chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Gastrointestinal pain, Nausea, Oropharyngeal pain
Clinical narrative: horrible, debilitating stomach pain, the pain was actually from the top of throat down to lower stomach and felt like somebody ripped out the guts; the pain was actually from the top of throat; mostly a feeling having been punched in the gut and insides were put through a ringer; extreme nausea; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 23Mar2021 13:45 (lot number ER2613) at the age of 56-years (as reported) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Epstein barr virus" (unspecified if ongoing); "allergies: comparing, many antibiotics" (unspecified if ongoing); "thyroid" (unspecified if ongoing). Concomitant medications included: CLARITINE and, vitamins. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 2021, outcome "recovered with sequelae" (2021), described as "horrible, debilitating stomach pain, the pain was actually from the top of throat down to lower stomach and felt like somebody ripped out the guts"; OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "recovered with sequelae" (2021), described as "the pain was actually from the top of throat"; GASTROINTESTINAL PAIN (non-serious) with onset 2021, outcome "recovered with sequelae" (2021), described as "mostly a feeling having been punched in the gut and insides were put through a ringer"; NAUSEA (non-serious) with onset 2021, outcome "recovered with sequelae" (2021), described as "extreme nausea". Therapeutic measures were not taken as a result of abdominal pain upper, oropharyngeal pain, gastrointestinal pain, and nausea.  Additional Information: There was no cramping, no diarrhea, no vomiting. The patient doesn't know how else to explain this as she hasn't experienced this type of pain before. The patient didn't have covid-19 prior vaccination. The patient was not tested for covid-19 post-vaccination. No other vaccines were received prior to the covid-19 vaccine.  No follow-up attempts are possible. No further information is expected.  Follow-up (12May2021): Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: Chills; Nausea; Headache; Body aches; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 43-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm right, administration date 26Mar2021 12:20 (Lot number: ER8727) at the age of 43 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Asthma" (unspecified if ongoing); "Frequent UTIs" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Anatomical Site of injection: Arm), administration date: 05Mar2021, for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and the patient has not been tested for COVID-19 since the vaccination. The following information was reported: CHILLS (non-serious) with onset 27Mar2021, outcome "recovered", described as "Chills"; NAUSEA (non-serious) with onset 27Mar2021, outcome "recovered", described as "Nausea"; HEADACHE (non-serious) with onset 27Mar2021, outcome "recovered", described as "Headache"; PAIN (non-serious) with onset 27Mar2021, outcome "recovered", described as "Body aches". Therapeutic measures were not taken as a result of chills, nausea, headache, pain.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Night sweats
Clinical narrative: sleepiness; nausea; chills; night sweats; muscle aches/ increased muscle aches; mild headache/ moderate headache; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in arm right, administration date 25Mar2021 13:00 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. Relevant medical history included: "Asthma" (unspecified if ongoing); "Autoimmune disorder" (unspecified if ongoing); "known allergy to iodine intravenous (IV) contrast" (unspecified if ongoing); "known allergy to bee stings" (unspecified if ongoing). Concomitant medication included: fluticasone propionate, salmeterol xinafoate (ADVAIR, strength: 250/50, units not provided). Vaccination history included: BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE (dose 1, single; Batch/Lot number: unknown, vaccine location: left arm), administration date/time: 25Feb2021 at 01:00 PM, for COVID-19 immunization. The following information was reported: MYALGIA (non-serious) with onset 26Mar2021 13:00, outcome "recovered" (28Mar2021), described as "muscle aches/ increased muscle aches"; HEADACHE (non-serious) with onset 26Mar2021 13:00, outcome "recovered" (28Mar2021), described as "mild headache/ moderate headache"; SOMNOLENCE (non-serious) with onset 27Mar2021 13:00, outcome "recovered" (28Mar2021), described as "sleepiness"; NAUSEA (non-serious) with onset 27Mar2021 13:00, outcome "recovered" (28Mar2021), described as "nausea"; CHILLS (non-serious) with onset 27Mar2021 13:00, outcome "recovered" (28Mar2021), described as "chills"; NIGHT SWEATS (non-serious) with onset 27Mar2021 13:00, outcome "recovered" (28Mar2021), described as "night sweats." Therapeutic measures were not taken as a result of myalgia, headache, somnolence, nausea, chills, and night sweats.  Additional information: The facility where the most recent COVID-19 vaccine was administered was at the pharmacy or drug store. 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. There was an onset 24 hours after injection of muscle aches and mild headache. Side effects resolved approximately 42 hours after injection. Forty-eight (48) hours after injection, there was increased muscle aches, moderate headache, sleepiness, nausea, chills, and night sweats. Since the vaccination, the patient had not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected. Information about batch/lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: sleepiness; nausea; chills; night sweats; muscle aches/ increased muscle aches; mild headache/ moderate headache; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in arm right, administration date 25Mar2021 13:00 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. Relevant medical history included: "Asthma" (unspecified if ongoing); "Autoimmune disorder" (unspecified if ongoing); "known allergy to iodine intravenous (IV) contrast" (unspecified if ongoing); "known allergy to bee stings" (unspecified if ongoing). Concomitant medication included: fluticasone propionate, salmeterol xinafoate (ADVAIR, strength: 250/50, units not provided). Vaccination history included: BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE (dose 1, single; Batch/Lot number: unknown, vaccine location: left arm), administration date/time: 25Feb2021 at 01:00 PM, for COVID-19 immunization. The following information was reported: MYALGIA (non-serious) with onset 26Mar2021 13:00, outcome "recovered" (28Mar2021), described as "muscle aches/ increased muscle aches"; HEADACHE (non-serious) with onset 26Mar2021 13:00, outcome "recovered" (28Mar2021), described as "mild headache/ moderate headache"; SOMNOLENCE (non-serious) with onset 27Mar2021 13:00, outcome "recovered" (28Mar2021), described as "sleepiness"; NAUSEA (non-serious) with onset 27Mar2021 13:00, outcome "recovered" (28Mar2021), described as "nausea"; CHILLS (non-serious) with onset 27Mar2021 13:00, outcome "recovered" (28Mar2021), described as "chills"; NIGHT SWEATS (non-serious) with onset 27Mar2021 13:00, outcome "recovered" (28Mar2021), described as "night sweats." Therapeutic measures were not taken as a result of myalgia, headache, somnolence, nausea, chills, and night sweats.  Additional information: The facility where the most recent COVID-19 vaccine was administered was at the pharmacy or drug store. 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. There was an onset 24 hours after injection of muscle aches and mild headache. Side effects resolved approximately 42 hours after injection. Forty-eight (48) hours after injection, there was increased muscle aches, moderate headache, sleepiness, nausea, chills, and night sweats. Since the vaccination, the patient had not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected. Information about batch/lot number cannot be obtained.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Lactose intolerance
Clinical narrative: This is a spontaneous report received from contactable consumer (patient). A 69-year-old male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6204), at the age of 69, in left arm, on Mar 9, 2021, at 12:30, single dose, for COVID-19 immunisation. Medical history included high blood pressure (unspecified if ongoing); and asthma (unspecified if ongoing). Concomitant medications included: Zestril; simvastatin; Symbicort and hydrochlorothiazide. The patient developed lactose intolerance (developed lactose intolerance 1 week after injection), onset Mar 16, 2021, with outcome of not recovered. Therapeutic measures were taken as a result of lactose intolerance. Additional Information: The patient received sodium and a lactase enzyme (Lactaid) tablets as treatment for the event. The patient did not receive any other vaccines on the same date of COVID-19 vaccine, nor within 4 weeks prior. The patient took other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Malaise
Clinical narrative: dizziness; felt off in her head; felt sicker, and did not feel good; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.  An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 18Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "allergic to penicillin" (unspecified if ongoing); "sensitivity to some drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (dose 1, Batch/Lot number: unknown), for COVID-19 immunisation, reactions: "felt disoriented", "her head was not focused right", "dizzy". The following information was reported: DIZZINESS (non-serious) with onset 19Mar2021, outcome "unknown", described as "dizziness"; FEELING ABNORMAL (non-serious) with onset 19Mar2021, outcome "unknown", described as "felt off in her head"; MALAISE (non-serious) with onset 19Mar2021, outcome "unknown", described as "felt sicker, and did not feel good".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site pain
Clinical narrative: Right arm hurt where the injection was (10 hours after vaccination); light headed for 5 minutes; 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 male patient (reported as patient's age: 59; unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in right arm (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: DIZZINESS (non-serious), outcome "recovered", described as "light headed for 5 minutes"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Right arm hurt where the injection was (10 hours after vaccination)".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: the spot on her arm is red, hard and itchy; the spot on her arm is red, hard and itchy; the spot on her arm is red, hard and itchy; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 24Mar2021 (Batch/Lot number: unknown) at the age of 65 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: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE INDURATION (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 24Mar2021, outcome "unknown" and all described as "the spot on her arm is red, hard and itchy". Additional Information: The patient just got her Pfizer shot on Wednesday and since then she had hardness like in a circle about 2 inches all around and it's red, not real red, but red enough for her. She received her first dose of the Pfizer COVID-19 vaccine on Wednesday 24Mar2021. She stated that the spot on her arm is red, hard and itchy. Her friend who is a nurse looked at the injection site and advised her that she should report this to Pfizer. The caller stated that she wanted to know if she should take the second dose due to this reaction to the first dose. She has an appointment on Tuesday with her HCP and will ask for further guidance on proceeding with the second dose and treatment for the place on her arm at the injection site if it is still bothersome.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 49-year-old female patient (not pregnant) received the 1st dose, BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EL3247), at the age of 49, in left arm, on Mar 3, 2021, at 10:00, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had pain in extremity (after the first dose, left arm was sore for three days starting the day of the jab and the next two days), onset Mar 3, 2021, with outcome of recovered (Mar 2021). Therapeutic measures were not taken as a result of pain in extremity. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within 2 weeks of vaccination. No allergies to medications, food or other products. No known allergies. No COVID-19 prior vaccination, and not tested post vaccination. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Muscle tightness, Tension headache
Clinical narrative: feeling muscle tension in the back of her neck that spread up to her eyebrows; it was like a tension headache; discomfort; This is a spontaneous report received from a contactable consumer from medical information team.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 07Mar2021 (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: MUSCLE TIGHTNESS (non-serious) with onset Mar2021, outcome "unknown", described as "feeling muscle tension in the back of her neck that spread up to her eyebrows"; TENSION HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "it was like a tension headache"; DISCOMFORT (non-serious) with onset Mar2021, outcome "unknown", described as "discomfort".  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-2021335314 Same reporter, suspect drug and events; different patient
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Sleep disorder, Tinnitus
Clinical narrative: awoke from hearing music while napping; having "a buzzing in his ears"; left arm soreness; 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 70 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 03Mar2021 (Lot number: EN6201) at the age of 70 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "blood pressure" (unspecified if ongoing), notes: He only has high blood pressure and takes a medicine for that. The patient took concomitant medications.  The following information was reported: TINNITUS (non-serious) with onset 03Mar2021, outcome "unknown", described as "having "a buzzing in his ears""; PAIN IN EXTREMITY (non-serious) with onset 03Mar2021, outcome "unknown", described as "left arm soreness"; SLEEP DISORDER (non-serious) with onset 06Mar2021, outcome "recovered" (06Mar2021), described as "awoke from hearing music while napping". The event "having "a buzzing in his ears"" was evaluated at the physician office visit.  Additional information: The patient reported that he received his first COVID vaccine on 03Mar2021 and one day later began having a buzzing in his ears. He reported that it was a persistent buzzing and that it was worse when he is in a silent area and better when there are other noised around him. The patient reported that he received his second vaccine dose on 24Mar20221 and after that the buzzing increased a little bit, reduced but still irritating. The patient saw his general practitioner and was told he has no hearing deficit.  The patient had a mild feeling, later described as a soreness in the left arm that started 6 hours after the first dose and went away after 24 hours. It was just noticeable; it was not a problem. On 6Mar2021 while napping, he was awakened by what he thought was his device playing music. It sounded like elevator music. It was peculiar. It was a distinct sound of music that woke him up, but he saw that the device was off. This was alarming to him. The patient added that the physician scoped and looked into his ears and told him that he did not have a hearing disability. The physician told him to follow up with an ear, nose, and throat specialist. The patient stated it probably wouldn't make any difference and he did not need to take a hearing test. The patient added he is very healthy and has not had the flu for 12 years.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (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: SINUSITIS (non-serious), outcome "unknown", described as "sinus infection". The event "sinus infection" was evaluated at the physician office visit. Therapeutic measures were taken as a result of sinusitis. Additional information: The patient's doctor prescribed amoxicillin for her sinus infection and the patient wanted to know if it will cause a problem/interaction if she will receive the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Unable to sleep well/ can't get a full nights sleep/ just lay there wide awake/ Woke up at 4 am Friday. Didn't go to bed until 2 am Saturday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 25Mar2021 15:45 (Lot number: ER8727) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergies" (unspecified if ongoing), notes: Levocetirizine for allergies. Concomitant medication(s) included: LEVOCETIRIZIN taken for hypersensitivity; [ASCORBIC ACID; CYANOCOBALAMIN;ERGOCALCIFEROL; NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE MONONITRATE]. The following information was reported: INSOMNIA (non-serious) with onset 26Mar2021 04:00, outcome "not recovered", described as "Unable to sleep well/ can't get a full nights sleep/ just lay there wide awake/ Woke up at 4 am Friday. Didn't go to bed until 2 am Saturday". Therapeutic measures were not taken as a result of insomnia. 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 not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021355281 same report/drug/AE, different patient; US-PFIZER INC-2021355282 same report/drug/AE, different patient
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in upper left arm where shot was administered; 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 left, administration date 27Mar2021 10:45 (Lot number: EP6955) 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 none. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Mar2021 12:30, outcome "recovered" (Mar2021), described as "Pain in upper left arm where shot was administered". Therapeutic measures were not taken as a result of vaccination site pain. 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. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Confusional state, SARS-CoV-2 test
Clinical narrative: I'm still having some confusion; loss of memory; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 14Jan2021 11:45 (Lot number: Ek923) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Plaque psoriasis" (unspecified if ongoing), notes: Plaque Psoriasis arthritis; "Blood pressure high" (unspecified if ongoing), notes: high blood pressure; "Psoriatic arthritis" (unspecified if ongoing), notes: Plaque Psoriasis arthritis. The patient's concomitant medications were not reported. The following information was reported: AMNESIA (non-serious) with onset 03Feb2021, outcome "recovering", described as "loss of memory"; CONFUSIONAL STATE (non-serious), outcome "unknown", described as "I'm still having some confusion". The event "loss of memory" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The patient had no known allergies to medications, food, or other products. 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. On 03Feb2021, exactly 21 days after first dose, patient experienced loss of memory. The patient visited hospital and doctor could not find anything in her brain. The patient underwent lab test and procedure which included nasal swab test on 30Jan2021 and result was found to be negative. She slowly started to regain her memory back even though the she was still having some confusion.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021875223 same patient/drug, different vaccine dose/AE
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection Site sorenes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 49 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 22Mar2021 17:00 (Batch/Lot number: unknown) at the age of 49 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: VACCINATION SITE PAIN (non-serious) with onset 23Mar2021, outcome "recovering", described as "Injection Site soreness". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. It was also reported that the vaccine was given on Monday 22Mar2020.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Vomiting
Clinical narrative: Vomiting; Diarrhea; cold chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in arm left, administration date 23Mar2021 11:00 (Batch/Lot number: unknown) at the age of 75 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Diabetic for many years; "Seasonal allergies" (unspecified if ongoing), notes: diagnosed years ago; takes over the counter allergy medication when needed. The patient took concomitant medications. Vaccination history included: Shingles vaccine (Onset: 15Jan2021), administration date: 15Jan2021, when the patient was 75 years old, for immunization, reaction(s): "Chills", "Diarrhea", "Vomiting". The following information was reported: CHILLS (non-serious) with onset 23Mar2021, outcome "recovering", described as "cold chills"; VOMITING (non-serious) with onset 23Mar2021 18:00, outcome "recovering", described as "Vomiting"; DIARRHOEA (non-serious) with onset 23Mar2021 18:00, outcome "recovering", described as "Diarrhea". Additional information: The patient takes the same medications for years. The patient had no prior vaccination within 4 weeks. Chills started at around 15:00-16:00 and lasted until 24Mar2021 03:30. The patient could not get warm and claimed that it was the same side effects when she got the shingles shot but was worse. She threw up twice and got diarrhea 3-4 times. The events did not result in an emergency room or physician office visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 98.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest X-ray normal, Oral candidiasis, Pain, SARS-CoV-2 test positive
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 03/10/2021.  99 y/o with PMHX of HTN, HLD, CKD stage 3, peripheral neuropathy and recent fall with pelvic fracture presents to ED from SNF with c/o uncontrolled pain and oral thrush.  Pt afebrile, CXR -no acute process and requiring O2 at 2L NC.  Pt receiving IV hydration and pain management.
Age: 98.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 03/10/2021.  99 y/o with PMHX of HTN, HLD, CKD stage 3, peripheral neuropathy and recent fall with pelvic fracture presents to ED from SNF with c/o uncontrolled pain and oral thrush.  Pt afebrile, CXR -no acute process and requiring O2 at 2L NC.  Pt receiving IV hydration and pain management.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Mild, Additional Details: Mom does not want to provide any information as Dr is monitoring her health but wants to make sure issue gets resolved
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Ear swelling, Lymphadenopathy, Peripheral swelling, Photosensitivity reaction, Sunburn
Clinical narrative: sun poisoning; sunburn on hands and head; lymph, ears, hands swollen; lymph, ears, hands swollen; lymph, ears, hands swollen; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 12Mar2021 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PHOTOSENSITIVITY REACTION (non-serious) with onset 21Mar2021, outcome "unknown", described as "sun poisoning"; SUNBURN (non-serious) with onset 21Mar2021, outcome "unknown", described as "sunburn on hands and head"; LYMPHADENOPATHY (non-serious), PERIPHERAL SWELLING (non-serious), EAR SWELLING (non-serious) all with onset 21Mar2021, outcome "unknown" and all described as "lymph, ears, hands swollen". The events "sun poisoning", "sunburn on hands and head", and "lymph, ears, hands swollen" were evaluated at the physician office visit.  Additional information: On Sunday, 21Mar2021, the patient was just outside for an hour to hour and a half. He had a long sleeve shirt on. He got sunburn on hands and head, and his hands got swollen. He went to the doctor on 23Mar2021, and he said he had sun poisoning. None of his medications have changed in 4 years. His doctor said it was probably an adverse event to 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: Fatigue, Hypersomnia
Clinical narrative: extreme fatigue/ more tired and sleeping 12 hrs that night; more tired and sleeping 12 hrs that night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 23Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 23Mar2021, outcome "recovered" (24Mar2021), described as "extreme fatigue/ more tired and sleeping 12 hrs that night"; HYPERSOMNIA (non-serious) with onset 23Mar2021, outcome "recovered" (24Mar2021), described as "more tired and sleeping 12 hrs that night". Therapeutic measures were not taken as a result of fatigue, hypersomnia.  Additional event: Age: 61; Units: Unknown. The patient experienced extreme fatigue within 10 minutes of receiving the injection, becoming progressively more tired and sleeping 12 hrs that night. This fatigue lasted for two days and ended by the evening of the second day. It was unknown if patient received any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: chills; mild nausea; headache; body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 23Mar2021 09:30 (Lot number: EL3247) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "arm pain". The following information was reported: CHILLS (non-serious) with onset 24Mar2021 01:00, outcome "not recovered", described as "chills"; NAUSEA (non-serious) with onset 24Mar2021 01:00, outcome "not recovered", described as "mild nausea"; HEADACHE (non-serious) with onset 24Mar2021 01:00, outcome "not recovered", described as "headache"; PAIN (non-serious) with onset 24Mar2021 01:00, outcome "not recovered", described as "body ache". Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: was sick; 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.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "was sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Decreased appetite, Dizziness, Fatigue
Clinical narrative: Dizziness; Increased blood pressure; Headache; Loss of appetite; Tiredness; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 09:45 (Lot number: ER8732) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sleep apnea" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Heart problems" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing), notes: The patient reported unspecified allergies to medications, food, or other products. The patient took concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 26Mar2021 23:00, outcome "not recovered", described as "Dizziness"; BLOOD PRESSURE INCREASED (non-serious) with onset 26Mar2021 23:00, outcome "not recovered", described as "Increased blood pressure"; HEADACHE (non-serious) with onset 26Mar2021 23:00, outcome "not recovered", described as "Headache"; DECREASED APPETITE (non-serious) with onset 26Mar2021 23:00, outcome "not recovered", described as "Loss of appetite"; FATIGUE (non-serious) with onset 26Mar2021 23:00, outcome "not recovered", described as "Tiredness". The events "dizziness", "increased blood pressure", "headache", "loss of appetite" and "tiredness" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of dizziness, blood pressure increased, headache, decreased appetite, fatigue.  Additional Information: The reported age of patient was 64 with unspecified unit. The reporter classified the events as not serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Dizziness; Increased blood pressure; Headache; Loss of appetite; Tiredness; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 09:45 (Lot number: ER8732) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sleep apnea" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Heart problems" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing), notes: The patient reported unspecified allergies to medications, food, or other products. The patient took concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 26Mar2021 23:00, outcome "not recovered", described as "Dizziness"; BLOOD PRESSURE INCREASED (non-serious) with onset 26Mar2021 23:00, outcome "not recovered", described as "Increased blood pressure"; HEADACHE (non-serious) with onset 26Mar2021 23:00, outcome "not recovered", described as "Headache"; DECREASED APPETITE (non-serious) with onset 26Mar2021 23:00, outcome "not recovered", described as "Loss of appetite"; FATIGUE (non-serious) with onset 26Mar2021 23:00, outcome "not recovered", described as "Tiredness". The events "dizziness", "increased blood pressure", "headache", "loss of appetite" and "tiredness" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of dizziness, blood pressure increased, headache, decreased appetite, fatigue.  Additional Information: The reported age of patient was 64 with unspecified unit. The reporter classified the events as not serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: Cannot walk very well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. A 68-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: EP7534) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autoimmune disease" (unspecified if ongoing), "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol abnormal. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Cannot walk very well".  Additional information: Patient was calling to say that she got her first shot, the Pfizer vaccine. Her question, which she has looked everywhere and cannot find, is that she was put on Atorvastatin which is a cholesterol pill and she sees her doctor 01Apr2021 for prescheduling for her hip replacement. Her hip replacement is 24Apr2021. The doctor was going to draw cholesterol, caller clarified as blood work. She wanted to know if she can get the blood work done since she received the first vaccine. Caller requested RA medical information and stated that is where she thought she was being transferred to and she has been waiting 45 minutes. Caller was cold transferred with no agent on the line. This morning she received her shot. When probed for product details she mentioned she had to go get the card from the kitchen. Caller commented she cannot walk very well, walks with a cane, takes a while. Caller has an autoimmune disease and asked her surgeon if she should the vaccine. The surgeon said if she can get it, to get it. Her husband was also an essential worker, a food worker in a warehouse. Ten people in one warehouse, fifteen people in another warehouse, and truck drivers got covid. She was afraid that if she does not get the vaccine that maybe she would does not know. She was on the fence a long time and then she decided. Somewhere she heard that somebody got bloodwork the next day and it seemed that the white blood cell count was then up. She does not know where she saw this and she forgets. Caller lost 22 pounds and was feeling great but then Covid came and that was the end of that. Then was her hip and that makes it worse. She was going to get a new hip and dance and walk again. It was okay to contact the caller but it has to come up as Pfizer or she may not answer because she might think it is spam. She adds her doctor did not want her to get the shot, he was not on board with it. She does not think he knows. She does not want him to find out and then she will hear it from him.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021349652 same reporter/drug, different patient/event.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non HCP. A 44-year-old female patient (not pregnant) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 44, on Mar 23, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The following information patient developed a vaccination site mass (bump next to Band-Aid), onset Mar 23, 2021, with outcome of unknown. Therapeutic measures were not taken as a result of vaccination site mass. Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. Patient stated it may have been on the vaccine shot site but it was not under the Band-Aid. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I did not have much of a reaction after the first dose, just a sore arm.; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 05Mar2021 11:00 (Lot number: EN6205) at the age of 23 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy: Sulfa meds" (unspecified if ongoing); "Allergy: Egg" (unspecified if ongoing); "Allergy: cheese" (unspecified if ongoing); "Allergy: milk" (unspecified if ongoing); "Allergy: wheat" (unspecified if ongoing); "Allergy: gluten" (unspecified if ongoing); "Allergy: ragweed." (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Allergy: Amoxicillin". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I did not have much of a reaction after the first dose, just a sore arm.".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021336700 same patient/drug and different dose/event.