chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not doing well since then; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (060820).  A 59 year-old female patient received bnt162b2 (BNT162B2), administration date 09Sep2021 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 IMMUNIZATION. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "not doing well since then".  Additional information: The patient took Ibrance 125 mg daily for 21 days off 7 with daily Letrozole. Patient reported her leg weakness has gotten worse to the point of her husband has had to help her up and down the stairs, she had dry mouth, mouth sores that were cracking open-she was prescribed nystatin for possible thrush. She had general weakness all over with tiredness and fatigue, and easily falling asleep. As well as tapering down her steroid use and was unsure what symptoms were from what.  was aware of all side effects per patient.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Pain in extremity
Clinical narrative: Loss of appetite; tiredness; sore arm; headache; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 13Sep2021 04:45 (Batch/Lot number: unknown) at the age of 21 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU, administration date 02Sep2021. Past drug history included: Ibuprofen, reaction(s): "allergies". The following information was reported: DECREASED APPETITE (non-serious) with onset 14Sep2021 05:00, outcome "recovering", described as "Loss of appetite"; FATIGUE (non-serious) with onset 14Sep2021 05:00, outcome "recovering", described as "tiredness"; PAIN IN EXTREMITY (non-serious) with onset 14Sep2021 05:00, outcome "recovering", described as "sore arm"; HEADACHE (non-serious) with onset 14Sep2021 05:00, outcome "recovering", described as "headache". Therapeutic measures were not taken as a result of decreased appetite, fatigue, pain in extremity, headache.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has 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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test
Clinical narrative: Continued dizzyness and lightheaded ness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Sep2021 15:00 (Lot number: FE3592) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mild asthma" (unspecified if ongoing); "total hysterectomy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "allergy", notes: known_allergies: Aspirin. Vaccination history included: Bnt162b2 (dose 1, lot number= FC3181, vaccine location= Right arm), administration date: 10Aug2021, when the patient was 42 years old, for COVID-19 immunisation. The following information was reported: DIZZINESS (non-serious) with onset 10Sep2021 03:00, outcome "not recovered", described as "Continued dizzyness and lightheaded ness". The event "continued dizzyness and lightheaded ness" 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 dizziness.  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 the vaccination, the patient has been tested for COVID-19. The patient experienced continued dizzyness and lightheadedness. On top of the normal vaccine side effects.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Undiluted vials reaching 56 degrees Fahrenheit; Patient administration today; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) 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: PRODUCT STORAGE ERROR (non-serious), outcome "unknown", described as "Undiluted vials reaching 56 degrees Fahrenheit"; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 14Sep2021, outcome "unknown", described as "Patient administration today". Additional information: The reporter indicted power outage for 3 hours and 30 minutes in refrigerator,  Undiluted vials reaching 56 degrees Fahrenheit.  The reporter was asking for stability information.  The patient administration on the day of reporting. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Emotional disorder, Fatigue, Heart rate, Heart rate increased, Peripheral swelling
Clinical narrative: under a lot of stress; tired; rapid heartrate; her own arm looks like a monster; Upset; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 10Sep2021 (Lot number: FC3183) 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: STRESS (non-serious) with onset Sep2021, outcome "unknown", described as "under a lot of stress"; FATIGUE (non-serious) with onset Sep2021, outcome "unknown", described as "tired"; HEART RATE INCREASED (non-serious) with onset Sep2021, outcome "unknown", described as "rapid heartrate"; PERIPHERAL SWELLING (non-serious) with onset Sep2021, outcome "unknown", described as "her own arm looks like a monster"; EMOTIONAL DISORDER (non-serious) with onset Sep2021, outcome "unknown", described as "Upset". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient states she was upset and her own arm looks like a monster. She was under a lot of stress right now. She feels the same way, tired and a rapid heartrate.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Stress
Clinical narrative: under a lot of stress; tired; rapid heartrate; her own arm looks like a monster; Upset; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 10Sep2021 (Lot number: FC3183) 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: STRESS (non-serious) with onset Sep2021, outcome "unknown", described as "under a lot of stress"; FATIGUE (non-serious) with onset Sep2021, outcome "unknown", described as "tired"; HEART RATE INCREASED (non-serious) with onset Sep2021, outcome "unknown", described as "rapid heartrate"; PERIPHERAL SWELLING (non-serious) with onset Sep2021, outcome "unknown", described as "her own arm looks like a monster"; EMOTIONAL DISORDER (non-serious) with onset Sep2021, outcome "unknown", described as "Upset". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient states she was upset and her own arm looks like a monster. She was under a lot of stress right now. She feels the same way, tired and a rapid heartrate.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Pruritus, Rash, Rash pruritic
Clinical narrative: Received booster 1/13/2021 Itch started 1/21/2019 Over Christmas and New Years the rash was severe and extremely itchy unlike anything I have ever experienced. Prescribed hydroxizine at night and Allegra 2xs during the day. At first, this did very little for me. We are just in the medication slightly, but dermatographia continued to come out. I am still dealing with it today, although it has improved. It comes out randomly all over my body still but breakouts are less severe. It?s very unsettling not knowing when/if this will stop. I would appreciate better information on this reaction, how long it could potentially go on for, and if anyone?s dermatographia has cleared up since taking the booster shot.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vertigo
Clinical narrative: vertigo; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: I have had the COVID. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose: 1), for covid-19 Immunization. The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "vertigo". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had both shots but after patient took second shot patient got the vertigo. Consumer stated, had the COVID and had both shots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Malaise
Clinical narrative: don't feel good with upset stomachs all the time; don't feel good with upset stomachs all the time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Apr2021 (Batch/Lot number: unknown) at the age of 16 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: MALAISE (non-serious), ABDOMINAL DISCOMFORT (non-serious) all with onset 30Jun2021, outcome "not recovered" and all described as "don't feel good with upset stomachs all the time". The event "don't feel good with upset stomachs all the time" and "don't feel good with upset stomachs all the time" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of malaise, abdominal discomfort.  Additional information: No known allergies.  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 nor tested for COVID-19 since the vaccination.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202101206897 same reporter/drug/event, different patient
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal pain, Headache, Lymph node pain, Lymphadenopathy, Malaise
Clinical narrative: noticeable swelling of lymph nodes in front of neck and slight pain; noticeable swelling of lymph nodes in front of neck and slight pain; light headache; neck pain at occipital lymph nodes on left side; general malaise; cramping of gastro tract; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Sep2021 13:00 (Lot number: FC3183) at the age of 63 years as dose 1, single for covid-19 immunization.   Relevant medical history included: "CKD stage 3" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY; ZINC; VITAMIN-C; VITAMINE D; ASPIRIN LOW. Past drug history included: Codeine, notes: pennicillin & codeine; Penicillin.  The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 07Sep2021 19:00, outcome "not recovered" and all described as "noticeable swelling of lymph nodes in front of neck and slight pain"; HEADACHE (non-serious) with onset 07Sep2021 19:00, outcome "not recovered", described as "light headache"; NECK PAIN (non-serious) with onset 07Sep2021 19:00, outcome "not recovered", described as "neck pain at occipital lymph nodes on left side"; MALAISE (non-serious) with onset 07Sep2021 19:00, outcome "not recovered", described as "general malaise"; GASTROINTESTINAL PAIN (non-serious) with onset 07Sep2021 19:00, outcome "not recovered", described as "cramping of gastro tract".  Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain, headache, neck pain, malaise, gastrointestinal pain.  Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The device date was 14Sep2021. On the night of vaccination the patient had noticeable swelling of lymph nodes in front of neck and slight pain, followed that night by light headache starting with day 4 through day 7 neck pain at occipital lymph nodes on left side, pain 6 or 7 out of 10 and could not turn neck or move neck in any direction without pain, general malaise and cramping of gastro tract.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain assessment
Clinical narrative: noticeable swelling of lymph nodes in front of neck and slight pain; noticeable swelling of lymph nodes in front of neck and slight pain; light headache; neck pain at occipital lymph nodes on left side; general malaise; cramping of gastro tract; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Sep2021 13:00 (Lot number: FC3183) at the age of 63 years as dose 1, single for covid-19 immunization.   Relevant medical history included: "CKD stage 3" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY; ZINC; VITAMIN-C; VITAMINE D; ASPIRIN LOW. Past drug history included: Codeine, notes: pennicillin & codeine; Penicillin.  The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 07Sep2021 19:00, outcome "not recovered" and all described as "noticeable swelling of lymph nodes in front of neck and slight pain"; HEADACHE (non-serious) with onset 07Sep2021 19:00, outcome "not recovered", described as "light headache"; NECK PAIN (non-serious) with onset 07Sep2021 19:00, outcome "not recovered", described as "neck pain at occipital lymph nodes on left side"; MALAISE (non-serious) with onset 07Sep2021 19:00, outcome "not recovered", described as "general malaise"; GASTROINTESTINAL PAIN (non-serious) with onset 07Sep2021 19:00, outcome "not recovered", described as "cramping of gastro tract".  Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain, headache, neck pain, malaise, gastrointestinal pain.  Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The device date was 14Sep2021. On the night of vaccination the patient had noticeable swelling of lymph nodes in front of neck and slight pain, followed that night by light headache starting with day 4 through day 7 neck pain at occipital lymph nodes on left side, pain 6 or 7 out of 10 and could not turn neck or move neck in any direction without pain, general malaise and cramping of gastro tract.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "tired". Additional information: Caller stated he was a Pfizer colleague, and that when anyone told him an adverse event or potential adverse event he had reported it, stated he did this a handful of times because someone had told him something in conversation or passing, states he got a letter in the mail asking for additional information for a report, states he was unsure which reported event the letters are referring to, stated he got 2 of these letters, stated they do not state what the events were regarding. Reporter stated he thought maybe these letters are in reference to his most recently filed report on 22Aug2021. He further stated he was talking to a friend he plays video games with online, states he does not know him in real life, states the friend stated he and his wife got the Pfizer Covid vaccine and they had a sore arm after and they were tired, but the friend stated he was glad they got the vaccines. Caller stated he does not know any further information. 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-202101206829 same reporter/drug/event, different patient.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine headaches; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Aug2021 17:45 (Lot number: FC3181) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hidradenitis suppurativa" (unspecified if ongoing), notes: Hidradenitis suppurativa; "PCOS" (unspecified if ongoing), notes: PCOS; "known allergies  Penicillin" (unspecified if ongoing), notes: known allergies  Penicillin. Concomitant medication(s) included: RIFAMPIN; CLINDAMYCIN; SPIRONOLACTONE. Past drug history included: Bactrim for Drug allergy. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, Lot number=FA7484, lot unknown=False, administration date=26Jul2021, administration time=05:45 PM, dose number=1, vaccine location=Left arm), administration date: 26Jul2021, when the patient was 35 years old, for COVID-19 immunization. The following information was reported: MIGRAINE (non-serious) with onset 20Aug2021, outcome "not recovered", described as "Migraine headaches". The event "migraine headaches" was evaluated at the emergency room visit. Therapeutic measures were not taken as a result of migraine.  Additional information: No other vaccine in four weeks. The patient started receiving continual Migraine headaches on the left side of her head. This had been going on a week after the last shot, and it had been continuing on a everyday bases. She had to go to the emergency to check her head and make sure nothing was wrong with her. She had a migraine as she typed this to you, so it had been going on for a month now. No covid prior vaccination. The patient had not tested covid post vaccination.   No follow-up attempts are possible. No further information is expected. Follow-up attempts are completed.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had pain in extremity (sore arm) and fatigue (tired), with outcome of unknown. The batch/lot number not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected. Sender's comments: Linked report: US-PFIZER INC-202101206787 same reporter/drug/event, different patient.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Malaise
Clinical narrative: don't feel good with upset stomachs all the time; don't feel good with upset stomachs all the time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Apr2021 (Batch/Lot number: unknown) at the age of 12 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: MALAISE (non-serious), ABDOMINAL DISCOMFORT (non-serious) all with onset 30Jun2021, outcome "not recovered" and all described as "don't feel good with upset stomachs all the time". The event "don't feel good with upset stomachs all the time" and "don't feel good with upset stomachs all the time" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of malaise, abdominal discomfort.  Additional information: Lot number was reported as EWO180/ EW0164. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No prolonged hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any treatment for the event.  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) : PFIZER INC-202101206589 same reporter/drug/event, different patient
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Gout, Reading disorder
Clinical narrative: Gout on left toe, hard to read and reaction; Gout on left toe, hard to read and reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2020US275133.  A 80 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 80 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: GOUT (non-serious), READING DISORDER (non-serious), outcome "unknown" and all described as "Gout on left toe, hard to read and reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (parent). Other case identifier: US-PFIZER INC-202101207304 (same reporter, same vaccine, same AE, different patient). A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient (reporter's daughter) experienced nausea and illness (outcome unknown). Additional information: The reporter stated she did not get sick, or have nausea or anything after her first dose, but her daughter did. Her daughter's dose number not reported. No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Nausea
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. Other case identifier: US-PFIZER INC-202101207303 (same reporter, same vaccine, same AE, different patient). A male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had nausea and illness (my daughter and son-in-law did), with outcome of unknown. Follow-up attempts completed. No further information expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US179395_NS.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 10Aug2021 (Batch/Lot number: unknown) at the age of 63 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: CHILLS (non-serious), outcome "unknown", described as "chills".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (patient). A 43-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 43, in right arm right, on Mar 25, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced somnolence (sleepiness), onset 2021, with outcome of recovered (2021). Additional information: He took the first dose and experienced sleepiness. The next day he was fine. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: This is a spontaneous report received from contactable other HCP/consumer or other non-HCP. A 46-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 46, single dose, for COVID-19 immunisation. The patient's relevant medical history not reported. Concomitant medication included Xeljanz XR, start date: Sep 1, 2020. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), single dose, for COVID-19 immunisation. The patient experienced malaise (the 2nd dose of COVID-19 vaccine made her feel terrible), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood cholesterol, Blood pressure measurement, C-reactive protein, Full blood count
Clinical narrative: headaches; tenderness in left arm; weakness; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (141003).  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 09Sep2021 (Batch/Lot number: unknown) at the age of 63 years as dose 3, single for covid-19 immunisation. Relevant medical history included: "anemia" (ongoing), notes: she has anemia before it was bad and now improved.; "fall", start date: 2021 (unspecified if ongoing), notes: had a fall 2 months ago, still have bruises now; "bruises", start date: 2021 (ongoing), notes: had a fall 2 months ago, still have bruises now; "hematoma/small blood clot" (not ongoing), notes: she had hematoma/small blood clot in the dented area of right lower leg (right leg is her bad leg) as a result of injury from the fall, this has resolved, md aware; "hematoma/small blood clot" (not ongoing), notes: she had hematoma/small blood clot in the dented area of right lower leg (right leg is her bad leg) as a result of injury from the fall, this has resolved, md aware; "Rheumatoid Arthritis" (ongoing), notes: Diagnosis or Reason for Use: Rheumatoid Arthritis. The patient took concomitant medications. Vaccination history included: Bnt162b2 (First Dose), for COVID-19 immunization; Bnt162b2 (Second Dose), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 10Sep2021, outcome "recovered" (11Sep2021), described as "headaches"; TENDERNESS (non-serious) with onset 10Sep2021, outcome "recovered" (11Sep2021), described as "tenderness in left arm"; ASTHENIA (non-serious) with onset 10Sep2021, outcome "recovered" (11Sep2021), described as "weakness". Relevant laboratory tests and procedures are available in the appropriate section.  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 completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin, Headache, Metabolic function test, Tenderness, Ultrasound Doppler
Clinical narrative: headaches; tenderness in left arm; weakness; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (141003).  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 09Sep2021 (Batch/Lot number: unknown) at the age of 63 years as dose 3, single for covid-19 immunisation. Relevant medical history included: "anemia" (ongoing), notes: she has anemia before it was bad and now improved.; "fall", start date: 2021 (unspecified if ongoing), notes: had a fall 2 months ago, still have bruises now; "bruises", start date: 2021 (ongoing), notes: had a fall 2 months ago, still have bruises now; "hematoma/small blood clot" (not ongoing), notes: she had hematoma/small blood clot in the dented area of right lower leg (right leg is her bad leg) as a result of injury from the fall, this has resolved, md aware; "hematoma/small blood clot" (not ongoing), notes: she had hematoma/small blood clot in the dented area of right lower leg (right leg is her bad leg) as a result of injury from the fall, this has resolved, md aware; "Rheumatoid Arthritis" (ongoing), notes: Diagnosis or Reason for Use: Rheumatoid Arthritis. The patient took concomitant medications. Vaccination history included: Bnt162b2 (First Dose), for COVID-19 immunization; Bnt162b2 (Second Dose), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 10Sep2021, outcome "recovered" (11Sep2021), described as "headaches"; TENDERNESS (non-serious) with onset 10Sep2021, outcome "recovered" (11Sep2021), described as "tenderness in left arm"; ASTHENIA (non-serious) with onset 10Sep2021, outcome "recovered" (11Sep2021), described as "weakness". Relevant laboratory tests and procedures are available in the appropriate section.  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 completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: she "got the runs really bad and it lasted for quite a while."; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (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), for Covid-19 Immunization. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "she "got the runs really bad and it lasted for quite a while.  Additional information: Patient stated that the clinic provided transportation for her to be able to get to the clinic since the weather was very bad. She did not provide the address of this clinic nor the name/occupation of the healthcare professional that administered the 2nd dose. Patient stated that she was not at home right now and was on a semi on the road and does not remember the date of administration of 2nd dose of the Pfizer Covid-19 vaccine. She stated that after receiving the 2nd dose, she "got the runs really bad and it lasted for quite a while. She said that does not keep track of dates and so does not know the start date and how long this event lasted. She stated that she has already provided all of the information she has for this report and declined to provide her mailing address and stated she does not consent to further follow-up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: my throat is a little sore my throat hurts a little bit; I am having headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101211819 (Pfizer).  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 26Aug2021 (Lot number: EW0196) at the age of 63 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: OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "not recovered", described as "my throat is a little sore my throat hurts a little bit"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "I am having headache". The event "my throat is a little sore my throat hurts a little bit" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of oropharyngeal pain, headache.  Additional information: reporter stated, What I was trying cause I am supposed to get my second shot, Thursday, on the 16th, I was concerned cause my throat is a little sore and I am just worried about my throat being sore and I am having headache. So is this still okay to take that second shot. Scheduled Date of Second Dose: 16Sep2021. the second dose of the vaccine tomorrow. Caller reports having a sore throat off/on for 2-3 days; she suspects she scratched her throat from eating chips. Caller asked if she should receive her second dose.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0196), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had oropharyngeal pain (outcome unknown) and headache (outcome unknown). Additional information: Patient wanted to talk to a nurse. Patient was supposed to have a shot (confirmed later as second shot of Pfizer COVID-19 vaccine on Sep 16, 2021). The patient's throat was kind of sore (a little bit) and having a headache off and on. The patient just wanted to know if it's okay to still take the shot or get tested for COVID-19. No follow-up attempts possible. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 09:45 (Lot number: EW0187) at the age of 44 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Endometriosis" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. There were no concomitant medications. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Very Stiff neck"; HEADACHE (non-serious) with onset 27Aug2021 10:15, outcome "not recovered", described as "headache"; LYMPHADENOPATHY (non-serious) with onset 27Aug2021 10:15, outcome "not recovered", described as "swollen lymph nodes". Therapeutic measures were not taken as a result of musculoskeletal stiffness, headache, lymphadenopathy. Additional information: On 27Aug2021 10:15 the patient had very stiff neck (within 15 mins) of first shot with headache and swollen lymph nodes. The patient had still have all 3 adverse events bothering her. The patient had to decided to postpone the 2nd shot just in case. The patient did not receive any other vaccine within 4 weeks. The patient did not have any other medications the patient received within 2 weeks of vaccination. The event was non serious and did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Biopsy, Lymphadenopathy, Magnetic resonance imaging
Clinical narrative: my lymph node was swollen in my neck and have since found after an MRI they are all swollen; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2021 (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: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "my lymph node was swollen in my neck and have since found after an MRI they are all swollen". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow up (15Sep2021): This a follow up spontaneous report from a contactable consumer.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  Follow-up (25Oct2021): 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 completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Discomfort, Exposure during pregnancy, Fibrin D dimer, Lymphadenopathy
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 39 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Jan2021 08:00 (Batch/Lot number: unknown) at the age of 39 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "was diagnosed with Covid-19", start date: 26Dec2020 (unspecified if ongoing), notes: who was diagnosed with Covid-19 on 26Dec2020; "her symptom included an ear ache" (unspecified if ongoing), notes: her symptom included an ear ache. There were no concomitant medications. The following information was reported: EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "pregnancy"; LYMPHADENOPATHY (non-serious) with onset 03Feb2021, outcome "unknown", described as "lymph node swelling in right lower quadrant"; NAUSEA (non-serious), outcome "unknown", described as "kind of nauseated"; DISCOMFORT (non-serious), outcome "unknown", described as "had was uncomfortable in the right lower quadrant". The events "pregnancy", "lymph node swelling in right lower quadrant", "kind of nauseated" and "had was uncomfortable in the right lower quadrant" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Patient stated that on 04Jan2021 her husband was diagnosed with Covid-91 as well. On 30Jan2021 8am, she received her first dose of the Pfizer Covid-19 vaccine and had complaints of RLQ lymph nodes and pregnancy, and gallstones were ruled out. The caller would like to provide background first, caller tested positive for Covid on 28Jan2021 and was scheduled for first dose on 30Jan2021. The patient called Pfizer and the recommended time was 21 days after Covid positive, but said the patient was okay to receive the first dose Pfizer Covid Vaccine. Caller states the recommendations have since changed to 90 days to receive Pfizer Covid Vaccine after testing positive for Covid. The lot number for bnt162b2 was not provided and will be requested during follow up. Follow-up (15Sep2021): This is a follow-up spontaneous report from a Pfizer-sponsored program. Follow-up attempts are completed. No further information is expected. Follow-up (27Sep2021): This is a follow-up report from a contactable pharmacist communicated to a Pfizer colleague regarding BNT162B2. Follow-up attempts are completed. No further information is expected
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Physical examination, SARS-CoV-2 test, Ultrasound Doppler
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 39 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Jan2021 08:00 (Batch/Lot number: unknown) at the age of 39 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "was diagnosed with Covid-19", start date: 26Dec2020 (unspecified if ongoing), notes: who was diagnosed with Covid-19 on 26Dec2020; "her symptom included an ear ache" (unspecified if ongoing), notes: her symptom included an ear ache. There were no concomitant medications. The following information was reported: EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "pregnancy"; LYMPHADENOPATHY (non-serious) with onset 03Feb2021, outcome "unknown", described as "lymph node swelling in right lower quadrant"; NAUSEA (non-serious), outcome "unknown", described as "kind of nauseated"; DISCOMFORT (non-serious), outcome "unknown", described as "had was uncomfortable in the right lower quadrant". The events "pregnancy", "lymph node swelling in right lower quadrant", "kind of nauseated" and "had was uncomfortable in the right lower quadrant" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Patient stated that on 04Jan2021 her husband was diagnosed with Covid-91 as well. On 30Jan2021 8am, she received her first dose of the Pfizer Covid-19 vaccine and had complaints of RLQ lymph nodes and pregnancy, and gallstones were ruled out. The caller would like to provide background first, caller tested positive for Covid on 28Jan2021 and was scheduled for first dose on 30Jan2021. The patient called Pfizer and the recommended time was 21 days after Covid positive, but said the patient was okay to receive the first dose Pfizer Covid Vaccine. Caller states the recommendations have since changed to 90 days to receive Pfizer Covid Vaccine after testing positive for Covid. The lot number for bnt162b2 was not provided and will be requested during follow up. Follow-up (15Sep2021): This is a follow-up spontaneous report from a Pfizer-sponsored program. Follow-up attempts are completed. No further information is expected. Follow-up (27Sep2021): This is a follow-up report from a contactable pharmacist communicated to a Pfizer colleague regarding BNT162B2. Follow-up attempts are completed. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood testosterone, Fatigue, Illness, Somnolence
Clinical narrative: fatigue; weakness; grogginess; I feel drained and sick; 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. Other Case identifier(s): US-PFIZER INC-202101212191.  A male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (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), administration date: 2021, for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "fatigue"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "weakness"; SOMNOLENCE (non-serious) with onset 2021, outcome "not recovered", described as "grogginess"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "I feel drained and sick". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: Caller, reporting on the Covid vaccine and who explains that he got both shots in either February and March or in March and April. Since then he has a lot of fatigue. Caller mentions he cant test for Covid because the symptoms are more than a few days old, this seems to have been going on was since the vaccine. He is wondering if the weakness and grogginess he is feeling could be long term side effects to the vaccine. Caller declines the report explaining that he cant be accurate on the events and when they started but it feels like this has been going on since getting the vaccine; he doesn't have exact dates and doesn't know when he was faced with this exactly. He feels like he has a virus without the respiratory symptoms but he is not sure he can make absolutely certain this is attributed to the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.