chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypertension, Pyrexia, Vaccination site pain
Clinical narrative: developed stage-2 hypertension after the vaccination; Headaches that have not subsided and continued for 3 weeks post vaccination; pain the right arm for 3-4 days; Fatigue that lasted for 2 to 4 days; Fever that lasted for 2 to 4 days; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (developed stage-2 hypertension after the vaccination), HEADACHE (Headaches that have not subsided and continued for 3 weeks post vaccination), VACCINATION SITE PAIN (pain the right arm for 3-4 days), FATIGUE (Fatigue that lasted for 2 to 4 days) and PYREXIA (Fever that lasted for 2 to 4 days) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (Seasonal allergies).    On 04-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2022, the patient experienced HYPERTENSION (developed stage-2 hypertension after the vaccination), HEADACHE (Headaches that have not subsided and continued for 3 weeks post vaccination), VACCINATION SITE PAIN (pain the right arm for 3-4 days), FATIGUE (Fatigue that lasted for 2 to 4 days) and PYREXIA (Fever that lasted for 2 to 4 days). The patient was treated with HYDROCHLOROTHIAZIDE for Hypertension, at an unspecified dose and frequency. In February 2022, VACCINATION SITE PAIN (pain the right arm for 3-4 days), FATIGUE (Fatigue that lasted for 2 to 4 days) and PYREXIA (Fever that lasted for 2 to 4 days) had resolved. At the time of the report, HYPERTENSION (developed stage-2 hypertension after the vaccination) and HEADACHE (Headaches that have not subsided and continued for 3 weeks post vaccination) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were taken by patient. The patient had not undergone any previous positive COVID test or was not previously diagnosed with COVID-19. The patient had experienced multiple adverse reactions post vaccination.  On 23-Feb-2022, the patient went to check with the physician and was prescribed with Hydrochlorothiazide.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used-beyond use date of 15 Jan 2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used-beyond use date of 15 Jan 2022) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.   No Medical History information was reported.    On 20-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used-beyond use date of 15 Jan 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used-beyond use date of 15 Jan 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant  medication was not reported. Treatment medication was not reported.  Moderna vaccine was pulled from freezer on 16-Dec-2021. Beyond use date of 15-Jan-2022 was printed in red and taped to the top of boxes. On 26-Jan-2022, Staff noticed that vaccine was still in the fridge and expired and 5 doses had been given at that point. On 31-Jan-2022, Moderna confirmed that revaccination was not required.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 expired- Doses had been given at that potint; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 expired- Doses had been given at that potint) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.  On 20-Jan-2022 at 10:56 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 20-Jan-2022 at 10:56 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 expired- Doses had been given at that potint). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 expired- Doses had been given at that potint) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported. It was reported that, Moderna vaccine was pulled from freezer on 16-Dec-2021. BUD date of 15-Jan-2022 printed in red and taped to the boxes. On 26-Jan-2022 staff brought it to attention that it was still in the fridge and expired.~ No treatment information was reported.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired- 5 Doses had been given at that potint; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired- 5 Doses had been given at that potint) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2022 at 5:43 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired- 5 Doses had been given at that potint). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired- 5 Doses had been given at that potint) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  It was reported that Moderna vaccine was pulled from freezer on 16 Dec 2021 and beyond use date was 15 Jan 2022. On 26 Jan 2022, staff brought it to attention that it was still in fridge and expired and 5 doses had been given. Patient denied any adverse effects. On 31 Jan 2022 Moderna responded that revaccination was not required.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 expired Doses had been given at that potint; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 expired Doses had been given at that potint) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2022 at 9:45 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2022 at 9:45 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (5 expired Doses had been given at that potint). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 expired Doses had been given at that potint) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Moderna vaccine was pulled form the freezer on 16-Dec-2021. The Beyond use date was 15-Jan-2022 printed in red and taped to the top of the boxes. On 28-jan-2022, It was noted that the vaccine was still in the fridge and expired. On 31-Jan-2022, Moderna responded that revaccination not required. No treatment medications were reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of accidental underdose (immunocompromised patient supposed to get third dose but given half dose of 0.25mL instead) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 018F21A) for COVID-19 immunization. Concurrent medical conditions included being immunocompromised. On Jan 28, 2022, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 0.25 milliliter. On Jan 28, 2022, patient experienced accidental underdose (immunocompromised patient supposed to get third dose but given half dose of 0.25mL instead). At the time of the report, accidental underdose (immunocompromised patient supposed to get third dose but given half dose of 0.25mL instead) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: booster dose administered out of vial punctured more than 12 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster dose administered out of vial punctured more than 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2022 at 1:10 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster dose administered out of vial punctured more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (booster dose administered out of vial punctured more than 12 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Reporter Stated that, the vials were stored at room temperature post puncture and the vials did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree Celsius to 25 degree Celsius are about 20 hours and 40 minutes.  Treatment details was not reported by the reporter.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Migraine
Clinical narrative: Feeling weak after booster; Migraine after booster; Felt like fainting after booster; Terrible Headache after booster; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feeling weak after booster), MIGRAINE (Migraine after booster), DIZZINESS (Felt like fainting after booster) and HEADACHE (Terrible Headache after booster) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced ASTHENIA (Feeling weak after booster), MIGRAINE (Migraine after booster), DIZZINESS (Felt like fainting after booster) and HEADACHE (Terrible Headache after booster). The patient was treated with PROPRANOLOL at an unspecified dose and frequency; DICLOFENAC POTASSIUM (CAMBIA) at an unspecified dose and frequency; BOTULINUM TOXIN TYPE A (BOTOX) at an unspecified dose and frequency; DICLOFENAC at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 18-Nov-2021, ASTHENIA (Feeling weak after booster) and DIZZINESS (Felt like fainting after booster) had resolved. At the time of the report, MIGRAINE (Migraine after booster) and HEADACHE (Terrible Headache after booster) had not resolved.            Concomitant medication details were not reported by the reporter.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Flu like symptoms; the dose was left at room temperature and later administered to a patient the following day, about 20 hours later; It was temperature excursion that makes the vaccine expired; This is a spontaneous report from a contactable pharmacist. A 17-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: FA7485; Expiration Date: 30Oct2021), via an unspecified route of administration on 27Jul2021 (at the age of 17-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient was unknown reported. The concomitant medication of the patient included few medications, but it was just antibiotics and some cream like. Pharmacist (reporter) reported on behalf of a 17-year-old male patient, who was administered a dose of the vaccine after excursion. Stated she had drawn the Pfizer covid vaccine the previous day at 2:30, however the dose was left at room temperature and later administered to a patient the following day, about 20 hours later. She wanted to know how to proceed after inadvertently administering a dose of expired vaccine to a patient. It looks like it was left out yesterday and administered around noon today on 23Jul2021. The pharmacist stated did not know what that go about, do we give another new dose to that patient if it is possible or what do we do from here because it was 3 days and they don't know what to do and concerned about only Pfizer guidance. So that something would call or what to do. Pharmacist added the vaccine are only good for 6 hours at room temperature, if the vaccine had undergone temperature excursion, pharmacist stated, assuming because it was at room temperature, they drew the dose around like 02:30 so it was good for like 6 hours. So they tried to figure out after that what happens after 6 hours beyond or something. Technically yes it was temperature excursion that makes the vaccine expired, correct. Patient experienced Flu like symptoms on 27Jul2021 at 15:00. The patient did not receive any treatment for the events. Reporter considering events as non serious. Outcome of the event Flu like symptoms was resolved on unspecified date in 2021.  Follow-up (26Jul2021): This is a follow-up spontaneous report from a contactable Pharmacist. This Pharmacist reported for a patient that includes: expiration date of the vaccine was added, new event "Product temperature excursion issue " was added and the event "Expired vaccine" used was deleted and coded as poor quality vaccine administered.  Follow-up (13Aug2021): This is a follow up-spontaneous report from a contactable Other HCP. This Other HCP reported in response to HCP letter sent via follow-up letter which included that: Product start date updated, New Event Flu like symptoms added and other clinical information was updated.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain in extremity, Paraesthesia
Clinical narrative: My legs was hurting; Tingling all over my body; weak; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administration date 27Jul2021 (Lot number: ER8732, Expiration Date: 31Jul2021) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; AMLODIPINE; PROTONIX [OMEPRAZOLE] taken for gastrooesophageal reflux disease.  The following information was reported: ASTHENIA (non-serious) with onset 27Jul2021, outcome "unknown", described as "weak"; FATIGUE (non-serious) with onset 27Jul2021, outcome "unknown", described as "Tired"; PAIN IN EXTREMITY (non-serious) with onset 28Jul2021, outcome "unknown", described as "My legs was hurting"; PARAESTHESIA (non-serious) with onset 28Jul2021, outcome "unknown", described as "Tingling all over my body". Therapeutic measures were not taken as a result of asthenia, fatigue, pain in extremity, paraesthesia.  Additional information: Patient took the vaccine Tuesday this week,  this was her first vaccine and after she took it she was real weak and tired for rest of the all day,  she knew it was normal and the next day her legs, both herl egs were hurting real bad and it was one of the side effects also, okay tonight her legs was hurting and they started tingling all over her body." consumer stated, "I took gabapentin my daily medicine. I just took it 35-40  minutes ago, it is my daily medication." (Concomitant medication), While reconfirming treatment taken in response to event: consumer stated, "No, I have not." Consumer stated about other medications that, "Not tonight just one pill I took tonight, I am taking other medication but if the only thing I took tonight. I guess, I go to neurologist doctor, for neurology reason." (Further clarification unknown). Patient did not receive Prior vaccination (Within 4 weeks) .  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Muscle spasms, Tenderness
Clinical narrative: headache that became worse the following day; tenderness of her left upper arm that felt real sensitive; muscle spasm/pain in her left thigh; The headache was like a migraine that she had for 2-2.5 days, she still has it but its going away; 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 53 year-old female patient received bnt162b2 (BNT162B2, Solution for injection), administered in arm left, administration date 28Jul2021 15:30 (Lot number: FA6780) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart murmur" (unspecified if ongoing), notes: Diagnosed when the caller was a baby.; "Blood pressure high" (unspecified if ongoing); "Acid reflux (esophageal)" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder; AMLODIPINE taken for hypertension; DEXILANT taken for gastrooesophageal reflux disease. The following information was reported: HEADACHE (non-serious) with onset 28Jul2021, outcome "recovering", described as "headache that became worse the following day"; TENDERNESS (non-serious) with onset 28Jul2021, outcome "unknown", described as "tenderness of her left upper arm that felt real sensitive"; MUSCLE SPASMS (non-serious) with onset 28Jul2021, outcome "unknown", described as "muscle spasm/pain in her left thigh"; MIGRAINE (non-serious) with onset 28Jul2021, outcome "recovering", described as "The headache was like a migraine that she had for 2-2.5 days, she still has it but its going away". The event "headache that became worse the following day" was evaluated at the physician office visit and emergency room visit.  Additional information: After 4 hours of receiving the Pfizer Covid-19 vaccine, the Caller started experiencing a headache that became worse the following day (states that it felt like a migraine), tenderness of her left upper arm that felt real sensitive, and muscle spasm/pain in her left thigh that felt like a "Charlie Horse". Caller is asking if these are side effects of the Pfizer Covid-19 vaccine. Emergency room and physician office: No.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Facial spasm, SARS-CoV-2 test
Clinical narrative: Facial spasms on my right side just above my cheek bone. Started within hours of my first injection.; 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 left, administration date 25Jun2021 15:00 (Lot number: EW0183) at the age of 59 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Known Allergies" (unspecified if ongoing). Concomitant medication(s) included: HYZAAR; PREVACID. The following information was reported: FACIAL SPASM (non-serious) with onset 25Jun2021, outcome "recovering", described as "Facial spasms on my right side just above my cheek bone. Started within hours of my first injection.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of facial spasm.  Additional information: The patient did not receive any other vaccine in four weeks of covid vaccine. Other medications received by patient within two weeks of covid vaccine: Hyzaar, stool-softener, multiple vitamins, and Prevacid. The patient was not diagnosed with covid-19 prior vaccination but tested for covid post vaccination. The patient had PCR test (Nasal Swab) resulted negative. The patient had known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A female patient received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown); both single dose, for COVID-19 immunisation. The patient's medical history not reported. Concomitant medication included mycophenolate (ongoing). The following information was reported: immune system disorder/immune compromised, with outcome of unknown. Additional information: Patient is immunocompromised. She is on mycophenolate, and has taken both Pfizer COVID-19 shots. Patient not enrolled in a clinical trial. No follow-up attempts possible. No further information expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: developed swollen lymph nodes on the left side of his neck; 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 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Aug2021 11:00 (Batch/Lot number: unknown) at the age of 42 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, Time: around 11:00), administration date: 11Jul2021, for COVID-19 immunization, reaction(s): "arm pain".  The following information was reported: LYMPHADENOPATHY (non-serious) with onset 02Aug2021, outcome "recovering", described as "developed swollen lymph nodes on the left side of his neck".  Additional information: The patient received his second dose of the Pfizer BioNTech Covid 19 vaccine on 01Aug2021 (reported as this past Sunday) on the left side. Since then he has developed swollen lymph nodes on the left side of his neck. He reported it was a little sore last night and he thinks it was a little better, not as big, and still there. It was on the side if his neck where he got the shot. Thinks it was slightly improved. He was told to put a permanent marker around the area and know how big it was and check it in the morning. It was a little sore yesterday but today the lymph node does not feel sore but he still feels it. He wanted to know if this was a normal side effect and if he should be concerned. The patient thinks first dose was on 11Jul2021, left arm, around 11 am. He was unsure of the date of his first dose but states it was 21 days prior to his second dose. Second dose was on Sunday 01Aug2021, left arm, around 11 am. He did have arm pain with his first dose and it only lasted for a day. He was a little worried since the lymph node felt like it was kind of big. The patient was administered vaccine in a pharmacy. No additional vaccines were administered on same date of the Pfizer suspect. The adverse events did not require a visit to emergency room or physician's office. The patient's prior vaccinations (within 4 weeks) were none aside of the first dose. The patient's relevant test were none.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Laboratory test, Mobility decreased
Clinical narrative: Sick; Neither one of us can even lift our heads; 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 female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Jul2021 (Lot number: EW0170) at the age of 74 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: ILLNESS (non-serious), outcome "unknown", described as "Sick"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "Neither one of us can even lift our heads". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of illness. Therapeutic measures were taken as a result of mobility decreased. Additional information: This is the first case out of two cases in which the reporter is reporting for herself. Consumer stated she and her husband went last week to get their first Pfizer vaccine and were both sick. He was 80 and she was 74 and neither one of them could even lift their heads (event captured as verbatim) and plus what was making it worse was they had high temperatures up to 112 and he worked outside and it did not help him any. Consumer stated, yes lab test, not with the shot, did not do. They have to check her all the time because she was going in for surgery (further clarification unknown) next month and so they check because have to see doctors all the time (not clarified further).  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100991743 similar report from same reporter
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Pain in extremity, Paraesthesia
Clinical narrative: Feels like there is pressure up underneath my arm that too and it is coming back on my shoulder blades; left arm went kind of numb and tingly well and it is sore/ Fingers are going numb; left arm went kind of numb and tingly well and it is sore/My arm was like tingling; left arm went kind of numb and tingly well and it is sore/My arm got real sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), administration date 26Jul2021 (Batch/Lot number: unknown) at the age of 44 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: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "Feels like there is pressure up underneath my arm that too and it is coming back on my shoulder blades"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "left arm went kind of numb and tingly well and it is sore/ Fingers are going numb"; PARAESTHESIA (non-serious), outcome "recovered", described as "left arm went kind of numb and tingly well and it is sore/My arm was like tingling"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "left arm went kind of numb and tingly well and it is sore/My arm got real sore".  Additional info: He states here it was a week and a day later and he had pressure under his armpit and he had tingling arm and fingers still on the injection arm and wants to know if that was normal. He states he did call his doctors and they stated that there was really nothing they can do. Doctors said to wait it out for a little while. He states that it kind of went down the side of his arm and then a couple days later it went towards his back or his shoulder blade. He states that had all dissipated but he still had pressure up underneath his arm pit by his joints. He states that he also had numbness in his wrist that feels like carpel tunnel and states his fingers are numb in the middle. He states that was the only thing that was left and it was aggravating, he guesses. Consumer stated, "I had my Pfizer vaccine, my first shot, a week ago, this was past Monday which would have been July, I do not know. When I first got it, like the next day my arm was like tingling and stuff. It got real sore and then tingling started going up and down my whole arm and it was coming back, into my back. when I first got it I had a bunch of tingling and stuff in my arm which I thought was normal and my arm got real sore with that and then it all had gone away. But now my fingers are going numb like I have got still in my 'wrist' and it was still there like I got Carpal tunnel. But I never had that before. Patient stated, I am not going to get my second shot because of my job and I cannot risk having the 'no feeling in my fingers.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Left arm and bottom of hand numbing up/ legs, below the knees felt numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Aug2021 (Lot number: EW0179) at the age of 53 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: HYPOAESTHESIA (non-serious) with onset 03Aug2021, outcome "not recovered", described as "Left arm and bottom of hand numbing up/ legs, below the knees felt numb". Therapeutic measures were not taken as a result of hypoaesthesia. Additional information: The event numbness in toes was on 04Aug2021 not captured as a separate event because hypoaesthesia is already code and the outcome of event  was not recovered so retained in the narrative . The patient did not take any other vaccine within 4 weeks prior to Covid vaccine. No adverse events prior to vaccination. The patient has no illness at the time of vaccination. They did not visit any physician office or any emergency room. The patient did not administer any other vaccine on the same date.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Eating disorder symptom, Parosmia, SARS-CoV-2 test, Taste disorder
Clinical narrative: Can no longer eat any type of meat. It tastes/smells disgusting.; Can no longer eat any type of meat. It tastes/smells disgusting.; Can no longer eat any type of meat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right (Lot number: FA7485) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Graves' disease" (unspecified if ongoing), notes: other medical history Hashitoxicosis Graves' disease; "Hashitoxicosis" (unspecified if ongoing), notes: other medical history Hashitoxicosis Graves' disease; "Covid" (unspecified if ongoing), notes: if covid prior vaccination Yes. The patient took concomitant medications. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, lot number=EW0196,, administration time=01:30 PM,, dose number=1,, vaccine location=Right arm), when the patient was 52 years old, for COVID-19 immunization. The following information was reported: PAROSMIA (non-serious), TASTE DISORDER (non-serious) all with onset 13Jul2021, outcome "not recovered" and all described as "Can no longer eat any type of meat. It tastes/smells disgusting."; EATING DISORDER SYMPTOM (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Can no longer eat any type of meat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of parosmia, taste disorder, eating disorder symptom. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm hurts".  Additional information: His sister said someone told her to flap her arms to relieve the pain, Caller believes his sister received the Pfizer Covid 19 vaccine and asks can she take Advil, instead of flapping her wings? Can she take Advil instead of flapping wings? They didn't tell me to flap my arms, I told my sister to take Advil to reduce the pain. Wife may have had some side effects. Caller states he received his vaccine yesterday at 11:30am. It was the 1st dose of the Pfizer Covid 19 Vaccine. Caller states, "my pain has subsided since last night. The pain was in the Injection site in Left arm. They told me, Pain in the arm should only last a day. They told me to contact my health care provider if it lasts. Consumer calling regarding Pfizer Biontech COVID 19 vaccine reporting an AE for himself mentions with regard to his sister, they said if your arm hurts, you flap your arms like a bird and he thought it might be better to take an Advil and adds isn't that common sense. Adds he assumes someone told his sister to flap her arms. Restates he is calling to ask about taking Advil for his sister; he imagines a doctor told her to flap her arms and she was asking him about that; caller asks for immediate transfer and declined to complete the report. This is a clone report will be created to document the sisters experience. Patient is the sister of the reporter; no initials, no date of birth, no age, no height, no weight, no ethnicity provided; country not confirmed. Reporter is the brother of patient; declined permission to contact; no address, no email   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, Illness, SARS-CoV-2 test
Clinical narrative: Feels awful; Don't feel any good; I got real sick; 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) (Lot number: EW0175) as dose 1, single for covid-19 immunisation. Relevant medical history included: "corona virus", start date: Dec2020 (unspecified if ongoing), notes: I had the corona virus (History) back in December and it was not as bad as taking this vaccine. The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feels awful"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Don't feel any good"; ILLNESS (non-serious), outcome "unknown", described as "I got real sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Consumer stated on call I just wanted to call. I got the vaccine on Tuesday and I had the corona virus (History) back in December and it was not as bad as taking this vaccine. I feel awful. I haven't got the second dose yet. No just the first one. I don't feel any good, I feel awful. I haven't taken the second dose, it's only my first and I got real sick so I don't want to take the second one." Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: she is not feeling "so well."; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 04Aug2021 (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: MALAISE (non-serious), outcome "unknown", described as "she is not feeling "so well."".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Myalgia, Pain in extremity
Clinical narrative: Loss of appetite; Slight muscle ache; Little bit of sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team 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: DECREASED APPETITE (non-serious), outcome "unknown", described as "Loss of appetite"; MYALGIA (non-serious), outcome "unknown", described as "Slight muscle ache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Little bit of sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis
Clinical narrative: a congested head cold; had some congestion last Tuesday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Jul2021 (Batch/Lot number: FA6780) 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 "a congested head cold"; NASAL CONGESTION (non-serious) with onset 03Aug2021, outcome "unknown", described as "had some congestion last Tuesday".  Additional Information: She reported she had some congestion last Tuesday and she is asking can she get the second dose or should she wait. Adds she think she just has a bad head cold unrelated to the vaccine.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Gait disturbance
Clinical narrative: I cant walk. My walking is very bad./I am having a hard time walking/why I can't walk; I just feel bad/I don't feel good. I didn't feel good yesterday; My left side is weak/I get extremely weak/left arm is more weaker than it normally is/my left arm isn't functioning/every time I move around, I get extremely weak and I can't function; 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 female patient received bnt162b2 (BNT162B2) (Lot number: EW0202) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu vaccine, reaction(s): "My walking is very bad".  The following information was reported: GAIT DISTURBANCE (non-serious), outcome "not recovered", described as "I cant walk. My walking is very bad./I am having a hard time walking/why I can't walk"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "I just feel bad/I don't feel good. I didn't feel good yesterday"; ASTHENIA (non-serious), outcome "not recovered", described as "My left side is weak./I get extremely weak/left arm is more weaker than it normally is/my left arm isn't functioning/every time I move around, I get extremely weak and I can't function. I make myself get up".  Additional information: Patient had a Pfizer COVID shot 2 days ago and she didn't feel good. She didn't feel good yesterday but it's worst today, it's like she cannot walk. She was having a hard time walking and her left arm is more weaker than it normally was. Her walking was very bad. her left side was weak. She just felt bad. Patient reacted to other vaccines like flu vaccines. A month getting form that one she had that experience. She was on a walker. After receiving the Pfizer COVID vaccine, the side effects seem to be hanging on. She can't get things accomplished because every time she move around, get extremely weak and can't function. She make herself get up because if she don't, wont be able to get up. She had vaccines before with the flu and sometimes had a reaction, but she don't react like everybody else.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Breast milk discolouration, Off label use, Product use issue
Clinical narrative: Blood pumped in breast milk after 1st dose; Blood pumped in breast milk after 1st dose; Blood pumped in breast milk after 1st dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 37 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: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), BREAST MILK DISCOLOURATION (non-serious), outcome "unknown" and all described as "Blood pumped in breast milk after 1st dose". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Joint swelling, Peripheral swelling
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 47-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0181), at the age of 47, on Aug 4, 2021, single dose, for COVID-19 immunisation. Medical history included asthma (unspecified if ongoing). No concomitant medications reported. The patient experienced joint swelling, fatigue/felt very tired and peripheral swelling; all onset Aug 6, 2021, with outcome of unknown. Patient stated, "my foot is swollen from my ankle to the top of my feet." No therapeutic measures taken as a result of joint swelling, peripheral swelling or fatigue. No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Jul 31, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced a burning sensation, onset 2021, with outcome of unknown. Patient stated, "I got the shot. When I eat a spicy food, it burns inside." No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Vaccination site swelling
Clinical narrative: arm is little numb; I am still having little tingles in my left arm and in my hand; my arm  at injection site it is swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Jul2021 (Lot number: FA7485) at the age of 58 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: HYPOAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "arm is little numb"; PARAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "I am still having little tingles in my left arm and in my hand"; VACCINATION SITE SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "my arm  at injection site it is swollen". Therapeutic measures were taken as a result of hypoaesthesia, paraesthesia, vaccination site swelling.  Additional information: The Tylenol was used as treatment drug. No Investigation Assessment.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Pain
Clinical narrative: terrible acid reflux,I just wanted to die it was so bad; She was in so much pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 (Lot number: ER2613, Expiration Date: 31Jul2021) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes", start date: 2005 (unspecified if ongoing); "she first came down with acid reflux in the 90's, late 90's" (unspecified if ongoing); "She has other sickness" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Metformin for Diabetes, reaction(s): "Acid reflux"; Metformin for Diabetes, reaction(s): "Gastritis". The following information was reported: GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset 2021, outcome "recovered with sequelae" (2021), described as "terrible acid reflux,I just wanted to die it was so bad"; PAIN (non-serious) with onset 2021, outcome "recovered with sequelae" (2021), described as "She was in so much pain". The events "terrible acid reflux,i just wanted to die it was so bad" and "she was in so much pain" were evaluated at the physician office visit and emergency room visit.  Additional Context: She had the vaccine, first injection of Pfizer, on 18Mar2021. After she had the shot she got like a bad case of acid reflux. It was so severe. She was in so much pain. It got better then she started with another round of it. She is trying to cover herself from COVID19. At first caller said she wasn't going to do it and then they started experiencing things. She told her mom they needed to get it. Her mom got the Johnson and Johnson COVID vaccine. Her mom had stuff going on and initially she was fine. Caller's son had Pfizer and he is fine. Once caller made her mind up, she took it. Caller has other stuff going on with her body. She has other sickness and she was a candidate to take it, so she took it.   No follow-up attempts are possible. No further information is expected.