chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Photopsia, Vision blurred
Clinical narrative: Flashes in my left eye and a lot of floaters; cloudiness in my left eye; Flashes in my left eye and a lot of floaters; cloudiness in my left eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 18Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISION BLURRED (non-serious), PHOTOPSIA (non-serious) all with onset 21Apr2021, outcome "not recovered" and all described as "Flashes in my left eye and a lot of floaters; cloudiness in my left eye".  Additional information: It was reported that, the consumer didn't know whether it was related to the vaccine or not, but to check on April 18th, the patient had the vaccine and on April 21, started having flashes in left eye and a lot of floaters that continue the next day and the patient's eye doctor prominently looked, she could not find anything wrong she said it could be a partial vessel, but she couldn't really anything, so, this was last week, so, it's still continuing. Stated that, the patient didn't have flashes as much, but the patient had, they know, cloudiness in left eye, so the patient just wanted to check in, whether it could possibly be related to it, it was right after vaccine, couple of days, so did that condition, that's been concerned or not. Consumer was informed about the role of Pfizer Drug Safety department and Pfizer Medical Information department. Stated that, could the consumer call this number with the extension. LOT#: Consumer stated, EWO164 (not appropriately paraphrased and clarified). Expiration date: Consumer stated, the only thing they have on here was the date the patient received the vaccine, which was on 18Apr2021. NDC# and UPC#: Consumer stated, not, not on the card, they gave. Contact details (mailing address, email address): Stated that, the consumer guessed to call back, one more time. Stated that, further probing could not be done. Limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt really tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "felt really tired".  Additional Information: The reporter's (grandmother) grandson felt really tired today and received the vaccine the same time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, SARS-CoV-2 test
Clinical narrative: second dose muscle pain; second dose tiredness; second dose chills; muscle pain; Tiredness; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 09:30 (Lot number: EW0150, Expiration Date: 31Jul2021) at the age of 29 years as dose 1, single and administered in arm left, administration date 29Apr2021 09:30 (Lot number: EW0172) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset 07Apr2021, outcome "recovered" (08Apr2021), described as "muscle pain"; FATIGUE (non-serious) with onset 07Apr2021, outcome "recovered" (08Apr2021), described as "Tiredness"; CHILLS (non-serious) with onset 07Apr2021, outcome "recovered" (08Apr2021), described as "Chills"; MYALGIA (non-serious) with onset 29Apr2021, outcome "recovered" (30Apr2021), described as "second dose muscle pain"; FATIGUE (non-serious) with onset 29Apr2021, outcome "recovered" (30Apr2021), described as "second dose tiredness"; CHILLS (non-serious) with onset 29Apr2021, outcome "recovered" (30Apr2021), described as "second dose chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: No prior vaccinations (within 4 weeks). No family history. The patient was taking Pfizer COVID 19 vaccine as mother was a nurse kept pestering them. Stated he and his fiancee both got the vaccination on 29Apr2021 and he had symptoms for a day but his fiancee has showed symptoms everyday. She had to take four days off work. Besides the usual swelling and redness at the injection site she has had difficulty breathing and a fast heart beat. Stated he needed to know exactly what to do to help her. Advised caller may provide product specific information but to contact his HCP for medical advice. Caller clarified they both received the first dose 22 days prior on 7Apr2021 at 09:30AM in left arm; then received the second dose on 29Apr2021 at 09:30AM in the left arm. Reported both times he had the same effects. Muscle pain - started two hours before bed and woke up the next day with all of it. Tiredness - same as the muscle pain. Little bit of chills - chills for about two hours at night both nights. Mentioned he did not sleep that well and he noticed the chills more often. Added that is it, nothing much. This happened again the same way, same time and ended the same after the second dose and he was now fully recovered. Vaccine was not Administered at Facility.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperaesthesia, Pain of skin
Clinical narrative: Extreme skin sensitivity over entire body. Unable to wear clothing without pain.; Extreme skin sensitivity over entire body. Unable to wear clothing without pain.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 11:30 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Epinephrine intolerance, notes: epinephrine intolerance. The following information was reported: HYPERAESTHESIA (non-serious), PAIN OF SKIN (non-serious) all with onset 06May2021 16:00, outcome "recovered" (May2021) and all described as "Extreme skin sensitivity over entire body. Unable to wear clothing without pain.". Therapeutic measures were not taken as a result of hyperaesthesia, pain of skin.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the  COVID vaccine. No any other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID19. Since the vaccination, the patient had not been tested for COVID-19. COVID-19 vaccine was administered at Hospital  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Headache, Malaise
Clinical narrative: Felt unwell; Headache; Bone pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Felt unwell"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; BONE PAIN (non-serious), outcome "unknown", described as "Bone pain".  Additional information: A 54-year-old Consumer calls requesting information about the symptoms she experienced after receiving the COVID-19 vaccine from Pfizer. The Consumer reports that after administration of first dose of Pfizers COVID-19 vaccine, she felt unwell, with a headache and bone pain, but no fever or allergies. The Consumer reports that she has not seen a doctor for a diagnosis or management of the symptoms she experienced after administration of Pfizers COVID-19 vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Vomiting
Clinical narrative: migraine; throwing up in the middle of the night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 10Apr2021 (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: MIGRAINE (non-serious), outcome "unknown", described as "migraine"; VOMITING (non-serious), outcome "unknown", described as "throwing up in the middle of the night".  Additional information: Patient want to check if she needs to quarantine herself after the 2nd dose. She got the 1st dose last 10Apr2021 and 2nd dose was on 06May2021. She experienced Migraine and headache in between doses and throwing up in the middle of the night that's why she wasn't able to go to the 2nd dose scheduled for 01May2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70 year-old male patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021514881 same reporter/drug,event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Limb discomfort, Nausea, Pain
Clinical narrative: Covid Arm; Chills; Headache; Nausea; Body Aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 10:00 (Lot number: ER8730) as dose 1,single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing); "High cholesterlol" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Proplene Glycol allergies" (unspecified if ongoing), notes: Known allergy. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: CHILLS (non-serious) with onset 02Apr2021 11:00, outcome "recovering", described as "Chills"; HEADACHE (non-serious) with onset 02Apr2021 11:00, outcome "recovering", described as "Headache"; NAUSEA (non-serious) with onset 02Apr2021 11:00, outcome "recovering", described as "Nausea"; PAIN (non-serious) with onset 02Apr2021 11:00, outcome "recovering", described as "Body Aches"; LIMB DISCOMFORT (non-serious) with onset 02Apr2021 16:00, outcome "recovered" (2021), described as "Covid Arm". Therapeutic measures were not taken as a result of chills, headache, nausea, pain, limb discomfort.  Additional Information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. Prior to vaccination, was the patient diagnosed with COVID-19 was reported as no. Since the vaccination, has the patient been tested for COVID-19 was reported as no. List of any other medications the patient received within 2 weeks of vaccination was vitamins. Does Pfizer have permission to contact the reporter about this event was reported as yes. Does Pfizer have permission to contact your/the patient's healthcare provider about this report was reported as no.Patient received bnt162b2 (BNT162B2), administered in left arm, administration date 28Apr2021 10:00 (Lot number: FWDMI) as dose 2,single for covid-19 immunisation.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood chromogranin A, SARS-CoV-2 test, Tumour marker increased, Tumour marker test
Clinical narrative: My tumor marker Chromogranin A elevated to 518; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 28Dec2020 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "BRCA1" (unspecified if ongoing); "breast cancer" (unspecified if ongoing); "thyroid cancer" (unspecified if ongoing); "colon cancer" (unspecified if ongoing); "carcinoid cancer" (unspecified if ongoing); "Sulpha allergy" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient took concomitant medications. The following information was reported: TUMOUR MARKER INCREASED (non-serious) with onset 06Jan2021, outcome "recovering", described as "My tumor marker Chromogranin A elevated to 518". The event "my tumor marker chromogranin a elevated to 518" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tumour marker increased.  Additional information: The patient was not pregnant at the time of vaccination. Other vaccine in four weeks was reported as no. Other medications in two weeks was reported as yes. No covid prior vaccination and covid tested post vaccination was reported as yes. Covid test type post vaccination was reported as unknown. It was reported that, her tumor marker Chromogranin A elevated to 518 7 days after 1st vaccine and further elevated to 648 within 2 weeks of second vaccine. Subsequent PET scan showed perihilar and mediastinal lymphadenopathy. Bronchoscopy with biopsy of nodes showed reactive lymphocytes. 3 months after vaccine, tumor marker still elevated but down to 125. Stated that, she had a history of carcinoid cancer but no active disease.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot
Clinical narrative: Fatigue; felt hot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 (Lot number: EW0171) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: None. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; FEELING HOT (non-serious), outcome "unknown", described as "felt hot".  Additional information: Patient told he was complete hermit. Patient told he experienced fatigue as well, but felt hot, not chills. Patient also told that he and his wife should get their second dose on 18May2021 but had not confirmed appointments then, stated he might go ahead and get his but was unsure if his wife should. Prior vaccinations (within 4 weeks) patient did not receive any other vaccinations. Patient medical history and family medical history was reported as none. Reporter seriousness for Fatigue and felt hot were reported as unspecified.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: Premature Ventricular Contractions up to a frequency of about 8 PVCs on 1 min for about 3-4 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 15:00 (Lot number: EW0161) at the age of 29 years as dose 1, single and administration date 03May2021 12:15 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VENTRICULAR EXTRASYSTOLES (non-serious) with onset Apr2021, outcome "not recovered", described as "Premature Ventricular Contractions up to a frequency of about 8 PVCs on 1 min for about 3-4 days". The event "premature ventricular contractions up to a frequency of about 8 pvcs on 1 min for about 3-4 days" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of ventricular extrasystoles.  Additional information: The patient had no known allergies. The patient reported that on after first dose, a week after the injection, the patient started Premature Ventricular Contractions up to a frequency of about 8 PVCs on 1 min for about 3-4 days. After that, PVCs frequency started going down to a frequency of about 8 PVCs in one day. After second dose, about 18h after the injection, started increased frequency of PVCs up to a frequency of about 8 PVCs per 1 minute again. 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: After my first and second vaccinations my sinus congestion and seasonal allergies completely disappeared. After first dose I noticed complete clearing of nasal passages; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 (Lot number: EN6198) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "Nasal polyps" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 05Mar2021, outcome "unknown", described as "After my first and second vaccinations my sinus congestion and seasonal allergies completely disappeared. After first dose I noticed complete clearing of nasal passages". Therapeutic measures were not taken as a result of therapeutic response unexpected.  Additional information: The patient didnt receive any other vaccines within 4 weeks prior to the COVID vaccine and not diagnosed with COVID-19. Since the vaccination the patient been tested for COVID-19 After patient first and second vaccinations, the sinus congestion and seasonal allergies completely disappeared. After first dose  noticed complete clearing of nasal passages (I have nasal polyps) and have not needed any seasonal allergy medicine this spring. Feel absolutely fantastic.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Fatigue; muscle aches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Lot number: EW0150) at the age of 39 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 number: ER8735, Lot unknown: False, Dose number: 1, Vaccine location: Left Arm), when the patient was 39 years old, for Covid-19 immunization, reaction(s): "Dizziness", "Fatigue", "Nausea", "Body aches", "Tingling in left hand and left foot"; Bnt162b2 (Product: COVID-19, Lot number: ER8735, Lot unknown: False, Dose number: 1, Vaccine location: Left Arm, notes-(4 days early, started the day after the vaccine)), when the patient was 39 years old, for Covid-19 immunization, reaction(s): "Heavier Period". The following information was reported: FATIGUE (non-serious) with onset 05Apr2021, outcome "recovered" (2021), described as "Fatigue"; MYALGIA (non-serious) with onset 05Apr2021, outcome "recovered" (2021), described as "muscle aches". Therapeutic measures were not taken as a result of fatigue, myalgia.  Additional information-Patient had not taken any other vaccine in four weeks. Patient had no Covid prior vaccination and was not tested for Covid post vaccination  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Left Temple Sunken in after the vaccination.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 12:45 (Lot number: EW0182) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "thyroid slower" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]; PROGYLUTON; EUTIROX; OLLY ACTIVE JOINTS; PROTEINS. Past drug history included: Salmon, reaction(s): "Allergies salmon". Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer BioNTech COVID-19, Lot number: EW0153, Lot unknown: False, Administration date: 16Apr2021, Administration time: 07:15 PM, Dose number: 1, Vaccine location: Right arm), administration date: 16Apr2021, for COVID-19 immunisation. The following information was reported: ADVERSE EVENT (non-serious) with onset 07May2021 13:00, outcome "not recovered", described as "Left Temple Sunken in after the vaccination.". The event "left temple sunken in after the vaccination." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of adverse event. Additional Information: Vaccine Facility Type reported as, Pharmacy or Drug Store. No other vaccine in four weeks. Patient had taken Other medications in two weeks: Prelosec, Progyluton, Eutirox, Olly, Proteins. No treatment AE. No COVID prior vaccination. No COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination site pain
Clinical narrative: Site pain for both doses for less than 48 hours.; Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02May2021 08:30 (Lot number: Ew0167) as dose , 2 single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Chronic UTI" (unspecified if ongoing); "Lumbar Radiculopathy" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Sulfonamide, reaction(s): "Known allergies:Sulfa", notes: Macrobid & sulfa; Macrobid, reaction(s): "known allergies: Macrobid". Vaccination history included: Bnt162b2 (Dose number-01, Lot no-EW0158, Vaccination site-Left arm, Administration Time-08:30Am), administration date: 08Apr2021, when the patient was 49 years old, for Covid-19 immunisation, reaction(s): "Vaccination site pain". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 04May2021, outcome "not recovered", described as "Site pain for both doses for less than 48 hours."; TINNITUS (non-serious) with onset 04May2021, outcome "not recovered", described as "Tinnitus". No follow-up attempts are possible. No further information is expected.  Additional Information: Patient did not have covid prior vaccination. She did not tested for covid post vaccination.  NoFollow-up activities are required, and no further information expected
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness
Clinical narrative: felt dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 10:00 (Lot number: EN6207) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 22Apr2021, outcome "not recovered", described as "felt dizzy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received the first dose Pfizer Covid 19 Vaccine over in the vaccination center, felt dizzy. This is persisting. The paramedics checked out the caller's arterial pressure in patient's left site and everything seemed normal. patient clarifies it first occurred in the vaccination center after receiving the first dose Pfizer Covid 19 Vaccine and after that caller felt nothing until Monday, 03May2021. But since this last Monday, 03May2021, Patient has been feeling really dizzy Its not something only feels in the morning or afternoon or night, it is constant. Patient was worried about that. Patient did not received any other vaccines same date of the Pfizer vaccine. No adverse events occurred following prior vaccinations. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. patient was plan to visit doctor on next Thursday for the adverse events.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Headache; Cold chills; Body aches; numbness in my left arm where I get the shot like a kind of stands from where the shot was till the fingertips; Weak; Fatigue; Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset May2021, outcome "unknown", described as "Headache"; CHILLS (non-serious) with onset May2021, outcome "unknown", described as "Cold chills"; PAIN (non-serious) with onset May2021, outcome "unknown", described as "Body aches"; HYPOAESTHESIA (non-serious) with onset May2021, outcome "unknown", described as "numbness in my left arm where I get the shot like a kind of stands from where the shot was till the fingertips"; ASTHENIA (non-serious) with onset May2021, outcome "unknown", described as "Weak"; FATIGUE (non-serious) with onset May2021, outcome "unknown", described as "Fatigue"; MYALGIA (non-serious) with onset May2021, outcome "unknown", described as "Muscle pain".  Additional information: The manufacturer of Covid-19 Vaccine was unspecified. The patient stated he was just reporting some side effects from his second Pfizer shot. He stated, "I already filled that on the website while I was on hold. I didn't have any take like in suggestion to do anything". You know they just kind of took information any thing they didn't tell me if you know I can take Tylenol or some sort of medicine or something. Consumer further stated, "I already filled the report on the website so I don't think I should filled on another one you know. When asked to probe few questions, consumer stated "I mean if you are filling the report again I mean that will be double filling because I already filled it out I went to website." Date when shot was administered, he stated, "Yesterday"(Confirmed as 4 may and not further clarified). Product details and pharmacy details could not be probed as the consumer was unwilling to complete the report. Hence limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: Headache; Cold chills; Body aches; numbness in my left arm where I get the shot like a kind of stands from where the shot was till the fingertips; Weak; Fatigue; Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset May2021, outcome "unknown", described as "Headache"; CHILLS (non-serious) with onset May2021, outcome "unknown", described as "Cold chills"; PAIN (non-serious) with onset May2021, outcome "unknown", described as "Body aches"; HYPOAESTHESIA (non-serious) with onset May2021, outcome "unknown", described as "numbness in my left arm where I get the shot like a kind of stands from where the shot was till the fingertips"; ASTHENIA (non-serious) with onset May2021, outcome "unknown", described as "Weak"; FATIGUE (non-serious) with onset May2021, outcome "unknown", described as "Fatigue"; MYALGIA (non-serious) with onset May2021, outcome "unknown", described as "Muscle pain".  Additional information: The manufacturer of Covid-19 Vaccine was unspecified. The patient stated he was just reporting some side effects from his second Pfizer shot. He stated, "I already filled that on the website while I was on hold. I didn't have any take like in suggestion to do anything". You know they just kind of took information any thing they didn't tell me if you know I can take Tylenol or some sort of medicine or something. Consumer further stated, "I already filled the report on the website so I don't think I should filled on another one you know. When asked to probe few questions, consumer stated "I mean if you are filling the report again I mean that will be double filling because I already filled it out I went to website." Date when shot was administered, he stated, "Yesterday"(Confirmed as 4 may and not further clarified). Product details and pharmacy details could not be probed as the consumer was unwilling to complete the report. Hence limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache
Clinical narrative: neck issues; Headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Feb2021 (Lot number: EN6203, Expiration Date: 20Jun2021) at the age of 68 years as dose 2, single and administered in arm left, administration date 30Jan2021 11:30 (Lot number: EN9581, Expiration Date: May2021) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Feb2021, outcome "recovered" (Mar2021), described as "Headaches"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "neck issues". Therapeutic measures were not taken as a result of headache.  Additional information: Callers weight was variable from 185-186 pounds. Callers height was close to 6 feet, but at time of report, it was 5 foot 11 inches. He guessed it was variable too. He received the vaccine in his left arm in case it got sore, because he is right handed and she was sitting on his left and it was right to her. He told the caller about having a headache for 1 and a half weeks after the 1st dose and experiencing after the 2nd shot a headache 3 weeks. On 30Jan2021, caller confirmed that this was a Saturday he received his first dose and then his headache started Monday or Tuesday. It was not severe, it was kind of there. Caller moaned. Guessed it was 1 to 1 and a half weeks and kind of went away. Caller added the 30th was a Saturday and he was not positive on when it went away. Caller experienced a headache after the second dose, for 3 weeks, plus or minus a couple days, but a long time. On 20Feb2021, he received his second shot and on the 22 or 23Feb2021, his headache started. He was not positive on the end date. It lasted 3 weeks and all of a sudden it went away. Caller added he was glad because it was getting pretty old. Caller added that he had things going on in his neck and thought perhaps this was what caused the issues. It started 2-3 days then cleared up after awhile and his system mellowed out. Then 2-3 days after the second one, there the headache was again only a little worse than the first, this was not coincidence. So it could not be due to the neck issues. He has not had any more sense then nor had it happened before. Caller could not recall the time of onset of his headache but did add the first headache started in the morning after the vaccine, the 2nd or 3rd day, it was kind of there. Time of Onset (24 hour clock) was unknown. No Emergency Room and Physician Office was required. No relevant tests was done.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm was sore like a regular shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 (Lot number: EN6205) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Crohn's diagnosed", start date: Oct2014 (unspecified if ongoing), notes: verbatim-Crohn's diagnosed Oct 2014.; "hysterectomy", start date: 2016 (unspecified if ongoing). Concomitant medication(s) included: ENTYVIO taken for crohn's disease, start date: Aug2020; LIPITOR taken for blood cholesterol increased, start date: 30Dec2020; TESTOSTERONE, start date: 12Apr2021. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Mar2021, outcome "unknown", described as "her arm was sore like a regular shot".  Additional information: First dose date of Pfizer COVID vaccine 08Mar2021, Lot EN6205, Expiration is unknown. injected intramuscularly on left arm. With both injections, her arm was sore like a regular shot. It was nothing out of the ordinary for a day or two.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain, Pain assessment
Clinical narrative: 8 hours after getting the shot (Friday),My left leg felt like it was this constant cramp and on a scale of 1-10, it was a ten; my whole body hurt really bad; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06May2021 16:15 (Batch/Lot number: unknown) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sjogrens" (unspecified if ongoing); "Gastroparesis" (unspecified if ongoing). Concomitant medication(s) included: LINZESS; NORTRIPTYLINE; MAGNESIUM; B12 [CYANOCOBALAMIN]; VITAMIN D [VITAMIN D NOS]. Past drug history included: Known allergies: amoxacyllin, reaction(s): "Known allergies: Amoxacyllin". Vaccination history included: Bnt162b2 (Dose 1,single, Lot unknown true, Lot unknown reason=Other, Vaccine location=Left arm, ), for COVID-19 immunisation.The following information was reported: MUSCLE SPASMS (non-serious) with onset 07May2021, outcome "not recovered", described as "8 hours after getting the shot (Friday),My left leg felt like it was this constant cramp and on a scale of 1-10, it was a ten"; PAIN (non-serious) with onset 07May2021, outcome "not recovered", described as "my whole body hurt really bad". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of muscle spasms, pain.  Additional information: She stated that I got my shot on Thursday. Advil helped with some of the pain, but it didn't touch the pain in my leg. Saturday wasn't as bad, but I still had to take pain meds to deal with the pain. Sunday (today) it was a bit less in the morning but increased again in the Afternoon. The patient had no prior covid vaccination and was not covid tested post vaccination. She had no allergies and did not get other vaccine in four weeks. The lot number was unknown as she Did not see when she got the shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling
Clinical narrative: Swollen Breasts lasting two weeks after first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2, solution for injection), administered in arm left, administration date 11Apr2021 13:00 (Lot number: ER8730) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VIT D [COLECALCIFEROL]; MAGNESIUM SULFATE; VIT C. The following information was reported: BREAST SWELLING (non-serious) with onset 12Apr2021 12:00, outcome "recovering", described as "Swollen Breasts lasting two weeks after first dose". Therapeutic measures were not taken as a result of breast swelling.  Clinical course: Other vaccine in four weeks and Covid tested post vaccination were no. Concomitant medication included prenatal.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was a little sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 (Lot number: ER8729, Expiration Date: Jul2021) at the age of 60 years as dose 1, single for covid-19 immunisation. Family history included: "son is a diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Apr2021, outcome "recovered" (14Apr2021), described as "arm was a little sore". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated because her son was a diabetic and has underlying health issues and she has to fly next month. Reporter declined to complete report at this time wished to be transferred for her question.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Peripheral swelling
Clinical narrative: Sore throat; I am experiencing some swelling in my arm that I got in which. I know it is normal because I had it with my first one; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: OROPHARYNGEAL PAIN (non-serious), outcome "recovered", described as "Sore throat"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "I am experiencing some swelling in my arm that I got in which. I know it is normal because I had it with my first one".  Additional information: It was reported that the patient had some swelling in arm with first one. Also reported that did not have any problem just sore throat from the first one for a couple of days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test, Dizziness, Flatulence, Nausea
Clinical narrative: Starting 2 days after the first vaccine (April 16, 2021, 3:30 PM) Dizziness started and continued for a week after the vaccine had taken place; Abdomen pain in the upper right quadrant also occurred; Abdomen pain in the upper right quadrant also occurred as well as nausea; Was sent for an Ultrasound and blood work. Both came back negative for anything except a gas bubble in abdomen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 15:30 (Lot number: EW0162) at the age of 18 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TRI LINYAH taken for contraception. The following information was reported: DIZZINESS (non-serious) with onset 18Apr2021, outcome "recovered" (24Apr2021), described as "Starting 2 days after the first vaccine (April 16, 2021, 3:30 PM) Dizziness started and continued for a week after the vaccine had taken place"; ABDOMINAL PAIN UPPER (non-serious) with onset Apr2021, outcome "recovered" (24Apr2021), described as "Abdomen pain in the upper right quadrant also occurred"; NAUSEA (non-serious) with onset Apr2021, outcome "recovered" (24Apr2021), described as "Abdomen pain in the upper right quadrant also occurred as well as nausea"; FLATULENCE (non-serious) with onset Apr2021, outcome "recovered" (24Apr2021), described as "Was sent for an Ultrasound and blood work. Both came back negative for anything except a gas bubble in abdomen". The events "starting 2 days after the first vaccine (april 16, 2021, 3:30 pm) dizziness started and continued for a week after the vaccine had taken place", "abdomen pain in the upper right quadrant also occurred", "abdomen pain in the upper right quadrant also occurred as well as nausea" and "was sent for an ultrasound and blood work. both came back negative for anything except a gas bubble in abdomen" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, abdominal pain upper, nausea, flatulence.  Additional Information: Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness which started and continued for a week, abdomen pain in the upper right quadrant as well as nausea and negative for anything except a gas bubble in the abdomen in the abdomen was resolved on 24Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Starting 2 days after the first vaccine (April 16, 2021, 3:30 PM) Dizziness started and continued for a week after the vaccine had taken place; Abdomen pain in the upper right quadrant also occurred; Abdomen pain in the upper right quadrant also occurred as well as nausea; Was sent for an Ultrasound and blood work. Both came back negative for anything except a gas bubble in abdomen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 15:30 (Lot number: EW0162) at the age of 18 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TRI LINYAH taken for contraception. The following information was reported: DIZZINESS (non-serious) with onset 18Apr2021, outcome "recovered" (24Apr2021), described as "Starting 2 days after the first vaccine (April 16, 2021, 3:30 PM) Dizziness started and continued for a week after the vaccine had taken place"; ABDOMINAL PAIN UPPER (non-serious) with onset Apr2021, outcome "recovered" (24Apr2021), described as "Abdomen pain in the upper right quadrant also occurred"; NAUSEA (non-serious) with onset Apr2021, outcome "recovered" (24Apr2021), described as "Abdomen pain in the upper right quadrant also occurred as well as nausea"; FLATULENCE (non-serious) with onset Apr2021, outcome "recovered" (24Apr2021), described as "Was sent for an Ultrasound and blood work. Both came back negative for anything except a gas bubble in abdomen". The events "starting 2 days after the first vaccine (april 16, 2021, 3:30 pm) dizziness started and continued for a week after the vaccine had taken place", "abdomen pain in the upper right quadrant also occurred", "abdomen pain in the upper right quadrant also occurred as well as nausea" and "was sent for an ultrasound and blood work. both came back negative for anything except a gas bubble in abdomen" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, abdominal pain upper, nausea, flatulence.  Additional Information: Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness which started and continued for a week, abdomen pain in the upper right quadrant as well as nausea and negative for anything except a gas bubble in the abdomen in the abdomen was resolved on 24Apr2021.  No follow-up attempts are possible. No further information is expected.