chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: lightheadedness; feeling drained/Fatigue; This is a spontaneous report received from a 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, administration date 18Nov2021 18:00 (Lot number: 30155BA) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Repeating Node Relevant past drug history: , Name of Drug as Reported: no, Reaction: Allergy , . Concomitant medication(s) included: FLU taken for immunisation. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: 3248, Location of injection: Arm Left, Vaccine Administration Time: 13:00 PM), administration date: 23Mar2021, when the patient was 39 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Left, Vaccine Administration Time: 13:00 PM), administration date: 02Mar2021, when the patient was 39 years old, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 19Nov2021 06:00, outcome "not recovered", described as "lightheadedness"; FATIGUE (non-serious) with onset 19Nov2021 06:00, outcome "not recovered", described as "feeling drained/Fatigue". Therapeutic measures were not taken as a result of dizziness, fatigue.  Additional information: Other medications the patient received within 2 weeks of vaccination included Flu Shot Quad. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. No treatment was received.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness the day after the injection was given; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness the day after the injection was given".  Additional information: It was reported that patient received COVID vaccine for 5- to 11-year-old and experience above event. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, SARS-CoV-2 antibody test, SARS-CoV-2 test, Taste disorder
Clinical narrative: sense of smell and taste were impacted.; sense of smell and taste were impacted.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Nov2021 15:30 (Lot number: FF2587) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ELURYNG. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6205, Location of injection: Arm Left), administration date: 07Mar2021, when the patient was 34 years old, for COVID-19 Immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL 9267, Location of injection: Arm Left), administration date: 14Feb2021, when the patient was 34 years old, for COVID-19 Immunisation. The following information was reported: TASTE DISORDER (non-serious), PAROSMIA (non-serious) all with onset 16Nov2021, outcome "recovered" and all described as "sense of smell and taste were impacted.". The event "sense of smell and taste were impacted." and "sense of smell and taste were impacted." 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 taste disorder, parosmia.  Additional Information: My sense of smell and taste were impacted. For example, sense of smell became heightened in some cases, muted in others, and distorted. My own scent (at least to myself) became oniony for several days after the vaccine - and I developed a metallic and off putting taste when eating things I'd usually enjoy like ice cream. One week after the fact I can eat from the same carton of ice cream and it tastes fine again. No covid prior vaccination. Tested covid post vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Illness anxiety disorder
Clinical narrative: getting sick; hypochondriac; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). 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: ILLNESS (non-serious), outcome "unknown", described as "getting sick"; ILLNESS ANXIETY DISORDER (non-serious), outcome "unknown", described as "hypochondriac".  Additional information: Adverse event: Listening to Podcast. One of the hosts said has had a cold/ allergy for two weeks, that they were unsure which one. They did not have a sore throat or fever and sneezed at least once on the show. The other host is a hypochondriac and thought were getting sick. Likely both individuals are vaccinated. The show released 24Jun2021. Individual has gone through approximately 75 tissues in 37 mins of episode. Approximately one full 65 tissues tissue box plus around 10 more tissues. Had listened to podcast yesterday but did not hear this.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Nausea; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 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: NAUSEA (non-serious), outcome "unknown", described as "Nausea"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea".  Additional information: A husband called for his wife, Patient got the Covid vaccine and explained that got the shot on Wednesday and has had nausea and diarrhea and he was wondering what over the counter product she can take for this.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: lymph nodes under my left arm were swollen for 2 days; occasional pain in the lymph nodes; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Nov2021 09:30 (Lot number: EWO173) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient received concomitant medication(s) LOSARTAN + HIDROCLOROTIAZIDA within 2 weeks of vaccination. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8734, Location of injection: Left Arm , Vaccine Administration Time: 03:15 PM), administration date: 27Mar2021, when the patient was 58 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6200, Location of injection: Left Arm , Vaccine Administration Time: 03:15 PM), administration date: 06Mar2021, when the patient was 58 years old, for COVID-19 Immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In other facility where the most recent COVID-19 vaccine was administered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The following information was reported: LYMPHADENOPATHY (non-serious) with onset 16Nov2021, outcome "recovered" (18Nov2021), described as "lymph nodes under my left arm were swollen for 2 days"; LYMPH NODE PAIN (non-serious) with onset 16Nov2021, outcome "recovered" (Nov2021), described as "occasional pain in the lymph nodes". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain.  Additional information: Reaction/event as reported by primary source: 2 days after the 3rd vaccination the lymph nodes under my left arm were swollen for 2 days. There was occasional pain in the lymph nodes. It has since resolved and there is no pain in the injection site or in the lymph nodes.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: UNK
Symptoms: Drug interaction
Clinical narrative: Drug interactions with the COVID Shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a sponsored program (002191). The reporter is the patient.  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: DRUG INTERACTION (non-serious), outcome "unknown", described as "Drug interactions with the COVID Shot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Decreased appetite, Fatigue, Fluid intake reduced, Malaise, Oropharyngeal pain
Clinical narrative: Has a little sore throat; He is not drinking anything; not eating anything; He gets up and plays a little but he gets real tired; He doesn''t feel good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Lot number: FK5127) as dose number unknown, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Has a little sore throat"; FLUID INTAKE REDUCED (non-serious), outcome "unknown", described as "He is not drinking anything"; DECREASED APPETITE (non-serious), outcome "unknown", described as "not eating anything"; FATIGUE (non-serious), outcome "unknown", described as "He gets up and plays a little but he gets real tired"; MALAISE (non-serious), outcome "unknown", described as "He doesn''t feel good".  Additional information: NDC number, expiry date and UPC number were reported as unknown. The patient got the Covid virus shot on Wednesday, wanted to see how long it lasts. He had a little sore throat, he was not drinking anything and not eating anything since he got up today. He did told that 10 o'clock last night, the Covid shot was given Wednesday. He gets up and plays a little, but he gets real tired. Wanted to know if getting him the flu shot (unspecified flu shot) and the covid shot at the same time was going to affect him worse. Unknown if patient took flu shot and covid shot at the same time. He doesn't feel good.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: a feeling of being queasy; headache; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single and (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: NAUSEA (non-serious), outcome "unknown", described as "a feeling of being queasy"; HEADACHE (non-serious), outcome "unknown", described as "headache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: The patient was thinking of getting Moderna booster dose.  No follow-up attempts are possible; information about lot/batch number not available despite the follow-up attempts made. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 8 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 17:15 (Lot number: FK5127) 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: VACCINATION SITE PAIN (non-serious) with onset 19Nov2021, outcome "recovering", described as "Soreness at injection site".  Additional information: of soreness at injection site; started yesterday and continuing today but reportedly a lot better today  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: losing her hair; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient in her 40's 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: ALOPECIA (non-serious), outcome "unknown", described as "losing her hair".  Additional information: it was reported that, event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness, fatigue after shot; 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 21Nov2021 (Batch/Lot number: unknown) as dose number unknown, 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: FATIGUE (non-serious) with onset Nov2021, outcome "unknown", described as "Tiredness, fatigue after shot".  Additional information: NDC number was not provided. Investigation assessment was not reported.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 (Lot number: BP7534) at the age of 50 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: FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "Tiredness". The event "tiredness" was evaluated at the physician office visit.  Additional Information: Patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021, 16:00 (Lot number: unknown) as dose 2, single for covid-19 immunisation. Reaction reported was Extreme weight loss with onset Apr2021, Burning tongue, Nausea with outcome not recovered. Reporter states that the Caller was calling on behalf of his sister who got the second dose of the Pfizer Covid 19 vaccine, two months ago. The Caller provided his sister's age as 52, but later in Call, her age is confirmed as 50. Caller reports his sister had extreme weight loss, burning tongue, tiredness, and nausea. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks) no other vaccinations within four weeks prior to the first administration date of the suspect vaccine.Caller stated that his "sister took the vaccine maybe 2 months ago (second dose), maybe 3-4 months ago, no actually 4 months ago". Pfizer Covid-19 vaccine (adult formulation) confirmed. Caller said that they've "notice significant changes like extreme weight loss, burning tongue. several, different, tired all kind of crazy stuffs that we think are related."  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Headache; Not feeling well for a day; 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 Mar2021 (Batch/Lot number: unknown) as dose 1, single and administration date Mar2021 (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: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "Not feeling well for a day".  Additional information: Patient had was, just headache like mild.  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: M
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: 1st dose on 27Apr2021/2nd dose on 14May2021; After his 2nd dose, he never became well and continued to be ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65 year-old male patient received bnt162b2 (COMIRNATY), administration date 14May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "HTN" (unspecified if ongoing); "CLL (Chronic lymphocytic leukemia)" (unspecified if ongoing), notes: He is not taking any medication for his CLL (no immunosuppressants); "COVID" (unspecified if ongoing), notes: Before he got his 2nd dose, he got in contact with someone with COVID. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: 27Apr2021, when the patient was 65 years old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 14May2021, outcome "unknown", described as "1st dose on 27Apr2021/2nd dose on 14May2021"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "After his 2nd dose, he never became well and continued to be ill". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed. No further information is expected. The lot/batch number is not available despite the follow-up attempts made.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Neutrophil count increased
Clinical narrative: elevated blood sugar; very high neutrophils; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 5 year-old male patient received bnt162b2 (BNT162B2), administration date 13Nov2021 (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: BLOOD GLUCOSE INCREASED (non-serious) with onset 19Nov2021, outcome "unknown", described as "elevated blood sugar"; NEUTROPHIL COUNT INCREASED (non-serious) with onset 19Nov2021, outcome "unknown", described as "very high neutrophils". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient age is 5 and half year old Consumer wants to know if this has been reported in the clinical trials for children and adults after receiving the 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: Investigation, Loss of personal independence in daily activities, Migraine, SARS-CoV-2 test
Clinical narrative: migraines; I have not been able to work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (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 "not recovered", described as "migraines"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "not recovered", described as "I have not been able to work". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that she received both doses of Comirnaty but did not specify a timeframe and was having migraines every day for the past 7 weeks, she had not been able to work because of them. All her tests and labs came back negative and was tested for Covid six times, she don't have Covid.  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, FLUX
Symptoms: Fatigue, Off label use, Pain, Product use issue, Vaccination site pain
Clinical narrative: Soreness at injection site; Body aches; General fatigue; Most recent dose details product=COVID 19, other vaccine same date product=Influenza Quad Valent; Most recent dose details product=COVID 19, other vaccine same date product=Influenza Quad Valent; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 01Dec2021 11:30 (Lot number: FH8030) at the age of 48 years as dose 1, single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administered in arm right, administration date 01Dec2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. Relevant medical history included: "Insomnia" (unspecified if ongoing). Concomitant medication(s) included: LUNESTA; IBUPROFEN; TRUVADA. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 01Dec2021, outcome "unknown" and all described as "Most recent dose details product=COVID 19, other vaccine same date product=Influenza Quad Valent"; VACCINATION SITE PAIN (non-serious) with onset 01Dec2021 19:00, outcome "not recovered", described as "Soreness at injection site"; PAIN (non-serious) with onset 01Dec2021 19:00, outcome "not recovered", described as "Body aches"; FATIGUE (non-serious) with onset 01Dec2021 19:00, outcome "not recovered", described as "General fatigue". The action taken for influenza vaccine was unknown. Therapeutic measures were taken as a result of vaccination site pain, pain, fatigue.  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of vaccination site pain, pain and fatigue which included treatment with ADVIL. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jul2021 (Lot number: EW0181) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "PTSD" (unspecified if ongoing), notes: PTSD; "Thyroid" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Muscle Relaxer" (unspecified if ongoing), notes: Muscle Relaxer. Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder, start date: 2021 (ongoing); PAXIL [PIROXICAM] taken for post-traumatic stress disorder (ongoing); ROSUVASTATIN taken for blood cholesterol, start date: 2021 (ongoing); METFORMIN taken for diabetes mellitus, start date: 2021 (ongoing); ALPRAZOLAM taken for anxiety, post-traumatic stress disorder, depression, start date: 2014 (ongoing); TRIAZINE taken for hypotonia (ongoing); VITAMIN D3, start date: 2021 (ongoing).  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm pain". Therapeutic measures were taken as a result of pain in extremity.  Additional information: Patient also takes Tylenol for pain every day.   No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Feeling of vertigo when standing up/sitting down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Oct2021 11:30 (Lot number: 30145BA) at the age of 41 years as dose 1, single and administered in arm left, administration date 13Nov2021 13:00 (Lot number: 3013058A) 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: VERTIGO (non-serious) with onset 08Oct2021 12:00, outcome "not recovered", described as "Feeling of vertigo when standing up/sitting down". Therapeutic measures were not taken as a result of vertigo.  Additional information: It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19 and Since the vaccination has not been tested for COVID-19. No known allergies. Serious: No.   Follow-up attempts are completed. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: hands are swollen and painful; hands are swollen and painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 84 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 84 years as dose number unknown, (booster) single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious), outcome "unknown" and all described as "hands are swollen and painful".  Additional Information: The report did not related to a study or programme. She got the Pfizer Covid booster shot and the caller states that her hands are swollen and painful.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Laboratory test
Clinical narrative: tired; 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 21Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "I had always have low blood pressure my whole life" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN B [VITAMIN B COMPLEX]. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "recovering", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Had the first vaccine and did okay I was tired but I did okay and finally after 2 weeks I started feeling better. Consumer stated, I take B vitamin (further not clarified) and just the other thing I wanted to tell you. I had always have low blood pressure my whole life (further not clarified). Just after the vaccine I went to see my doctor to get the regular checkup, my blood pressure was (incomplete sentence), and she put me on a very low dose of blood pressure medication (Not clarified) for the first time in my life. So, you know this is not going to work for me, I can't live like this. I mean I am not going to, I don't do, when I say I can't live like this. I mean I am not going to get another vaccine unless totally improved they offer me, just to help me a little. Patient did not receive any other vaccine previously.   Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101721403 similar report from same reporter;US-PFIZER INC-202101721495 similar report from same reporter
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product preparation issue, Underdose
Clinical narrative: they received were overdiluted/The vaccines were diluted with 2.0 mls of diluent instead of 1.8 mls; they received were overdiluted/The vaccines were diluted with 2.0 mls of diluent instead of 1.8 mls; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 16Apr2021 (Lot number: EW0162) as dose 1, single and administration date 07May2021 (Lot number: EW0171) as dose 2, single for covid-19 immunisation. Relevant medical history included: "lung issues" (unspecified if ongoing), notes: Verbatim: lung issues; "used to smoke" (unspecified if ongoing), notes: Additional Information for Other Conditions: used to smoke, gets pneumonia and bronchitis.; "pneumonia" (unspecified if ongoing), notes: Additional Information for Other Conditions: used to smoke, gets pneumonia and bronchitis.; "bronchitis" (unspecified if ongoing), notes: Additional Information for Other Conditions: used to smoke, gets pneumonia and bronchitis. There were no concomitant medications. The following information was reported: UNDERDOSE (non-serious), PRODUCT PREPARATION ISSUE (non-serious) all with onset 2021, outcome "unknown" and all described as "they received were overdiluted/The vaccines were diluted with 2.0 mls of diluent instead of 1.8 mls"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm".  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: On the left side of forehead, keep getting a pins and needles feeling.; This is a spontaneous report received from a contactable reporter (consumer or other non HCP). The reporter is the patient.   A 35-year-old male patient received bnt162b2 (BNT162b2), administered in right arm, administration date 29Sep2021 at 14:30 (Lot number: EW0151) at the age of 35 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Superficial punctate keratitis" (unspecified if ongoing), notes: Thygeson and "Milk allergy" (unspecified if ongoing), notes: Known allergies: Milk. Concomitant medications included unspecified pre workout HTLT.  The following information was reported: PARAESTHESIA (non-serious) with onset 05Oct2021 at 16:30, outcome "not recovered", described as "On the left side of forehead, keep getting a pins and needles feeling". The event "On the left side of forehead, keep getting a pins and needles feeling." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of paraesthesia.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. It was reported that pins and needles feeling lasted about 3-5 seconds and could happen from a couple times an hour to nothing for hours and it just happened randomly.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: Getting reaction headache from the second shot; It is like I have Migraine; 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 Nov2021 (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: Covid-19 vaccine (Dose 1; manufacturer unknown), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset Nov2021, outcome "not recovered", described as "Getting reaction headache from the second shot"; MIGRAINE (non-serious) with onset Nov2021, outcome "not recovered", described as "It is like I have Migraine".   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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Device issue, Headache, Inappropriate schedule of product administration, Incorrect dose administered
Clinical narrative: Injection site papule; Chills; Flu like symptoms; Headache; Lethargy; Injection site pain; Device issue; Inappropriate dose of drug administered; On 22May2021, patient received 1st dose COVID-19 Vaccine/On 08Jun2021, patient received 2nd dose COVID-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4182651-00 (regulatory authority).  A 36 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 08Jun2021 (Lot number: EW0178) at the age of 36 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous since 18Mar2021 (ongoing) (Batch/Lot number: unknown) at 40 mg for hidradenitis. Relevant medical history included: "Trigeminal neuralgia" (unspecified if ongoing); "severe itching" (unspecified if ongoing); "impaired vision" (unspecified if ongoing). Concomitant medication(s) included: DIAMOX SANKEN [ACETAZOLAMIDE]; TOPAMAX MIGRAENE taken for trigeminal neuralgia; GABAPENTIN taken for trigeminal neuralgia; TEGRETOL CR taken for trigeminal neuralgia; FOLIC ACID ALMUS; METRONIDAZOLE; JUNEL FE taken for contraception; LAMICTAL taken for trigeminal neuralgia. Past drug history included: Dilaudid, reaction(s): "Known allergy:Dilaudid"; Tetracyclines, reaction(s): "Known allergy: Tetracycline". Vaccination history included: Bnt162b2 (Dose:1, single, Lot number: EW0178.), administration date: 22May2021, when the patient was 36 years old, for COVID-19 Immunization.The following information was reported: INJECTION SITE PAPULE (non-serious) with onset 30Nov2021, outcome "recovering", described as "Injection site papule"; INJECTION SITE PAIN (non-serious) with onset 18Mar2021, outcome "recovered" (30Nov2021), described as "Injection site pain"; INFLUENZA LIKE ILLNESS (non-serious) with onset Jun2021, outcome "recovered" (Jun2021), described as "Flu like symptoms"; HEADACHE (non-serious) with onset Jun2021, outcome "recovered" (Jun2021), described as "Headache"; LETHARGY (non-serious) with onset Jun2021, outcome "recovered" (Jun2021), described as "Lethargy"; DEVICE ISSUE (non-serious) with onset 2021, outcome "unknown", described as "Device issue"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 2021, outcome "unknown", described as "Inappropriate dose of drug administered"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 2021, outcome "unknown", described as "On 22May2021, patient received 1st dose COVID-19 Vaccine/On 08Jun2021, patient received 2nd dose COVID-19 Vaccine"; CHILLS (non-serious) with onset Jun2021, outcome "recovered" (Jun2021), described as "Chills". The action taken for adalimumab was dosage not changed. Therapeutic measures were taken as a result of injection site papule, injection site pain, influenza like illness, headache, lethargy, chills.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site pain, Injection site papule, Lethargy
Clinical narrative: Injection site papule; Chills; Flu like symptoms; Headache; Lethargy; Injection site pain; Device issue; Inappropriate dose of drug administered; On 22May2021, patient received 1st dose COVID-19 Vaccine/On 08Jun2021, patient received 2nd dose COVID-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4182651-00 (regulatory authority).  A 36 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 08Jun2021 (Lot number: EW0178) at the age of 36 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous since 18Mar2021 (ongoing) (Batch/Lot number: unknown) at 40 mg for hidradenitis. Relevant medical history included: "Trigeminal neuralgia" (unspecified if ongoing); "severe itching" (unspecified if ongoing); "impaired vision" (unspecified if ongoing). Concomitant medication(s) included: DIAMOX SANKEN [ACETAZOLAMIDE]; TOPAMAX MIGRAENE taken for trigeminal neuralgia; GABAPENTIN taken for trigeminal neuralgia; TEGRETOL CR taken for trigeminal neuralgia; FOLIC ACID ALMUS; METRONIDAZOLE; JUNEL FE taken for contraception; LAMICTAL taken for trigeminal neuralgia. Past drug history included: Dilaudid, reaction(s): "Known allergy:Dilaudid"; Tetracyclines, reaction(s): "Known allergy: Tetracycline". Vaccination history included: Bnt162b2 (Dose:1, single, Lot number: EW0178.), administration date: 22May2021, when the patient was 36 years old, for COVID-19 Immunization.The following information was reported: INJECTION SITE PAPULE (non-serious) with onset 30Nov2021, outcome "recovering", described as "Injection site papule"; INJECTION SITE PAIN (non-serious) with onset 18Mar2021, outcome "recovered" (30Nov2021), described as "Injection site pain"; INFLUENZA LIKE ILLNESS (non-serious) with onset Jun2021, outcome "recovered" (Jun2021), described as "Flu like symptoms"; HEADACHE (non-serious) with onset Jun2021, outcome "recovered" (Jun2021), described as "Headache"; LETHARGY (non-serious) with onset Jun2021, outcome "recovered" (Jun2021), described as "Lethargy"; DEVICE ISSUE (non-serious) with onset 2021, outcome "unknown", described as "Device issue"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 2021, outcome "unknown", described as "Inappropriate dose of drug administered"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 2021, outcome "unknown", described as "On 22May2021, patient received 1st dose COVID-19 Vaccine/On 08Jun2021, patient received 2nd dose COVID-19 Vaccine"; CHILLS (non-serious) with onset Jun2021, outcome "recovered" (Jun2021), described as "Chills". The action taken for adalimumab was dosage not changed. Therapeutic measures were taken as a result of injection site papule, injection site pain, influenza like illness, headache, lethargy, chills.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Ligament sprain, Nasal congestion, Nasopharyngitis
Clinical narrative: congestion; sickness; a cold that travelled through their family; headaches; Sprained/twisted their ankle believed about 6 months ago/retwisted their ankle; hurt/They said it was hurting.; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Gluten, reaction(s): "known allergies: gluten", notes: known allergies: gluten. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headaches"; LIGAMENT SPRAIN (non-serious) with onset 2021, outcome "not recovered", described as "Sprained/twisted their ankle believed about 6 months ago/retwisted their ankle"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "hurt/They said it was hurting."; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; ILLNESS (non-serious), outcome "unknown", described as "sickness"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "a cold that travelled through their family".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: congestion; sickness; a cold that travelled through their family; headaches; Sprained/twisted their ankle believed about 6 months ago/retwisted their ankle; hurt/They said it was hurting.; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Gluten, reaction(s): "known allergies: gluten", notes: known allergies: gluten. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headaches"; LIGAMENT SPRAIN (non-serious) with onset 2021, outcome "not recovered", described as "Sprained/twisted their ankle believed about 6 months ago/retwisted their ankle"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "hurt/They said it was hurting."; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; ILLNESS (non-serious), outcome "unknown", described as "sickness"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "a cold that travelled through their family".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 9 year-old male patient received bnt162b2 (BNT162B2), administration date Dec2021 (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, the first shot, there was nothing wrong, they were totally fine, nothing happened until now."), for COVID-19 immunization, reaction(s): "there was nothing wrong, they were totally fine". The following information was reported: RHINORRHOEA (non-serious) with onset 06Dec2021, outcome "not recovered", described as "Runny nose".  This is the second case out of two cases in which the reporter is reporting for her 9-year-old son. Reporter stated, "I am calling about my boys, I have a 6-year-old and a 9-year-old. It was reported I have a 9-year-old, he was totally fine nothing wrong with him until today, he woke up and now, he has the runny nose as well." When further confirmed if both patients got the second shot, reporter stated, "Yes, it was their second shot, the first shot, there was nothing wrong, they were totally fine, nothing happened until now." Is COVID-19 Vaccine a Pfizer product: Yes. COVID-19 Vaccine manufacturer: Unspecified. Number of COVID-19 Vaccine: Unknown. Reason for no lot number: of COVID-19 Vaccine: Complainant hung up abruptly/transfer incomplete. Expiry Date of COVID-19 Vaccine: Unknown.  Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart problems; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male 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: Covid-19 vaccine (1st dose), for COVID-19 immunization. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart problems". The event "heart problems" was evaluated at the physician office visit.  Additional information: It was reported that a boy who was allegedly rushed to the hospital after having heart problems, claimed to have been caused by the second Pfizer shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.