chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pain
Clinical narrative: full body aches; headache/headachy; fogginess/cloudiness; This is a spontaneous report from a contactable consumer reported for himself that a 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm on 02Apr2021 (Lot Number: EP7533; Expiration Date: 30Jul2021) as SINGLE DOSE for covid-19 immunisation. Patient took the first dose of vaccine on 12MAR2021 (Lot number: EN6208, Expiry date: 30Jun2021), also at age of 46 years old for covid-19 immunization. He didn't have any kind of soreness after the first COVID vaccine. He had no tenderness, no side effects, nothing. For the first time it was about 13:30 in the afternoon and then the second time was he wanted to say about 10:00 am. He had both dose in his shoulders, one was in the left and one was in the right. Vaccine Administered at Military Facility was No. Vaccination Facility was Hospital. Prior vaccination (within 4 weeks prior) was none. The patient medical history and concomitant medications were not reported. Patient had the headaches and also had bad fogginess about 6 hours after the COVID vaccine was administered and the full body aches kicked in the next morning which was about 20 hours after the COVID vaccine was administered and then like he said the body aches went away and the only thing that has really lingered from time to time was the headaches. The body aches started on 03Apr2021 and were over by the following Monday, so 05Apr2021. The cloudiness and the headaches began on 02Apr2021 but he did not have the cloudiness anymore. He got headachy very easily now and he has never experienced that before. He got headaches really easy, they were lingering, but they were not migraines it was just an achy head in the background, in the distance, and he can tell it was something different. The outcome of event headache was not recovered, the outcome of event full body ache was recovered on 05Apr2021,the other event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable consumer (Pfizer employee). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received her first dose of the vaccine, and that the next day she had a sore arm. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: fever of 99.5; tired; arm pain; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer(patient) reported that a male patient of an unknown age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 14Apr2021 for Covid-19 immunization. Medical history and concomitant drug were not provided. Patient had a fever of 99.5 along with being tired and arm pain in Apr2021.  Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Diarrhea really bad; Funny stomach ache/Horrible pain in the middle of her stomach; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 13Apr2021 10:30 (Batch/Lot Number: EW0161) at vaccination age of 63 years old as single dose for covid-19 immunisation. Medical history included ongoing gluten sensitivity (she stopped eating gluten in 1997, maintained a gluten-free diet. She had not been diagnosed with gluten allergy). The patient's concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer Suspect. The patient got the first shot of the Pfizer Vaccine Covid-19 on Tuesday, 13Apr2021 at 10:30. At 12:00 noon she had a funny stomach ache but it got better. Yesterday (14Apr2021) she had the exact same thing happen, funny stomach ache, at about 12:00 noon and she had diarrhea really bad. She felt better this morning (15Apr2021) but now she was having horrible pains in the middle of her stomach, sharp pain in the middle of her stomach. What it's exactly like was she was gluten sensitive and this was the kind of pain she got when she had gluten; and she was wondering was there gluten in this vaccine.  The events did not require a visit to emergency room or physician office. The outcome of event diarrhea really bad was recovered on 14Apr2021. The outcome of other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First shot: Sore arm; This is a spontaneous report from a contactable consumer (patient's sister). A 7-decade-old male patient (reporter's brother) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced "first shot: sore arm" on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021433387 Same reporter/patient/drug, different dose/AE (reporter's brother, second dose)
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Slight headache; This is a spontaneous report from a contactable consumer (patient's sister). A 7-decade-old male patient (reporter's brother) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose for COVID-19 immunization and experienced sore arm.  The patient had a slight headache and took a Tylenol which dealt with it. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021433358 Same reporter/patient/drug, different dose/AE (reporter's brother, first dose);US-PFIZER INC-2021434164 same reporter, product and event, different patient (reporter brother's wife, second dose).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: Slight headache; Right arm was sore where shot was; Little tiredness; Arm swelling after first dose; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Mar2021 10:15 (Batch/Lot Number: EN6198) at the age of 47-years-old as single dose for covid-19 immunization (reported as 'protection for self and others').  Medical history included ongoing Fibroneuropathy, he had it in his feet, started after low back surgery 30 years before in 1991, L5 fractured, had 2 rods and 4 screws into low back, ongoing tremors both arms and hands, mainly left started in high school when first he first noticed, ongoing high blood pressure started in early 2000s, ongoing high cholesterol started in early 2000s, and patient had been on social security disability since 2014 and ongoing. The patient's concomitant medications were not reported. The patient experienced slight headache, right arm was sore where shot was, little tiredness, arm swelling after first dose on 17Mar2021. The outcome of the event headache was recovered on 17Mar2021 with duration of 15 minutes, the outcome of the other events was recovered on 19Mar2021.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable consumer (patient's aunt). A male patient of an unspecified age received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced sore arm. It was reported all reporter knew was that they just complained of a sore arm, but really didn't have much besides that for the second shot. It was pretty mellow. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching, Pain in extremity
Clinical narrative: arm twitching; arm is kind of hurting; This is a spontaneous report from a contactable consumer (patient's wife). A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in left arm at the age of 47-year-old on 12Apr2021 11:45 (Lot Number: EW0158) as single dose for COVID-19 immunisation. Medical history included none. Family Medical History reported Diabetes, heart disease, high cholesterol. There were no concomitant medications. The patient previously took first dose bnt162b2 (Lot Number: EN6199, Route IM, Anatomical Location: Left)) at the age of 47-year-old on 22Mar2021 for COVID-19 immunisation. Caller reporting side effects from Pfizer COVID vaccine that her husband is experiencing. Caller states that her husband had 2nd dose on Monday 12Apr2021 and he is generally ok, his arm is kind of hurting in Apr2021. Caller states her husband arm started twitching today 15Apr2021 (twitching started today around 11AM this morning) and would like to know have other people been reporting this, what this is. Caller states that he caller her about 10:50am this morning so it seems like it has been 72 hours, that the arm twitching started, after the Pfizer COVID vaccine that her husband had on Monday 12Apr2021. Caller states that she is feeling guilty because she had no reaction to the vaccine but her husband is having problems and she made the appointment and made him go get the Pfizer COVID vaccine. No any AEs require a visit to Emergency Room or Physician Office. The outcome of event arm twitching was not recovered. The outcome of event arm is kind of hurting was unknown.  No follow up attempts are needed. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, SARS-CoV-2 test
Clinical narrative: weakness; This is a spontaneous report from a contactable consumer (patient's son). An 81-year-old female patient received bnt162b2 (BNT162B2, Pfizer BioNTech COVID 19 vaccine), dose 2 via an unspecified route of administration on 27Jan2021 (Lot Number: EL1283) as single dose for covid-19 immunisation. Medical history included doesn't sleep. The patient received first dose (Lot Number: EL1284) on 06Jan2021 for covid-19 immunisation. The patient's concomitant medications were not reported. The patient had weakness on 2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test was fine. The outcome was recovered.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable consumer. This consumer (patient mother) reported similar events for four people. This is the first of fourth reports. A patient of unspecified age and gender received BNT162B2 (COVID19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated that her three kids were complaining of sore arms. Outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021433726 same reporter/drug/event, different patient;US-PFIZER INC-2021433725 same reporter/drug/event, different patient;US-PFIZER INC-2021433880 same reporter/drug/event, different patient
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: little bit of muscle soreness on her right arm; little bit of muscle soreness on her right arm; This is a spontaneous report from a contactable consumer (patient's daughter). A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 23Mar2021 17:38 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunization, at the age of vaccination of 59 years old.  Medical history reported as none. Concomitant medications included esomeprazole magnesium (NEXIUM 24HR) taken for antacid from an unspecified start date and ongoing, taking for a couple of years.  The patient experienced little bit of muscle soreness on her right arm (non-serious) on 23Mar2021 with outcome of recovered on 24Mar2021. Reported her mother received the first dose of the Pfizer COVID 19 vaccine on 23Mar2021 at 17:38PM in the right arm. She only had a little bit of muscle soreness on her right arm after the first dose and it went away the day after.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea, Dizziness, Dyspnoea, Neuralgia
Clinical narrative: Almost fainted from struggling to breathe; abdomen swell quite a bit; nerve burning/nerve pain; Diarrhea; Losing some weight; Almost fainted from struggling to breathe; This is a spontaneous report from a contactable consumer (patient). A 61 Years female (no Pregnant) patient received 1st dose of BNT162B2 (Lot number: EN6208) Intramuscular on 25Mar2021 at single dose on Left arm for covid-19 immunization. Medical history was not reported. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications that the patient received within 2 weeks of vaccination was Vitamin C and D and a multi vitamin. Past drug included Allergies to Codeine, Cipro (Cipro gave me central nervous system toxicity). Patient stated that I could immediately taste the shot. Two hours into receiving the shot I could feel it attack my right side. Almost fainted from struggling to breathe. It made the right side of my abdomen swell quite a bit to the point where I felt I almost needed to ice it. It also gave me nerve burning. It has been 3 weeks and I still have some nerve pain from it. Diarrhea. Losing some weight. Unsure if I dare get the second dose. No treatment. Outcome of the event was unknown. Prior to vaccination, patient was not diagnosed with COVID19. Since the vaccination, patient had not been tested for COVID 19.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Almost fainted from struggling to breathe; abdomen swell quite a bit; nerve burning/nerve pain; Diarrhea; Losing some weight; Almost fainted from struggling to breathe; This is a spontaneous report from a contactable consumer (patient). A 61 Years female (no Pregnant) patient received 1st dose of BNT162B2 (Lot number: EN6208) Intramuscular on 25Mar2021 at single dose on Left arm for covid-19 immunization. Medical history was not reported. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications that the patient received within 2 weeks of vaccination was Vitamin C and D and a multi vitamin. Past drug included Allergies to Codeine, Cipro (Cipro gave me central nervous system toxicity). Patient stated that I could immediately taste the shot. Two hours into receiving the shot I could feel it attack my right side. Almost fainted from struggling to breathe. It made the right side of my abdomen swell quite a bit to the point where I felt I almost needed to ice it. It also gave me nerve burning. It has been 3 weeks and I still have some nerve pain from it. Diarrhea. Losing some weight. Unsure if I dare get the second dose. No treatment. Outcome of the event was unknown. Prior to vaccination, patient was not diagnosed with COVID19. Since the vaccination, patient had not been tested for COVID 19.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Pain in extremity, Road traffic accident, X-ray
Clinical narrative: Car accident; she felt fatigued; She had a cough for a few hours; arm soreness/could feel in her left arm where she got the shot; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 16Mar2021 around 15:20 (Lot Number: EN6204) as single dose for covid-19 immunisation. Medical history included ongoing chronic fatigue immune dysfunction,  She was diagnosed in her 30s. She is on no medications for the currently, ongoing herpes. Concomitant medication included valaciclovir 1 tab, 1000mg, oral 2 times a day as needed taken for herpes. The patient experienced arm soreness, could feel in her left arm where she got the shot on 2021, she felt fatigued on 16Mar2021, she had a cough for a few hours on 2021, car accident on 27Mar2021. The patient underwent lab tests and procedures which included X-rays of her neck on 05Apr2021 with unknown result. The outcome of Pain in arm was recovered, fatigue was recovering, the other was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This is a spontaneous report from a contactable consumer for himself.   A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The lot number was illegible and looked like EN6207 and did not clarify which COVID vaccine the lot number was for.  Medical history included tinnitus, where he heard his heartbeat pulse in his ear and hadn't been any improvement in the tinnitus during the check up in last week as of the report. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at age of 44 years old for covid-19 immunisation. The patient's concomitant medications were not reported.  The patient experienced vertigo on 14Apr2021 like he hasn't had before. He did not know if it could be a coincidence that he was experiencing the vertigo after the vaccine on Tuesday(unknown date) or if it was a symptom of the tinnitus he sometimes experiences, his primary care doctor said that vertigo was a symptom of the vaccine.  Vertigo was worse today(15Apr2021) than it was yesterday 14Apr2021, yesterday he had the vertigo for about 5-10 minutes then was fine after the morning. He was sleeping last night and woke up with symptoms of vertigo in the middle of the night. The symptoms are worse today 15Apr2021. Outcome of event was not recovered.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: fever of 99.0; Pain at injections site; fatigue; arm pain; This is a spontaneous report from a non-contactable consumer (Patient). A 54-years-old male patient received first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 54-years-old, via an unspecified route of administration, administered in Arm Left on 14Apr2021 09:30 AM (Lot Number: EW0169) as single dose for covid-19 immunisation. Medical history included myocardial infarction, diabetes mellitus, asthma. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)); insulin aspart (NOVOLOG); carvedilol; atorvastatin; lisinopril; colecalciferol (VITAMIN D 3); vitamin E (VITAMIN E NOS); calcium and multivitamin, gummy vitamin. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Pain at injections site and fatigue on 14Apr2021. The injection site pain started the same day as the injection but the fatigue was more noticeable the day after the injection. Arm pain on 14Apr2021. Last night (15Apr2021) at approximately 9:00 pm symptoms of fatigue and arm pain continued. However, he started to run a fever of 99.0 given him two regular strength Tylenol and fluids. Today (16Apr2021) the fever was resolved in the morning. Event outcome of Pain at injections site and fatigue were not recovered, of fever was recovered on 16Apr2021, of the remaining was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: Body aches; Mild fever 99; This is a spontaneous report from a contactable consumer. A 25-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 11:00 (Batch/Lot Number: EW0162) as SINGLE DOSE for covid-19 immunization, at the age at vaccination of 25 years old.  Medical history included exposure to sars-cov-2 from an unknown date and unknown if ongoing (the reporter's nephew called saying he got tested and had COVID), also reported Exposure to COVID before the first dose of vaccine. The patient's concomitant medications were not reported.  The patient experienced body aches (non-serious) on 14Apr2021 with outcome of recovered on 15Apr2021, mild fever 99 (non-serious) on 14Apr2021 with outcome of recovered on 15Apr2021.  The patient underwent lab tests which included body temperature: 99 on unknown date. Reporter stated he got the Pfizer COVID 19 vaccine shot second dose on Tuesday. However the reporters son had the first shot on Monday and his son had went out with friends over the weekend and the reporter's nephew was there. Reporter stated his son got the shot on Monday. Reporter stated Monday night the reporter's nephew called saying he got tested and had COVID. Reporter stated his son had body aches and a mild fever of 99 and is fine today and is wondering is there a problem? Reporter stated his son went to bed and when he got up he was fine this morning. Body aches: Reporter stated his son had this yesterday afternoon and woke up this morning and was fine. Treatment: Reporter stated no because they were not sure since the thing said not to take anything before. Reporter stated he remembered they said one can take something after but reporter told his son do not take anything since it is better for the vaccine. Reporter stated his son did not get these symptoms until after the shot. Reporter stated the paperwork from Pfizer listed all the symptoms possibly could have and his son has a couple and figured the symptoms were from the vaccine.    No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgraphia, Muscle twitching, Tremor
Clinical narrative: eye twitching; he couldn't write normally; hand shaking; This is a spontaneous report from a contactable consumer reporting for himself.   A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the right arm on 15Mar2021 (Batch/Lot Number: ER8733) as a single dose (at the age of 68 years old) for covid-19 immunisation.  Medical history included blood pressure from an unknown date, and blood glucose increased from an unknown date. Concomitant medication included hydrochlorothiazide, telmisartan (TELMISARTAN + HCT GENOPTIM) taken for blood pressure from 2004 and ongoing at 80-25 mg once a day.  The patient experienced hand shaking on Mar2021 with outcome of recovered, eye twitching on an unspecified date with outcome of unknown, and he couldn't write normally on Mar2021 with outcome of recovered. Further details were reported as follows: he was doing some writing and filling out forms. He was done with two thirds of it and out of the blue, the right hand started shaking and he couldn't write normally.  This lasted about 15 minutes. He sat down for a break and got a little milder, then just went away. Had seen that sometimes with the first Pfizer vaccine, GBS, Gillian Barre syndrome, attacks on the nervous system, like paralysis. He is very concerned. Never had a history of muscle control or anything like this before. Treatment was not received for the events.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm after getting the vaccine; This is a spontaneous report received from a Pfizer sponsored program from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced sore arm after getting the vaccine on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Paraesthesia
Clinical narrative: "pins and needles" sensation, along with a burning sensation in her fingers and her toes; "pins and needles" sensation, along with a burning sensation in her fingers and her toes; pain in joints; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8733) in left arm on 05Apr2021 16:00 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 05Apr2021, the patient experienced "pins and needles" sensation, along with a burning sensation in her fingers and her toes. Pain in joints. She reported that the symptoms were worse in her toes, and had been getting worse over the last week and a half, her regular doctor told her to not get the second dose. No treatment received for the adverse events. Patient did not diagnosed with COVID-19 prior to vaccination, patient had not been tested for COVID-19 since the vaccination.  The outcome of events was not recovered.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain, Pain in extremity
Clinical narrative: he got pain, sore arm and redness after the 1st dose.; he got pain, sore arm and redness after the 1st dose.; he got pain, sore arm and redness after the 1st dose.; This is a spontaneous report received from Pfizer-sponsored program. A contactable male consumer (patient) reported that he received hist first dose of BNT162B2 on 12Apr2021 at single dose for COVID-19 immunisation. Relevant history and concomitant drugs were unknown. The patient mentioned that he got pain, sore arm and redness after the 1st dose. His sister is a nurse so she gave him Ibuprofen and warm compress then it was gone. However he would like to know if this can also happen to his leg or other arm because he is working in the airport and he needs to lift heavy things.  Outcome of the event was resolved. He also mentioned that his neighbor experienced the same side effects like sore arm after getting the vaccine (vaccine detail unknown).    No follow-up attempts are possible, Information about lot/batch number cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Frustration tolerance decreased
Clinical narrative: Cold Sweats; Chills; getting frustrated; This is a spontaneous report from a contactable consumer (patient). male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 14Apr2021 (Lot Number: ER8735) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received dose 1 (Lot: ER2616) on 24Mar2021 for covid-19 immunisation. The patient got the second shot and he had cold sweats in the middle of the day (15Apr2021) and chills on and off, patient was getting frustrated with all of these questions. None treatment was received. The outcome of cold sweats, chills was not recovered, getting frustrated was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable consumer (patient mother). This consumer reported same events for three patients (her 3 kids). This is the 1st of three reports. A patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on an unknown date for Covid-19 immunization. Medical history and concomitant drug were not provided. The consumer reported that her three kids were complaining of sore arms. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021433532 same reporter/drug/event, different patient;US-PFIZER INC-2021433726 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient's parent). Report 4 of 4. This consumer reported for a patient (kid) received BNT162B2 on an unspecific date at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. Caller states that her three kids were complaining of sore arms. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021433532 same reporter/drug/event, different patient;US-PFIZER INC-2021433880 same reporter/drug/event, different patient
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity, Vaccination site mass
Clinical narrative: Pain; a lump down from where the injection site was/ lump in the arm, 4 inches down from the shoulder where she got the shot; her shoulder aches; shoulder aches and the feeling goes into the arm; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 78-years, at single dose in left arm on 03Mar2021 10:00 (Lot number was not reported) for covid-19 immunisation. Medical history included type 2 diabetes that diagnosed about 3 years ago, this year makes 4 years, and she took medications for it. And she was a little overweight, supposed to drop some but gained some back that because of diabetes. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) also at age of 78-years, at single dose in left arm on 02Feb2021 13:00 for covid-19 immunisation and she had no problem with that one. Another Historical Vaccine included flu shots, it just lasted a day or two, maybe that's it, never had problems before. The patient's concomitant medications were not reported. The patient reported side effects from the Pfizer COVID vaccine. Her arm was still bothering her. There was a lump down from where the injection site was and that she kept rubbing it but it won't go away and that she still had pain. She was told she should go to the doctor, but she thought she would call to see what was best to do. She had not a fever, just the lump on the arm, 4 inches down from the shoulder where she got the shot. The patient stated that both Pfizer COVID vaccines were in her left arm, she should have gotten it in the other arm. The patient stated she heard about blood clots and thought she'd better check it out. The patient stated that she had the lump and her shoulder aches; not the shoulder the upper arm. The lump was on the inside and she kept rubbing it but it didn't go away. The patient had the second Pfizer COVID vaccine in the morning around 10:00 AM on 3Mar2021. The pain started the same day on 03Mar2021, then stated that night after midnight and that she thought it would go away. The lump in the arm started a couple of days after the Pfizer COVID vaccine, she thought it was a couple of days but maybe sooner, she didn't pay too much attention. The patient stated the lump felt like it was the size of a nickel, she was pushing to try to feel it and that maybe the lump was a little larger than a nickel. Her shoulder aches and the feeling went into the arm and it started the same week she had the shot but that she didn't pay any attention so is not sure exactly when it started. It was best to check it out with her doctor. The outcome for event pain and vaccination site lump was not recovered, while for remains event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: some hot flash type symptoms that she has not experienced before; This is a spontaneous report from a contactable Nurse reported for herself. A 44-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. About ten days after her first dose of COVID vaccine, she started experiencing some hot flash type symptoms that she has not experienced before. Event took place after use of product. Pregnancy at vaccination time was No. Event outcome was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Confusional state, Dysstasia, Enuresis, Fall
Clinical narrative: could not remember how to stand; would fall down when trying to walk /He was unsteady; would fall down when trying to walk; made no sense and could barely be understood; so sometimes he does not make sense.  Saturday it was exacerbated; peed the bed; This is a spontaneous report from a contactable consumer reporting for 4 patients. This is Report 1 of 4 for reporter's brother-in-law.  A 69 years old male patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation on16Apr2021 10:00. Relevant history included Parkinson's with associated dementia, which comes and goes.  Relevant concomitant drugs included oxybutynin for bladderwhich had been taking for at least over a year, 'ropinirole' for parkinsons, and modafinil 100 mg for focusing; to help her brother-in-laws brain focus. The reporter stated the patient (her brother-in-law) only had the vaccine on Friday (16Apr2021).  He could not remember how to stand, would fall down when trying to walk, peed the bed: callers husband got her brother-in-law up and when he would walk, he would fall down.  They got him up and down to go downstairs to breakfast and have coffee.  He was unsteady.  All of this occurred on 17Apr2021 when they went to wake him up in the morning.  The patient also peed the bed.  The patient just does not always make sense.  On Saturday, he did not make sense.  Sunday, he was better and almost everything was back to normal. He was fine on 19Apr2021; he was himself. The reporter stated that the patient (her brother-in-law) has dementia anyways, so sometimes he does not make sense.  Saturday it was exacerbated, he would ask what to do next or where the bathroom is and this is all stuff that he knows. The patient still had his appetite, the reporter and her husband always say that when her brother-in-law can not eat or does not ask for food then the end is near. The reporter stated the drug Modafinal worked wonderful, he was great on Friday, and he was wonderful before he got the shot. Relevant test was none. The outcome of event made no sense and could barely be understood was resolved. The outcome of other events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: could not remember how to stand; would fall down when trying to walk /He was unsteady; would fall down when trying to walk; made no sense and could barely be understood; so sometimes he does not make sense.  Saturday it was exacerbated; peed the bed; This is a spontaneous report from a contactable consumer reporting for 4 patients. This is Report 1 of 4 for reporter's brother-in-law.  A 69 years old male patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation on16Apr2021 10:00. Relevant history included Parkinson's with associated dementia, which comes and goes.  Relevant concomitant drugs included oxybutynin for bladderwhich had been taking for at least over a year, 'ropinirole' for parkinsons, and modafinil 100 mg for focusing; to help her brother-in-laws brain focus. The reporter stated the patient (her brother-in-law) only had the vaccine on Friday (16Apr2021).  He could not remember how to stand, would fall down when trying to walk, peed the bed: callers husband got her brother-in-law up and when he would walk, he would fall down.  They got him up and down to go downstairs to breakfast and have coffee.  He was unsteady.  All of this occurred on 17Apr2021 when they went to wake him up in the morning.  The patient also peed the bed.  The patient just does not always make sense.  On Saturday, he did not make sense.  Sunday, he was better and almost everything was back to normal. He was fine on 19Apr2021; he was himself. The reporter stated that the patient (her brother-in-law) has dementia anyways, so sometimes he does not make sense.  Saturday it was exacerbated, he would ask what to do next or where the bathroom is and this is all stuff that he knows. The patient still had his appetite, the reporter and her husband always say that when her brother-in-law can not eat or does not ask for food then the end is near. The reporter stated the drug Modafinal worked wonderful, he was great on Friday, and he was wonderful before he got the shot. Relevant test was none. The outcome of event made no sense and could barely be understood was resolved. The outcome of other events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a staff member hit her in her right arm, right arm had been hurting ever since then; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in right arm on 14Apr2021 13:00 (Lot Number: EP7534, Expiration date: Jul2021) as single dose for covid-19 immunisation. Medical history included lupus from 2019. Patient was diagnosed with lupus of the skin and bones in 2019. She said she got infusions for the lupus in her left arm. Concomitant medication(s) was not reported. Patient previously received BNT162B2 (Lot Number: EN6205, Expiration Date: Jun2021) first dose administered in right arm on 26Mar2021 for covid-19 immunisation. On14Apr2021, patient went to work afterwards, and a staff member hit her in her (right) arm (around 6:00PM). She said her right arm had been hurting ever since then. She said she took Tylenol and put alcohol on her arm, but she was still having pain (clarifying her right arm hurts when she tried to lift it). Patient took a Tylenol (Lot Number: 30035519, Expiration Date: Jul2022) 325mg tablet that was dispensed in a little packet from her job (mental hospital). Stated she did not see a NDC Number, providing number SDC002. Patient stated when got home from work, she applied Alcohol to her right arm. She stated she was not sure if the first character in the Alcohol 50% Lot Number was an "8" or "0". Reported she was right-handed and had got both COVID-19 Vaccine doses in her right arm. She said she didn't use her left arm because she got infusions in her left arm for her lupus of the skin and bone. Patient stated she had no problem with the COVID-19 Vaccine, until she was hit in the arm she received the COVID-19 Vaccine in. A sample of the product was available to be returned, if requested. The event outcome was not recovered.  No follow-up attempts are possible. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unknown age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on an unknown date for Covid-19 immunization. Medical history was reported as "none". Concomitant drug was not provided. Patient had her vaccine, but had nothing but a sore arm. Patient stated that a sore arm was not a big deal. Outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; fatigue; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for a male patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on an unknown date for Covid-19 immunization. Medical history and concomitant drug were not provided. Patient had nothing but a sore arm and some fatigue. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: left underarm is swollen up really bad; This is a spontaneous report from a contactable consumer (patient).   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 12Apr2021 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Mar2021(Lot #: EW0161, Anatomical Location: Arm Left) for covid-19 immunization. The patient medical history and concomitant medications were not reported.  On 14Apr2021, he noticed that his left underarm is swollen up really bad, he first noticed it yesterday(14Apr2021) but it could have been there longer. He put a cold compress on it because he was not sure. Outcome for event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: hit her like a ton of bricks; horrible for her; This is a spontaneous report from a contactable consumer for doctor's associate.   This is Report 4 of 6.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) at single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2 for covid-19 immunisation on unknown date. The patient medical history and concomitant medications were not reported.  The patient experienced hit her like a ton of bricks, but it was her second, not her first. It was horrible for her on her second, it was really horrible. Outcome for events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm hardly hurt; This is a spontaneous report from a female contactable consumer (patient) reported for herself. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced arm hardly hurt (non-serious) on an unspecified date with outcome of unknown. Caller stated that she had the second dose about 16 days ago and really didn't have any symptoms at all. Caller stated that her arm hardly hurt.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Cough, Headache, Malaise
Clinical narrative: achy/She had body aches; general malaise; The general achiness has been happening on and off consistently since she was rear-ended. It is in her neck and her back; The general achiness has been happening on and off consistently since she was rear-ended. It is in her neck and her back; Coughing; Left arm soreness; Little cold; muscle achiness; She had gained some Covid weight; abdominal discomfort like pain; ribs feel almost bruised; headache; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 56-years, at single dose in left arm on 06Apr2021 (Lot number: EN8732 or ER8732 (unsure)) for covid-19 immunisation.  Medical history included ongoing Chronic fatigue immune dysfunction. She was diagnosed in her 30s. She was on no medications for the currently. And ongoing herpes. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 56-years, at single dose in left arm on 16Mar2021 (Lot number: EN6204) for covid-19 immunisation and she experienced fatigued and Cough. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. Concomitant medication included valaciclovir taken for herpes outbreak.  The patient experienced ribs feel almost bruised (musculoskeletal chest pain) on 12Apr2021, headache 18 hours after the shot (in Apr2021), achy/she had body aches (pain) on an unspecified date, general malaise on an unspecified date, general achiness has been happening on and off consistently since she was rear-ended and it was in her neck and her back (back pain and neck pain) on an unspecified date, abdominal discomfort like pain on 15Apr2021, coughing on an unspecified date, left arm soreness on an unspecified date, little cold on an unspecified date, muscle achiness on unspecified date; She had gained some Covid weight on an unspecified date. The patient underwent lab tests and procedures which included X-rays of her neck after a car accident with unknown result on an unknown date. She took Tylenol and Excedrin Migraine pill for headache. It was reported that the adverse events did not result in a visit to Emergency room or Physician Office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Events outcome was unknown.  No follow-up attempts are needed. No further information is expected.