chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness, Testicular pain, Testicular swelling
Clinical narrative: I am experiencing pain in my testicles. Very sore and tender to touch. appear to be somewhat swollen.; I am experiencing pain in my testicles. Very sore and tender to touch. appear to be somewhat swollen.; I am experiencing pain in my testicles. Very sore and tender to touch. appear to be somewhat swollen.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old male patient received bnt162b2 (BNT162B2), administration date 18May2021 10:00 (Batch/Lot number: unknown) at the age of 26 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 ({product=COVID 19, lot_unknown=True,, administration_date=27/Apr/2021,, dose_number=1}]), administration date: 27Apr2021, for COVID-19 immunization. The following information was reported: TESTICULAR PAIN (non-serious), TENDERNESS (non-serious), TESTICULAR SWELLING (non-serious) all with onset 18May2021 20:00, outcome "recovering" and all described as "I am experiencing pain in my testicles. Very sore and tender to touch. appear to be somewhat swollen.". It was unknown if therapeutic measures were taken as a result of testicular pain, tenderness, testicular swelling.  Additional Information: The most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient was experiencing pain in testicles. Very sore and tender to touch. appear to be somewhat swollen. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First dose: vaccinated arm hurt and was really sore; she couldn't use her arm or lift anything; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 09:00 (Lot number: ER8729) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hernia surgery" (unspecified if ongoing), notes: Surgeries: She had a hernia surgery 10 years ago; "arthritic" (unspecified if ongoing), notes: She has joint problems with her toes/One of her toes sometimes feels like it is a little arthritic; "lack vitamin D" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3 taken for vitamin d deficiency; TURMERIC [CURCUMA LONGA] taken for arthralgia. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07Apr2021, outcome "unknown", described as "First dose: vaccinated arm hurt and was really sore; she couldn't use her arm or lift anything".  Additional information: Patient says the first shot of Pfizer was excruciatingly painful in her vaccinated arm. For the first shot 07Apr2021 she had a really sore arm. She again reiterates her arm hurt with the first shot. She could not use her arm. She could not lift anything nor pick up a cup. Her painful arm after the first shot lasted at least for a couple of days. Vitamin D3; 8,000 IU (200mcg), every other day. She says she has been taking this vitamin for a very long time. Turmeric, 1,000 mg probably every other day. No investigation assessment. She says the two different pieces between the first round and second round of symptoms are that her hair does not hurt like it did with the first round, but the vaccinated arm hurts. Second dose on 28Apr2021 at about 9:00am, LOT number EW0176, left arm. Prior vaccinations (within 4 weeks) were none. Allergies: She mentions she gets sneezing fits with dust. She says there are times of the year when she was sneezing but it was not enough to make a note of it, she was just aware of it.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021569201 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 43-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on May 18, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced vaccination site pain (experienced soreness at the injection site), axillary pain (pain under her left arm/pain in armpit) and breast pain (pain to the left-side of breast), with outcome of unknown. Additional information: Patient received the Pfizer COVID-19 vaccine on May 18, 2021. About 6-8 hours after the vaccination, she experienced soreness at the injection site, pain under her left arm and pain to the left-side of her breast. She asked if breast pain was normal. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain on the right side after my COVID Vaccine.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Pain on the right side after my COVID Vaccine.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperaesthesia, Pain, Pain in extremity, Temperature intolerance
Clinical narrative: I felt extremely achy all over (including inside my body/torso); also felt very sensitive to hot and cold surfaces and touching or making contact with things in general.; also felt very sensitive to hot and cold surfaces and touching or making contact with things in general.; chills; arm sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11May2021 09:00 (Lot number: ER8736) at the age of 24 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CONCERTA; IBUPROFEN. Vaccination history included: Bnt162b2 (Dose 1, Single; at 09:00; Batch/Lot No.EW0162; Administration site: Left arm), administration date: 20Apr2021, when the patient was 24 years old, for COVID-19 immunization, reaction(s): "sore ram". The following information was reported: PAIN (non-serious) with onset 11May2021 20:45, outcome "recovered" (2021), described as "I felt extremely achy all over (including inside my body/torso)"; TEMPERATURE INTOLERANCE (non-serious), HYPERAESTHESIA (non-serious) all with onset 11May2021 20:45, outcome "recovered" (2021) and all described as "also felt very sensitive to hot and cold surfaces and touching or making contact with things in general."; CHILLS (non-serious) with onset 11May2021 20:45, outcome "recovered" (2021), described as "chills"; PAIN IN EXTREMITY (non-serious) with onset 11May2021 20:45, outcome "recovered" (2021), described as "arm sore". Therapeutic measures were not taken as a result of pain, temperature intolerance, hyperaesthesia, chills, pain in extremity.  Additional information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11May2021 at 20:45, the patient experienced "Side effects weren't unexpected, but wanted to report that I felt extremely achy all over (including inside my body/torso) and also felt very sensitive to hot and cold surfaces and touching or making contact with things in general. Symptoms on-set about 11-12 hours after second shot and eased off by another 16-ish hours after they began. No coughing or anything, just chills and very strong aches. Also, my arm was less sore after I received the 2nd shot than it was for my first shot.". The patient did not receive any treatment for the reported event. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of all events was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Photosensitivity reaction
Clinical narrative: Experiencing sun sensitivity; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19May2021 13:00 (Batch/Lot number: unknown) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INCASSIA; ZYRTEC [LEVOCABASTINE HYDROCHLORIDE]. The following information was reported: PHOTOSENSITIVITY REACTION (non-serious) with onset 19May2021, outcome "not recovered", described as "Experiencing sun sensitivity". Therapeutic measures were not taken as a result of photosensitivity reaction.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The adverse event did not result in doctor or other healthcare professional office/clinic visit/ emergency care visit.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: On the evening of the first vaccination, a pronounced ringing in my right ear was experienced. It has now persisted since the initial vaccination.; 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 male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Apr2021 14:00 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single and administration date 19May2021 10:30 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gluten intolerance" (unspecified if ongoing); "Lactose intolerance" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 28Apr2021 19:00, outcome "not recovered", described as "On the evening of the first vaccination, a pronounced ringing in my right ear was experienced. It has now persisted since the initial vaccination.". Therapeutic measures were not taken as a result of tinnitus.  Additional information: The event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lethargy, Pain
Clinical narrative: Lethargic; tremendously achy and having body pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "rheumatoid arthritic" (ongoing). Concomitant medication(s) included: METHOTREXATE SODIUM taken for rheumatoid arthritis. The following information was reported: LETHARGY (non-serious), outcome "unknown", described as "Lethargic"; PAIN (non-serious), outcome "unknown", described as "tremendously achy and having body pains". The events "lethargic" and "tremendously achy and having body pains" were evaluated at the physician office visit.  Additional information: The reporter did not have any further information on the patient.  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021577714 same reporter/drug/event, diff patients
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Hypoaesthesia, Paraesthesia, Tenderness
Clinical narrative: Felt some numbing/ numbness; Some tenderness on all the parts I felt heat on yesterday; Like a small tingle; Little off on right side; Felt heat rushing in/ the heat went throughout my shoulder, neck, face, head, half way down my back. All on the right side where I got the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19May2021 15:00 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa. There were no concomitant medications. The following information was reported: FEELING HOT (non-serious) with onset 19May2021 15:00, outcome "recovering", described as "Felt heat rushing in/ the heat went throughout my shoulder, neck, face, head, half way down my back. All on the right side where I got the vaccine"; HYPOAESTHESIA (non-serious) with onset 20May2021, outcome "recovering", described as "Felt some numbing/ numbness"; TENDERNESS (non-serious) with onset 20May2021, outcome "recovering", described as "Some tenderness on all the parts I felt heat on yesterday"; PARAESTHESIA (non-serious) with onset 20May2021, outcome "recovering", described as "Like a small tingle"; FEELING ABNORMAL (non-serious) with onset 20May2021, outcome "recovering", described as "Little off on right side". Therapeutic measures were not taken as a result of feeling hot, hypoaesthesia, tenderness, paraesthesia, feeling abnormal.  Additional information: The patient reported that the heat she felt the day before never flowed to her whole body, and was present only to the areas that she mentioned. She felt that it was very odd how the flow of heat only rushed to certain areas. Patient felt completely fine. She had no cold like symptoms at all. She was just a little off on her right side. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Tinnitus
Clinical narrative: Tinnitus; felt exhausted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 05Mar2021 (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: TINNITUS (non-serious), outcome "unknown", described as "Tinnitus"; FATIGUE (non-serious), outcome "unknown", described as "felt exhausted". Therapeutic measures were taken as a result of tinnitus.  Additional information- It was reported that Physician gave him steroids for the management of the Tinnitus and it did not worked.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021575706 Same reporter/drug/event for different patients
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: my arm was less sore after I received the 2nd shot than it was for my first shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 09:00 (Lot number: EW0162) at the age of 24 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CONCERTA; IBUPROFEN. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered", described as "my arm was less sore after I received the 2nd shot than it was for my first shot". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Patient arm was less sore after received the 2nd shot than it was for first shot. She did not have known allergies. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: She stated that when she received the first dose, she was "sick pretty bad too".; 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 54 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "She stated that when she received the first dose, she was "sick pretty bad too".".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, SARS-CoV-2 antibody test
Clinical narrative: chills; headache; lethargic; This is a spontaneous report from a contactable consumer, the patient. This is the first of two reports. An 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 15:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Oct2020 (unspecified if ongoing), notes: previously had Covid in Late October, Prior to vaccination, was the patient diagnosed with COVID-19 : Yes. There were no concomitant medications. The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "chills"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache"; LETHARGY (non-serious) with onset 2021, outcome "recovered" (2021), described as "lethargic". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, headache, lethargy.  Additional information: Patient had no known allergies to food, medications or other products. Patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021, after the first vaccine, patient experienced chills, a headache and was lethargic and it lasted for 24 hours. On an unknown date in Apr2021, the patient underwent antibody test and the result was positive for short term and long-term antibodies. The clinical outcome of the events chills, a headache and was lethargic were recovered on an unknown date in 2021.The patient did not receive treatment for the reported events.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Pain, Throat irritation
Clinical narrative: She looks tired; Itchy throat; Pain from Hips to Shoulder; Headache; She is feeling really bad.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 12 year-old female patient received bnt162b2 (BNT162B2), administration date 20May2021 08:50 (Lot number: EW0183) at the age of 12 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN B. The following information was reported: FATIGUE (non-serious) with onset 20May2021, outcome "not recovered", described as "She looks tired"; THROAT IRRITATION (non-serious) with onset 20May2021, outcome "not recovered", described as "Itchy throat"; PAIN (non-serious) with onset 20May2021, outcome "not recovered", described as "Pain from Hips to Shoulder"; HEADACHE (non-serious) with onset 20May2021, outcome "not recovered", described as "Headache"; FEELING ABNORMAL (non-serious) with onset 20May2021, outcome "unknown", described as "She is feeling really bad.". Therapeutic measures were not taken as a result of fatigue, throat irritation, pain, headache, feeling abnormal.  Additional information: Reporter stated, "Called because today we took my niece for the vaccine this morning 8.50 in the morning and she was feeling really bad right now she has side effect she was feeling pain over the hips from the hips to the top from the hips to the shoulders and also she was feeling some Headache Off course and itching in the throat and what she was feeling right now she was tired off course she was saying pain is going back and forward sometimes its really bad she looks tired"  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had neck pain/sore neck, and myalgia/muscle pain in neck, with outcome of unknown. Additional information: The reporter wanted to know if a sore neck was a side effect of the vaccine. She was experiencing pain  from the first dose. She had muscle pain in her neck, and wondered if it was a side effect of the first dose of the vaccine. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: She has since developed a lump under her skin on the top of her head.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 39 year-old female patient received bnt162b2 (BNT162B2), administration date 10May2021 (Batch/Lot number: unknown) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SKIN MASS (non-serious) with onset May2021, outcome "unknown", described as "She has since developed a lump under her skin on the top of her head.".  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Headache; Fatigue; Muscle aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 20May2021 (Batch/Lot number: unknown) at the age of 32 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 20May2021, outcome "recovering", described as "Headache"; FATIGUE (non-serious) with onset 20May2021, outcome "recovering", described as "Fatigue"; MYALGIA (non-serious) with onset 20May2021, outcome "recovering", described as "Muscle aches". Therapeutic measures were not taken as a result of headache, fatigue, myalgia.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia
Clinical narrative: I can barely stay up all day; extremely tired to the point of exhaustion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Apr2021 08:30 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Fibroids" (unspecified if ongoing). Concomitant medication(s) included: LUPRON; HUMULINE. Vaccination history included: Bnt162b2 (1st dose, administration time=09:00 AM), administration date: 13Mar2021, when the patient was 43 years old, for COVID-19 immunization. The following information was reported: HYPERSOMNIA (non-serious) with onset 04Apr2021 12:00, outcome "not recovered", described as "I can barely stay up all day"; FATIGUE (non-serious) with onset 04Apr2021 12:00, outcome "not recovered", described as "extremely tired to the point of exhaustion". The events "i can barely stay up all day" and "extremely tired to the point of exhaustion" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of hypersomnia, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since vaccination, the patient had not been tested for covid-19. Device date was reported as 21May2021. Other medications in two weeks: Lupron and Humlin Insulin. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Fall, Fatigue
Clinical narrative: From Tuesday until now he is been puking and he hasn't left the bed at all; Diarrhea; Just don't wanna eat, no appetite , drinking lots of water.; he can't get out of bed; he is not eating anything; they told me that he get up and fall; his stomach is hurting real bad; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 13May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Verbatim: 1st dose of covid-19.), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 13May2021, outcome "unknown", described as "Tiredness"; VOMITING (non-serious) with onset 18May2021, outcome "unknown", described as "From Tuesday until now he is been puking and he hasn't left the bed at all"; DIARRHOEA (non-serious) with onset 18May2021, outcome "unknown", described as "Diarrhea"; DECREASED APPETITE (non-serious) with onset 18May2021, outcome "unknown", described as "Just don't wanna eat, no appetite , drinking lots of water."; HYPOKINESIA (non-serious) with onset 18May2021, outcome "unknown", described as "he can't get out of bed; he is not eating anything"; FALL (non-serious) with onset 18May2021, outcome "unknown", described as "they told me that he get up and fall"; ABDOMINAL PAIN UPPER (non-serious) with onset 18May2021, outcome "unknown", described as "his stomach is hurting real bad".  Additional information: Patient got this the Pfizer shot a week ago, today will be a week, the second shot a week ago, on Thursday (confirmed as 13May2021) and he can't get out of bed until Saturday (confirmed as 15May2021) and then from Tuesday until now he is still in bed we concerned of, have this part he is not eating anything and drink up water though. When paraphrased, reporter stated, "This week from Tuesday until now he is been puking and he hasn't left the bed at all and he is not eating right and they told me that he get up and fall and he is not eating and he is drinking up water though and his stomach is hurting real bad. Is the side effects supposed to last that long? How long the side effect can last on the second shot of Pfizer (confirmed as Pfizer COVID vaccine). Reporter stated, "He don't want call any doctor, my problem, my dad wouldn't let me call the doctor". Reporter stated, "one side effect is tiredness, he still has that too, vomiting, diarrhea and just don't want to eat, no appetite, drinking lots of water."  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypokinesia, Vomiting
Clinical narrative: From Tuesday until now he is been puking and he hasn't left the bed at all; Diarrhea; Just don't wanna eat, no appetite , drinking lots of water.; he can't get out of bed; he is not eating anything; they told me that he get up and fall; his stomach is hurting real bad; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 13May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Verbatim: 1st dose of covid-19.), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 13May2021, outcome "unknown", described as "Tiredness"; VOMITING (non-serious) with onset 18May2021, outcome "unknown", described as "From Tuesday until now he is been puking and he hasn't left the bed at all"; DIARRHOEA (non-serious) with onset 18May2021, outcome "unknown", described as "Diarrhea"; DECREASED APPETITE (non-serious) with onset 18May2021, outcome "unknown", described as "Just don't wanna eat, no appetite , drinking lots of water."; HYPOKINESIA (non-serious) with onset 18May2021, outcome "unknown", described as "he can't get out of bed; he is not eating anything"; FALL (non-serious) with onset 18May2021, outcome "unknown", described as "they told me that he get up and fall"; ABDOMINAL PAIN UPPER (non-serious) with onset 18May2021, outcome "unknown", described as "his stomach is hurting real bad".  Additional information: Patient got this the Pfizer shot a week ago, today will be a week, the second shot a week ago, on Thursday (confirmed as 13May2021) and he can't get out of bed until Saturday (confirmed as 15May2021) and then from Tuesday until now he is still in bed we concerned of, have this part he is not eating anything and drink up water though. When paraphrased, reporter stated, "This week from Tuesday until now he is been puking and he hasn't left the bed at all and he is not eating right and they told me that he get up and fall and he is not eating and he is drinking up water though and his stomach is hurting real bad. Is the side effects supposed to last that long? How long the side effect can last on the second shot of Pfizer (confirmed as Pfizer COVID vaccine). Reporter stated, "He don't want call any doctor, my problem, my dad wouldn't let me call the doctor". Reporter stated, "one side effect is tiredness, he still has that too, vomiting, diarrhea and just don't want to eat, no appetite, drinking lots of water."  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Magnetic resonance imaging, Migraine
Clinical narrative: migraine; 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), administration date 11Apr2021 09:00 (Lot number: EW0150) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Verbatim: The patient took her 1st dose of Pfizer vaccine Lot no.EN6203 in her left arm.), for covid-19 immunization. The following information was reported: MIGRAINE (non-serious) with onset 11Apr2021 15:00, outcome "unknown", described as "migraine". The event "migraine" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller stated that after vaccination she having the "throbbing headache and it has not stopped since then. This is not a regular headache; I call it a migraine but I don't know if it's that. It's a chronic, vicious, burning, throbbing headache, it's everyday my whole head cap, eyebrows, I'm a lawyer and it gets worse as the day goes by the weather make worse. I'm at a lost, I had a CAT scan and MRI, I've seen my primary physician, ER doctor, Neurologist and I have follow ups with the Neurologist, I don't suffer from Migraines. I never had COVID. I've heard of people who had the headache/migraine for a long time but these were people who have a history of migraines, which I don't have. This is scary and disheartening. I don't know what to do, is there any assistance hotline for people having a negative effect"? I had the vaccine 6 weeks ago & I have had chronic migraine daily for 6 weeks. I do not suffer migraine. Consumer further stated, "First of all before I answer your question is someone going to help me. I wanted to give you information for you for file. I want to know there is a number at Pfizer that I can speak to someone with scientific knowledge because possibly it is 6 weeks." Consumer stated, "I can't answer your questions because I have headache. It's not easy to understand on the phone."  No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Headache, Malaise
Clinical narrative: pain in the arm at the site of injection; really tired; weak; Nausea; feeling unwell; Diarrhea; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2), administration date 19May2021 (Lot number: EW0175) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain in the arm at the site of injection"; FATIGUE (non-serious), outcome "unknown", described as "really tired"; ASTHENIA (non-serious), outcome "unknown", described as "weak"; HEADACHE (non-serious) with onset 20May2021, outcome "recovered", described as "Headache"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; MALAISE (non-serious), outcome "unknown", described as "feeling unwell"; DIARRHOEA (non-serious), outcome "not recovered", described as "Diarrhea". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, asthenia, headache, nausea, malaise, diarrhoea.  Additional information: The reporter stated that his son got his first shot yesterday and so far he of course has pain in the arm at the site of injection but he is really tired and rather weak he had minor headache this morning, he has diarrhea and little bit nausea and generally just feeling unwell, he does not have a fever but she thought maybe she should report that just because this was his first shot and she thought normally it start getting that's stuff on the second shot. The headache was gone away he was still very tired, and the diarrhea was recent.  No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: pain in the arm at the site of injection; really tired; weak; Nausea; feeling unwell; Diarrhea; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2), administration date 19May2021 (Lot number: EW0175) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain in the arm at the site of injection"; FATIGUE (non-serious), outcome "unknown", described as "really tired"; ASTHENIA (non-serious), outcome "unknown", described as "weak"; HEADACHE (non-serious) with onset 20May2021, outcome "recovered", described as "Headache"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; MALAISE (non-serious), outcome "unknown", described as "feeling unwell"; DIARRHOEA (non-serious), outcome "not recovered", described as "Diarrhea". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, asthenia, headache, nausea, malaise, diarrhoea.  Additional information: The reporter stated that his son got his first shot yesterday and so far he of course has pain in the arm at the site of injection but he is really tired and rather weak he had minor headache this morning, he has diarrhea and little bit nausea and generally just feeling unwell, he does not have a fever but she thought maybe she should report that just because this was his first shot and she thought normally it start getting that's stuff on the second shot. The headache was gone away he was still very tired, and the diarrhea was recent.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Cluster headache
Clinical narrative: cluster headaches every day since approximately one week after shot.This is four months straight of daily cluster headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Feb2021 12:15 (Batch/Lot number: unknown) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "history of cluster headaches every few years .They usually last for about a week", start date: 1986 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, location : arm Left, Lot: Obscured by other product labelling), administration date: 08Jan2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: CLUSTER HEADACHE (non-serious) with onset 15Feb2021 12:00, outcome "not recovered", described as "cluster headaches every day since approximately one week after shot.This is four months straight of daily cluster headaches". Therapeutic measures were taken as a result of cluster headache.  Additional information: Patient didnot receive any other vaccine in four weeks and didnot received any other medications in two weeks. Patient had no Covid, prior vaccination and had not been covid tested, post vaccination. Treatment medication included sumatrin.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D [VITAMIN D NOS].  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Medical history was not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Sore arm, 12 hours first dose. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness, Pain in jaw, SARS-CoV-2 test, X-ray
Clinical narrative: After two weeks, experienced pain and tightening of left jaw.; After two weeks, experienced pain and tightening of left jaw.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 30Apr2021 12:05 (Batch/Lot number: unknown) at the age of 71 as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing), notes: other medical history: Arthritis; "Osteoarthritis" (ongoing), notes: Five years ago; "High Cholesterol" (ongoing), notes: Decades ago, can not tolerant to statins; "can not tolerant to statins" (unspecified if ongoing), notes: can not tolerant to statins; "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: PAROXETINE taken for anxiety, start date: 2020. Past drug history included: Allergies: augmentin, reaction(s): "Drug allergy".  The following information was reported: PAIN IN JAW (non-serious), MUSCLE TIGHTNESS (non-serious) all with onset 07May2021, outcome "not recovered" and all described as "After two weeks, experienced pain and tightening of left jaw.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in jaw, muscle tightness.  Additional Information: Patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EW0167), dose 2 intramuscularly, administered in Arm Left on 21May2021 10:50 as dose 2, single for covid-19 immunisation. The patient did not take any other vaccine in four weeks. Prior to the vaccination, the patient was not diagnosed with Covid-19. Other medications received within 2 weeks of vaccination: Paroxitine-10 mg. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19. Device Date : 21May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Pain, Pain in extremity
Clinical narrative: extremely soar right arm; weak all over body; body aches; significant headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 21Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D NOS; VIT C. Vaccination history included: Bnt162b2 (Sore arm, 12 hours first dose), when the patient was 41 years old, for COVID-19 immunisation, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21Apr2021, outcome "recovered" (2021), described as "extremely soar right arm"; ASTHENIA (non-serious) with onset 21Apr2021, outcome "recovered" (2021), described as "weak all over body"; PAIN (non-serious) with onset 21Apr2021, outcome "recovered" (2021), described as "body aches"; HEADACHE (non-serious) with onset 21Apr2021, outcome "recovered" (2021), described as "significant headache". Therapeutic measures were not taken as a result of pain in extremity, asthenia, pain, headache.  Additional information: . The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.