinical narrative: left numb on my left side; severe headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 22Jul2021 19:00 (Lot number: EW0177) at the age of 39 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 (1st Dose., Anatomical Site of injection: Right arm, Route of administration: Intramuscular, Batch/Lot Number: EW0178), administration date: 01Jul2021, when the patient was 39 years old, for COVID-19 immunization, reaction(s): "Pain", "Numb", "Severe Headache". The following information was reported: HYPOAESTHESIA (non-serious) with onset 22Jul2021 21:00, outcome "unknown", described as "left numb on my left side"; HEADACHE (non-serious) with onset 22Jul2021 21:00, outcome "unknown", described as "severe headache".  Additional information: VACCINATION FACILITY TYPE: Pharmacy or Drug Store. PATIENTS MEDICAL HISTORY: None.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: a lump in her left breast; She woke up this morning with a pain, and noticed the lump in her breast.; felt discomfort all over and in my left breast; Did not feel well; felt discomfort all over and in my left breast; felt very hot; 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 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Aug2021 (Lot number: PF12ER) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO taken for depression. The following information was reported: BREAST MASS (non-serious) with onset 10Aug2021, outcome "not recovered", described as "a lump in her left breast"; BREAST DISCOMFORT (non-serious), DISCOMFORT (non-serious) all with onset 09Aug2021, outcome "not recovered" and all described as "felt discomfort all over and in my left breast"; FEELING HOT (non-serious) with onset 09Aug2021, outcome "not recovered", described as "felt very hot"; BREAST PAIN (non-serious) with onset 10Aug2021, outcome "unknown", described as "She woke up this morning with a pain, and noticed the lump in her breast."; MALAISE (non-serious) with onset 09Aug2021, outcome "not recovered", described as "Did not feel well".  Additional information: Caller received her 1st Pfizer covid vaccine dose on 07Aug2021, then last night felt discomfort all over and in my left breast, I felt very hot. When she woke up this morning she had a lump in her left breast. Concomitant Products Lexapro was started 4 weeks ago. She got the first Pfizer BioNtech COVID 19 vaccine dosage on Saturday 07Aug2021 around 4-5 pm. Her side effect started last night, and she woke up with a large lump in her breast today 10Aug2021. She is wondering if this is a side effect. She did not have a prescribing doctor. She started with discomfort all over and in her breast last night around 10-10:30 PM on 09Aug2021. She was also hot and did not feel well. She woke up this morning with a pain and noticed the lump in her breast. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. AE(s) does not require any visit to emergency room/physician office. No prior vaccinations (within 4 weeks). No patient's medical history (including any illness at time of vaccination) or provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. No relevant tests, list other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI).  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Post herpetic neuralgia
Clinical narrative: post herpetic neuralgia; Dose 1 on 24Jan2021; Dose 2 on 22Aug2021 (Beyond 19-42 days); This is a spontaneous report received from contactable reporter(s) (Pharmacist and Physician).  A 78 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 22Aug2021 (Lot number: 014M20A) at the age of 78 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seropositive rheumatoid arthritis", start date: 08Aug2014 (ongoing). Concomitant medication(s) included: XELJANZ XR taken for rheumatoid arthritis (ongoing); METHOTREXATE taken for rheumatoid arthritis (ongoing). Vaccination history included: Bnt162b2 (First dose. Anatomical site of injection: unknown. Route of administration: intramuscular. Batch/Lot number: 032L20A., Patient received first covid vaccine 24jan2021. Reported she had been diagnosed with shingles by another provider 26Jan2021.), administration date: 14Jan2021, when the patient was 78 years old, for Covid-19 Immunisation, reaction(s): "Shingles"; Shingrix vaccine (Note patient received shingrix vaccine Nov2018 to Mar2019.), administration date: Nov2018, for Shingles.  The following information was reported: POST HERPETIC NEURALGIA (non-serious), outcome "unknown", described as "post herpetic neuralgia"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Dose 1 on 24Jan2021; Dose 2 on 22Aug2021 (Beyond 19-42 days)".  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Influenza, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 49-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0172), intramuscularly, in left arm, on Apr 22, 2021, at 12:00, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed influenza (flu symptoms), onset Apr 23, 2021, with outcome of recovered (Apr 24, 2021). Relevant laboratory tests and procedures available in the appropriate section. No therapeutic measures taken as a result of influenza. Additional information: The event did not require the initiation of new medication, other treatment or procedure. No follow-up attempts possible. No further information expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hot flush, Pain
Clinical narrative: moving around is making her dizzy; Headache; Hot and cold flashes; Body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Aug2021 08:30 (Lot number: EW0191) at the age of 23 years 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: HEADACHE (non-serious) with onset 10Aug2021 10:30, outcome "not recovered", described as "Headache"; HOT FLUSH (non-serious) with onset 10Aug2021 10:30, outcome "not recovered", described as "Hot and cold flashes"; PAIN (non-serious) with onset 10Aug2021 10:30, outcome "not recovered", described as "Body aches"; DIZZINESS (non-serious), outcome "unknown", described as "moving around is making her dizzy".  Additional information: She took the Covid-19 Vaccine at about 0830 this morning. She took the vaccine and one of the nurses told her to wait to see if she had side effects for 15 minutes after receiving the dose and she was fine. Around 10:30 she started to get a headache, hot and cold flashes, and her body aches real bad. The headache was not going away. She was at work and has notified her supervisor. she visited different doctors when she goes to the doctor s office. Her symptoms started about 30 minutes after she took the vaccine. She works in housekeeping and moving around is making her dizzy so she has to sit down. she stated that she has to go because she has a discharge room that she has to take care of as she is at work.   Follow-up attempts are completed. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Still have small red spots at both injection sights; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 13:30 (Lot number: EN6204) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "not recovered", described as "Still have small red spots at both injection sights".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm started hurting and now my hand; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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 "My arm started hurting and now my hand".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced pain in extremity (sore arm), onset 2021, with outcome of recovered (2021). No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-202101031523 same reporter/drug/event, different patient. US-PFIZER INC-202101031524 same reporter/drug/event, different patient. US-PFIZER INC-202101029522 same reporter/drug/event, different patient.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a non-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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: Caller (reporter) wanted to get her 10-year-old son vaccinated with Covid. Caller wanted to know when it being approved for under 12 years old, was there a Covid trial she could get her son into. She added her parents, her husband and herself all got the Pfizer Covid vaccine and none of them had any problems other than a sore arm for just a couple of hours.      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-202101031454 same reporter/drug/event, different patient.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Tenderness
Clinical narrative: Any time I move my arm, which is very tender now as opposed to when I initially received the vaccine, my hand will go numb and my whole arm tingles.; Any time I move my arm, which is very tender now as opposed to when I initially received the vaccine, my hand will go numb and my whole arm tingles.; Any time I move my arm, which is very tender now as opposed to when I initially received the vaccine, my hand will go numb and my whole arm tingles.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Aug2021 13:15 (Lot number: EW0176) at the age of 22 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Raynaud's phenomenon" (unspecified if ongoing); "GAD" (unspecified if ongoing); "known allergies: NSAIDs" (unspecified if ongoing), notes: known allergies: NSAIDs; "Covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: SERTRALINE; JOLESSA. The following information was reported: TENDERNESS (non-serious), HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 11Aug2021 05:15, outcome "unknown" and all described as "Any time I move my arm, which is very tender now as opposed to when I initially received the vaccine, my hand will go numb and my whole arm tingles.". Therapeutic measures were not taken as a result of tenderness, hypoaesthesia, paraesthesia.  Additional information: Facility type vaccine was hospital. Patient had not received other vaccine in four weeks. Patient had not tested covid post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Hangover, Malaise
Clinical narrative: I have not been right, feel like hangover and it has not gone away; I feel bad and completely horrible; I have not been right, feel like hangover and it has not gone away; I feel bad and completely horrible; I have not been right, feel like hangover and it has not gone away; I feel bad and completely horrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Aug2021 (Lot number: FC3180) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pneumonia" (not ongoing); "Covid", start date: 2020 (not ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious), FEELING ABNORMAL (non-serious), HANGOVER (non-serious) all with onset 04Aug2021, outcome "not recovered" and all described as "I have not been right, feel like hangover and it has not gone away; I feel bad and completely horrible".  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Pain, Vomiting
Clinical narrative: vomiting; body aches; and it got worse; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from.  A 29 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Aug2021 17:00 (Lot number: FA7485) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing), notes: Verbatim: Asthma. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number / Expiry Date: FA748, Route, Anatomical Location: into the muscle; Left arm), administration date: 08Jul2021, for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset Aug2021, outcome "not recovered", described as "dizziness"; VOMITING (non-serious) with onset 08Aug2021, outcome "not recovered", described as "vomiting"; PAIN (non-serious) with onset 08Aug2021, outcome "not recovered", described as "body aches"; CONDITION AGGRAVATED (non-serious) with onset 08Aug2021, outcome "not recovered", described as "and it got worse".  Additional information: Vaccination facility was Pharmacy/Drug Store. No emergency room visit or physicians office visit was required for the adverse events.   Follow-up attempts are completed. No further information is expected. No new information was given.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2) (Lot number: FA7484) 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: HEADACHE (non-serious), outcome "not recovered", described as "headache". Therapeutic measures were taken as a result of headache. Additional information: Reporter was concerned because her son did not generally get headaches and she had given him Ibuprofen repeatedly to treat.  No follow-up attempts are possible. No further information is expected.