chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I'm going over circles and circles; I'm getting a headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (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: HEADACHE (non-serious), outcome "unknown", described as "I'm going over circles and circles; I'm getting a headache".   Additional information: Patient stated her 2nd dose was scheduled to the 01Apr2021 However she was unable to, so she now scheduled her 2nd dose for tomorrow on 08Apr2021. So she over now 21 days period. The patient was asking if it was ok because it was more than 3 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: felt some content out of the syringe trickle down her arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date 13Feb2021 (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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt some content out of the syringe trickle down her arm".  Response: Spoke from attached Document. Interim Recommendations for Covid-19 Vaccine Administration Errors and Deviations, under dosage "lower than authorized dose volume administered".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: night sweats; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) (patient's daughter) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (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: NIGHT SWEATS (non-serious) with onset 20Mar2021, outcome "unknown", described as "night sweats".  Additional information: The patient received her first Pfizer Covid vaccine on 16March2021. Around 20March2021, she started having night sweats, which caused her to change her clothes during the night. Consumer asked if the symptom was normal.  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: Condition aggravated, Pain, Pain in extremity
Clinical narrative: My right thumb is the worst, it's killing me.  My right hand is worse than my left hand.; My right thumb is the worst, it's killing me.  My right hand is worse than my left hand.; The pain is really bad; Due to the pain being really bad, she had to get up last night and put an ice pack but the pain got worse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 12:10 (Lot number: EW0162) at the age of 48 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number - 01, Lot number: ER2613 , Location: Left arm), administration date: 22Mar2021, when the patient was 48 years old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Apr2021, outcome "unknown" and all described as "My right thumb is the worst, it's killing me.  My right hand is worse than my left hand."; PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "The pain is really bad"; CONDITION AGGRAVATED (non-serious) with onset Apr2021, outcome "unknown", described as "Due to the pain being really bad, she had to get up last night and put an ice pack but the pain got worse". Therapeutic measures were taken as a result of pain in extremity, pain in extremity, pain, condition aggravated.  Additional Information: No additional vaccines administered on same date of the Pfizer suspect. No AE(s) require a visit to ER or MD office. If the patient was hospitalized, how many days was the hospital stay was not applicable. No prior vaccinations (within 4 weeks). No relevant tests. Caller state she had to stay at the facility after her Pfizer COVID Vaccines for each dose due to her allergies she was under observation.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Joint swelling, Peripheral swelling, Scrotal swelling
Clinical narrative: swelling in his feet, legs; swelling in his knees; swelling in his scrotum; unable to walk; 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 64 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Single, UNKNOWN MANUFACTURER), when the patient was 64 years old, for covid-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling in his feet, legs"; JOINT SWELLING (non-serious), outcome "unknown", described as "swelling in his knees"; SCROTAL SWELLING (non-serious), outcome "unknown", described as "swelling in his scrotum"; GAIT INABILITY (non-serious), outcome "unknown", described as "unable to walk". The events "swelling in his feet, legs", "swelling in his knees", "swelling in his scrotum" and "unable to walk" were evaluated at the physician office visit.  Additional information: The patient would be 65 years old in June and received the second dose of the Covid vaccine three weeks ago tomorrow. He received the vaccine at 9:10 a.m. that morning and by 3 in the afternoon he started experiencing swelling in his feet, legs, knees, and scrotum. His scrotum was in the size of a grapefruit and he pees all over himself due to the swelling covering his penis. He was unable to walk or put on pants due to the size of his scrotum and his girlfriend has to help raise his legs into bed due to the swelling. He was unable to get the swelling down and has consulted with his oncologist in which they do not know what to do for him either. And due to the chemo pills he takes, he has to drink 4 bottles of water every day, and the doctor does not want to give him Lasix due to the risk for his kidneys. He was miserable.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 55-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 55, in left arm, on Mar 17, 2021, at 18:00, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed fatigue (tired), onset Mar 17, 2021, with outcome of unknown; headache and nausea/nauseous, onset Mar 17, 2021, with outcome of not recovered. No therapeutic measures taken as a result of fatigue, headache and nausea. Additional information: Patient's left arm was sore. She was nauseous, had a headache and felt really, really tired for a couple of weeks. No treatment received. No COVID-19 diagnosis prior vaccination. No COVID-19 test post vaccination. No follow-up attempts possible. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Malaise, Nausea
Clinical narrative: Nausea; chills; has not been feeling well; Feel like been run over by a MAC truck; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 13:30 (Batch/Lot number: unknown) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "copd", start date: 2011 (ongoing), notes: she was diagnosed with beginning stages of COPD in 2011.; "had cancer removed", start date: 23Dec2020, stop date: 23Dec2020; "cancer" (not ongoing).There were no concomitant medications.  The following information was reported: HEADACHE (non-serious) with onset 09Apr2021, outcome "not recovered", described as "Headache"; NAUSEA (non-serious) with onset 11Apr2021, outcome "not recovered", described as "Nausea"; FEELING ABNORMAL (non-serious) with onset 09Apr2021, outcome "recovering", described as "Feel like been run over by a MAC truck"; CHILLS (non-serious) with onset 11Apr2021, outcome "not recovered", described as "chills"; MALAISE (non-serious) with onset 09Apr2021, outcome "unknown", described as "has not been feeling well".  Additional information: Patient received the covid vaccine on 9Apr2021. She would like to know how long will the symptoms last. The patient felt fine up until the night of Friday, 09Apr2021 and had not been feeling well since the night of Friday, 09Apr2021, after receiving the first dose of the Covid-19 vaccine that afternoon. She felt like she have been hit by a MAC truck and was feeling a little better but all she wants to do was sleep. She was at work and wasn't feeling well and ended up leaving her purse at work. So she was unable to provide product details as her vaccine card was in her purse. The patient reported that headache, nausea and chills were worsened. No Additional vaccines Administered. AE did not require a visit to Emergency Room and Physician Office. No Prior Vaccinations (within 4 weeks) and no AE following prior vaccinations. No Family Medical History Relevant to AE and no Relevant Tests.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Headache, Vaccination site pain
Clinical narrative: reports that sometime in between this shot and when her second dose is scheduled (19APR2021), her doctor gave her a Depo Medrol allergy shot; had "a little sore" arm; "little bit of a headache"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DEPO MEDROL taken for asthma, hypersensitivity. The following information was reported: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "reports that sometime in between this shot and when her second dose is scheduled (19APR2021), her doctor gave her a Depo Medrol allergy shot"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "had "a little sore" arm"; HEADACHE (non-serious), outcome "unknown", described as ""little bit of a headache"".  Additional Information: She states that she read online that she should have waited to get this shot 2-4 weeks after getting her second dose of the vaccine, and now would like to know if she is still safe to get the second dose on 19Apr2021.  Response: Spoke from the attached documents regarding contraindications to getting a dose of the vaccine and the caution of administering the vaccine to people with weakened immune systems, including those on medications that could weaken the immune system.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: has been severely sick since getting the vaccine; 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: ILLNESS (non-serious), outcome "unknown", described as "has been severely sick since getting the vaccine". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: wasn't feeling that good; This is a spontaneous report received from non-contactable consumer. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Batch/Lot number: unknown) at the age of 74 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunisation. The following information was reported: MALAISE (non-serious) with onset Apr2021, outcome "unknown", described as "wasn't feeling that good".  Additional information: patient reported that she didn't feel like talking today because she got her second dose of COVID-19 vaccination yesterday and wasn't feeling that good due to some of the side effects and symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Rhinorrhoea
Clinical narrative: he was experiencing runny nose and soaring eyes; he was experiencing runny nose and soaring eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (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: RHINORRHOEA (non-serious) with onset 2021, outcome "unknown", EYE PAIN (non-serious), outcome "unknown" and all described as "he was experiencing runny nose and soaring eyes".  Additional information: Reporter stated that the second dose scheduled on 08Apr2021, which was more than 21 days. The patient was experiencing runny nose and soaring eyes since yesterday. Reporter wanted to know if it was okay to get the second dose today.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache
Clinical narrative: no energy; Headaches; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Apr2021 (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: ASTHENIA (non-serious) with onset 12Apr2021, outcome "unknown", described as "no energy"; HEADACHE (non-serious) with onset 12Apr2021, outcome "unknown", described as "Headaches"; CHILLS (non-serious) with onset 12Apr2021, outcome "unknown", described as "chills".  Additional Information: The patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Treatment for AE was unknown. Covid prior vaccination was unknown. Covid tested post vaccination was unknown. List of any other medications the patient received within 2 weeks of vaccination was unknown. Treatment received for the adverse event was unknown. Prior to vaccination, the patient was diagnosed with COVID-19 was unknown. Since the vaccination, has the patient been tested for COVID-19 was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Sleep apnoea syndrome
Clinical narrative: headache; sleep apnea; 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 (159558). The reporter is the patient. A 25 year-old female patient received bnt162b2 (BNT162B2), administration date 09Apr2021 (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: HEADACHE (non-serious) with onset 13Apr2021, outcome "unknown", described as "headache"; SLEEP APNOEA SYNDROME (non-serious) with onset Apr2021, outcome "unknown", described as "sleep apnea". Therapeutic measures were not taken as a result of sleep apnoea syndrome.  Additional information: The patient received the first dose of the Pfizer COVID vaccine on Friday and today she had a headache. She would like to know if she can take Ibuprofen or not. She doesn't think it was coming from the vaccine and that she has sleep apnoea and didn't use her c-pap machine and when she woke up she had a headache.  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, Influenza like illness, Pain in extremity
Clinical narrative: arm soreness; flu like symptoms; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 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"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". 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, Feeling abnormal
Clinical narrative: brain fog; fatigue; 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fog"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  Additional information: Patient has no major underlying conditions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: severely fatigued; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 11:00 (Lot number: ER8727) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "bee sting allergy" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE. Past drug history included: Hydrocodone, reaction(s): "Drug allergy: Hydrocodone"; Levaquin, reaction(s): "Drug allergy: Levaquin". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "severely fatigued"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information : The first dose I had only a sore arm but, a couple of weeks later, was severely fatigued. With the 2nd dose my arm became red and swollen the next day. I also experienced chills muscle ache, headache, racing heart and total exhaustion. After 4 days, my arm is still red, swollen and itchy. Still exhausted with racing heartrate. If Covid prior vaccination reported as No and if Covid tested post vaccination was reported as No.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: First shot: Excessive thirst for 12 hrs; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jan2021 12:00 (Lot number: EL3302) at the age of 38 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: THIRST (non-serious) with onset Jan2021, outcome "recovered" (2021), described as "First shot: Excessive thirst for 12 hrs". Therapeutic measures were not taken as a result of thirst.  Additional information: The reporter considered the events as t non serious.patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient did not received any other medications within 2 weeks of vaccination.no treatment received for the adverse event. patient was not diagnosed with COVID-19 Prior to vaccination. Since the vaccination, patient has not been tested for COVID-19.patient was not Allergies to medications, food, or other products. Vaccine Facility information was available. Ethnicity information is available. Location of injection information is available for all vaccines received on the same date.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Testicular pain, Testicular swelling
Clinical narrative: Left testicle swollen and sore for a few days after first dose; Left testicle swollen and sore for a few days after first dose; 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 (BNT162B2), administered in arm left, administration date 19Mar2021 09:00 (Lot number: ER 2613) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: TESTICULAR SWELLING (non-serious), TESTICULAR PAIN (non-serious) all with onset 21Mar2021, outcome "recovered" (2021) and all described as "Left testicle swollen and sore for a few days after first dose". Therapeutic measures were not taken as a result of testicular swelling, testicular pain.  Additional information: The patient has no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at injection site; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 57 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 10Apr2021 16:00 (Lot number: EP6955) at the age of 57 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "elevated cholesterol" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "vitamin D deficiency" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM; ATORVASTATIN CALCIUM; LORATADINE; VITAMIN D [VITAMIN D NOS]; CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]. Past drug history included: Codeine, reaction(s): "drug allergy". Vaccination history included: BNT162B2 (lot number: EP6955, administration time: 16:00, administrator route: Intramuscular, vaccine location: Left arm, dose number: 1), administration date: 20Mar2021, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 10Apr2021 20:00, outcome "recovering", described as "Sore arm at injection site". Therapeutic measures were 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 COVID-19 vaccine. The patient received Tylenol and application of ice to the injection site as treatment for event.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Diarrhoea, Fatigue, Headache
Clinical narrative: extremely ill; sweating/body sweats; extreme abdominal pain; diarrhea; nausea; vomiting/vomiting bile; fatigued; Extreme headache; stomach cramping; copper taste left in my mouth like patients receiving chemo treatments; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021411940 (Pfizer).  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 15:45 (Lot number: EW0158) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Colitis" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: Eggs, cashews. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 10Apr2021 21:45, outcome "recovering", described as "extremely ill"; HYPERHIDROSIS (non-serious) with onset 10Apr2021 21:45, outcome "recovering", described as "sweating/body sweats"; ABDOMINAL PAIN (non-serious) with onset 10Apr2021 21:45, outcome "recovering", described as "extreme abdominal pain"; DIARRHOEA (non-serious) with onset 10Apr2021 21:45, outcome "recovering", described as "diarrhea"; NAUSEA (non-serious) with onset 10Apr2021 21:45, outcome "recovering", described as "nausea"; VOMITING (non-serious) with onset 10Apr2021 21:45, outcome "recovering", described as "vomiting/vomiting bile"; FATIGUE (non-serious) with onset 10Apr2021 21:45, outcome "recovering", described as "fatigued"; HEADACHE (non-serious) with onset 10Apr2021 21:45, outcome "recovering", described as "Extreme headache"; ABDOMINAL PAIN UPPER (non-serious) with onset 10Apr2021 21:45, outcome "recovering", described as "stomach cramping"; TASTE DISORDER (non-serious) with onset 10Apr2021 21:45, outcome "recovering", described as "copper taste left in my mouth like patients receiving chemo treatments". Therapeutic measures were not taken as a result of illness, hyperhidrosis, abdominal pain, diarrhoea, nausea, vomiting, fatigue, headache, abdominal pain upper, taste disorder.  Additional information: Patient states that in 48 hours after her 1st vaccine, she became extremely ill. she was sweating and head felt like it was in a vice. Had extreme abdominal pain, diarrhoea, nausea, vomiting bile that left a copper taste in my mouth that continued for another 48 hours. she was extremely fatigued and felt the side effects she experienced are extremely similar to chemotherapy. She was questioning getting the second round based on her violent experience with the first.  Facility type for vaccine administration was other. Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient did not have covid prior vaccination. Patient was not covid tested post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Illness, Nausea, Taste disorder, Vomiting
Clinical narrative: extremely ill; sweating/body sweats; extreme abdominal pain; diarrhea; nausea; vomiting/vomiting bile; fatigued; Extreme headache; stomach cramping; copper taste left in my mouth like patients receiving chemo treatments; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021411940 (Pfizer).  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 15:45 (Lot number: EW0158) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Colitis" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: Eggs, cashews. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 10Apr2021 21:45, outcome "recovering", described as "extremely ill"; HYPERHIDROSIS (non-serious) with onset 10Apr2021 21:45, outcome "recovering", described as "sweating/body sweats"; ABDOMINAL PAIN (non-serious) with onset 10Apr2021 21:45, outcome "recovering", described as "extreme abdominal pain"; DIARRHOEA (non-serious) with onset 10Apr2021 21:45, outcome "recovering", described as "diarrhea"; NAUSEA (non-serious) with onset 10Apr2021 21:45, outcome "recovering", described as "nausea"; VOMITING (non-serious) with onset 10Apr2021 21:45, outcome "recovering", described as "vomiting/vomiting bile"; FATIGUE (non-serious) with onset 10Apr2021 21:45, outcome "recovering", described as "fatigued"; HEADACHE (non-serious) with onset 10Apr2021 21:45, outcome "recovering", described as "Extreme headache"; ABDOMINAL PAIN UPPER (non-serious) with onset 10Apr2021 21:45, outcome "recovering", described as "stomach cramping"; TASTE DISORDER (non-serious) with onset 10Apr2021 21:45, outcome "recovering", described as "copper taste left in my mouth like patients receiving chemo treatments". Therapeutic measures were not taken as a result of illness, hyperhidrosis, abdominal pain, diarrhoea, nausea, vomiting, fatigue, headache, abdominal pain upper, taste disorder.  Additional information: Patient states that in 48 hours after her 1st vaccine, she became extremely ill. she was sweating and head felt like it was in a vice. Had extreme abdominal pain, diarrhoea, nausea, vomiting bile that left a copper taste in my mouth that continued for another 48 hours. she was extremely fatigued and felt the side effects she experienced are extremely similar to chemotherapy. She was questioning getting the second round based on her violent experience with the first.  Facility type for vaccine administration was other. Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient did not have covid prior vaccination. Patient was not covid tested post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Testicular swelling
Clinical narrative: Left testicle swollen; 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 (BNT162B2), administered in arm left, administration date 09Apr2021 08:30 (Lot number: ER 8729) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Lot number: ER2613 in left arm at 09:00 as dose 1, single), administration date: 19Mar2021, when the patient was 46 years old, for COVID-19 immunisation, reaction(s): "left testicle swollen", "left testicle sore". The following information was reported: TESTICULAR SWELLING (non-serious), outcome "not recovered", described as "Left testicle swollen". Therapeutic measures were not taken as a result of testicular swelling.  Additional information: The patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Strong metal taste; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 19Mar2021 10:30 (Lot number: ENW99) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sjogren's syndrome" (unspecified if ongoing). Concomitant medication included: PLAQUENIL. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The following information was reported: DYSGEUSIA (non-serious) with onset 19Mar2021, outcome "not recovered", described as "Strong metal taste".  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Oral candidiasis, Oral discomfort
Clinical narrative: Strong metal taste in my mouth.  Started after the 1 dose.  But now, after the second dose, it is much more pronounced.; My tongue is covered with a white pus-like substance/oral thrush; My entire mouth cavity feels like I drank a very hot liquid that burned my month; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 11:00 (Lot number: EW0150) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sjogrens syndrome" (unspecified if ongoing). Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]. Vaccination history included: Bnt162b2 (lot number: ENW99,, administration time: 10:30 AM, vaccine location: Left arm, dose number: 1), administration date: 19Mar2021, for COVID-19 immunisation, reaction(s): "Strong metal taste in my mouth". The following information was reported: DYSGEUSIA (non-serious), outcome "not recovered", described as "Strong metal taste in my mouth.  Started after the 1 dose.  But now, after the second dose, it is much more pronounced."; ORAL CANDIDIASIS (non-serious), outcome "not recovered", described as "My tongue is covered with a white pus-like substance/oral thrush"; ORAL DISCOMFORT (non-serious), outcome "not recovered", described as "My entire mouth cavity feels like I drank a very hot liquid that burned my month". The events "strong metal taste in my mouth.  started after the 1 dose.  but now, after the second dose, it is much more pronounced.", "my tongue is covered with a white pus-like substance/oral thrush" and "my entire mouth cavity feels like i drank a very hot liquid that burned my month" were evaluated at the physician office visit. Therapeutic measures were taken as a result of dysgeusia, oral candidiasis, oral discomfort.  Additional information: the patient had no other vaccine in four weeks. Strong metal taste in her mouth. Started after the 1 dose. But now, after the second dose, it was much more pronounced. Her tongue was covered with a white pus-like substance. Her entire mouth cavity felt like she drank a very hot liquid that burned her month. Treatment for oral thrush with oregano. The patient had no covid prior vaccination. She was not covid tested post vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Neutrophil count, Neutrophil count increased
Clinical narrative: Neutrophils count are higher than normal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUTROPHIL COUNT INCREASED (non-serious), outcome "unknown", described as "Neutrophils count are higher than normal". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient took the COVID vaccine and noticed had a blood test few weeks later which resulted neutrophils count were higher than normal.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigued; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 10:45 (Batch/Lot number: unknown) at the age of 26 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 31Mar2021 13:00, outcome "recovered" (2021), described as "fatigued". Therapeutic measures were not taken as a result of fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Loss of personal independence in daily activities, Pain
Clinical narrative: pain in in bicep area traveled to her right wrist; difficulty doing certain things; 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 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 08:20 (Lot number: EN6198) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lyme disease", start date: Aug2020 (unspecified if ongoing), notes: she has a history of Lyme disease last year in Aug2020; "knee pain" (unspecified if ongoing); "trouble sleeping" (unspecified if ongoing), notes: she is a side sleeper; "flu shot" (unspecified if ongoing); "allergic to thimerosal" (unspecified if ongoing), notes: allergic to thimerosal. Caller states this was years ago,. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01, Batch/lot number: EL9266, anatomical location : Right arm, time at vaccination :08:20 AM), administration date: 25Feb2021, when the patient was 71 years old, for COVID-19 Immunization, reaction(s): "she had right arm pain at the injection site". The following information was reported: PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "pain in in bicep area travelled to her right wrist"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Mar2021, outcome "unknown", described as "difficulty doing certain things". The events "pain in in bicep area travelled to her right wrist" and "difficulty doing certain things" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, loss of personal independence in daily activities (ibuprofen)  Additional information: Patient received her second dose in the same arm (right arm) on 18Mar2021. 6 to 7 days later the pain in in bicep area travelled to her right wrist Patient states after that second dose her arm just got worse, states it was all the way down her arm and her right wrist was even bothering her, it was difficult for her to do things, and then it started on her left arm, states the left arm was no where near the severity as it was on the right side but it was so bad she could not hook her bra. Patient did not take any other products. she was wanting to go through her scenario of getting her shots and see if any one was experiencing what she was. Caller clarifies she received the Pfizer Covid vaccines. NDC number of Covid vaccine was unknown. Patient reported she had been in physical therapy for knee pain and now they were giving her exercises for her arm pain. She wanted to know any information Pfizer might have on this.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pigmentation disorder
Clinical narrative: discoloration in the pigment of the skin on her hands, particularly on her fingers; This is a spontaneous report received from a 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 09Apr2021 at 14:15 (Lot number: EW0151) at the age of 68 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Graves' Disease" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Low blood platelets" (unspecified if ongoing). Concomitant medications included: METHIMAZOLE; D3; VIT K1; ZINC; VIT C; TR CARE. Past drug history included: Augmentin, reaction: "Allergies". Vaccination history included: BNT162b2 (Dose 1, Lot # EN6207, in left arm at 07:45 AM), administration date: 19Mar2021, when the patient was 68 years old, for COVID-19 immunization, reactions: "discoloration in the pigment of her skin on her hands, particularly on her fingers" and "pain in my hands". The following information was reported: PIGMENTATION DISORDER (non-serious) with onset 11Apr2021 02:00, outcome "recovering", described as "discoloration in the pigment of the skin on her hands, particularly on her fingers". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pigmentation disorder.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that after both vaccine shots, she had discoloration in the pigment of the skin on her hands, particularly on her fingers. After her second shot, the discoloration appeared 2 days after the vaccine. There was no pain, and the discoloration was only on her knuckles and fingers, not her whole hand. She was wondering if this was an expected side effect. There was no treatment received for the adverse event.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021394797 same reporter/patient/vaccine, different dose and similar event
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance, Insomnia, Pain in extremity
Clinical narrative: I couldn't even walk aching around my lower back, it went down to my leg, my leg was aching so bad; I couldn't even walk aching around my lower back, it went down to my leg, my leg was aching so bad; I couldn't even walk aching around my lower back, it went down to my leg, my leg was aching so bad; I couldn't sleep at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious), PAIN IN EXTREMITY (non-serious), BACK PAIN (non-serious), outcome "unknown" and all described as "I couldn't even walk aching around my lower back, it went down to my leg, my leg was aching so bad"; INSOMNIA (non-serious), outcome "unknown", described as "I couldn't sleep at night".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: My wife also experienced a minor reaction after her 1st shot.  The small lymph node under her jaw was a bit swollen.  It hasn't disappeared yet; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm left (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: LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "My wife also experienced a minor reaction after her 1st shot.  The small lymph node under her jaw was a bit swollen. It hasn't disappeared yet".  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 in extremity
Clinical narrative: her arm hurt; 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 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 "her arm hurt".  Additional information: The patient's age was reported as 87, no unit provided.  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-2021392759 Same reporter/drug/AE, different patient;US-PFIZER INC-2021407626 Same reporter/drug, different patient/AE