chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site for both doses after 4 hours of dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 08:30 (Lot number: EN6206) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Citrus foods" (unspecified if ongoing), notes: known allergies: Citrus foods. Concomitant medication(s) included: PHENTERMINE. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 10Mar2021 12:30, outcome "recovered", described as "Soreness at injection site for both doses after 4 hours of dose". Therapeutic measures were taken as a result of vaccination site pain.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Effusion, Neck pain, Pain in extremity, Spinal pain
Clinical narrative: feels like fluid build up in center of back of neck at top of spine; tenderness in arm, neck and spine was reported as worsened; tenderness in arm, neck and spine; tenderness in arm, neck and spine; tenderness in arm, neck and spine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 08:30 (Lot number: ER8730, Expiration Date: 31Jul2021) at the age of 37 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: PAIN IN EXTREMITY (non-serious), NECK PAIN (non-serious), SPINAL PAIN (non-serious) all with onset 30Mar2021, outcome "not recovered" and all described as "tenderness in arm, neck and spine"; EFFUSION (non-serious) with onset 31Mar2021, outcome "not recovered", described as "feels like fluid build up in center of back of neck at top of spine"; CONDITION AGGRAVATED (non-serious) with onset 31Mar2021, outcome "unknown", described as "tenderness in arm, neck and spine was reported as worsened".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain in extremity
Clinical narrative: Terrible colds; Sore arm; 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.  An 85-year-old female patient received BNT162B2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 2021, outcome "unknown", described as "Terrible colds"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Sore arm". Additional information: The patient was concerned what she should do since her second dose was scheduled at the time of the report. She was experiencing terrible colds and also after her first dose she experienced sore arm. So, that was why she asked if she should continue getting her second dose that day or should she wait (a week) until she felt better. She lives two hours from where vaccination site, but she was just not feeling up to a two-hour drive due to the terrible cold.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 25-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Mar2021 09:15 (Lot number: EN6207) at the age of 25 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Moderate-severe asthma" (unspecified if ongoing); "Only animal allergies" (unspecified if ongoing). Concomitant medication(s) included: SPRINTEC; WELLBUTRIN. Vaccination history included: Tetanus shot (I am feeling similar to how I did the day after getting my tetanus shot this summer, where my lower body was in extreme pain and even temperature changes or wind would cause pain in my legs.), administration date: 2021, for Immunisation, reaction(s): "lower body was in extreme pain", "pain in my legs". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional Information: The patient had no reaction after the first vaccine other than sore arm. She was feeling similar to how did the day after getting my TETANUS shot this summer, where her lower body was in extreme pain and even temperature changes or wind would cause pain in her legs. She had known allergies to only animal. Other medical history included moderate to severe asthma. She had no other vaccine in four weeks. Other medications in two weeks: SPRINTEC, WELLBUTRIN XR 300 milligram. She did not have COVID-19 prior to vaccination. Post the vaccination, was not tested for COVID-19. No treatment was received for the adverse event.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria, Poor quality sleep
Clinical narrative: urinating constantly; up all night; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administration date 28Mar2021 (Lot number: ER2613) at the age of 75 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Hot flashes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot number: EN6199; in shoulder as dose 1, single), administration date: 05Mar2021, when the patient was 75 years old, for COVID-19 immunisation, reaction(s): "Diarrhea". The following information was reported: POLLAKIURIA (non-serious) with onset 28Mar2021, outcome "not recovered", described as "urinating constantly"; POOR QUALITY SLEEP (non-serious) with onset 28Mar2021, outcome "unknown", described as "up all night".  Additional information: Vaccine was administered in the shoulder (as reported). It was reported that the patient got her last shot on Sunday (28Mar2021) and has been urinating constantly, up all night, back and forth.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021369170 Same reporter, drug and event; different patient
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Diarrhoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: really bad diarrhea all day; Splitting headache; Cold Sweats; shaking real bad; didn't feel too great; tired; Sluggish; Had a little bit of body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 37 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 (Lot number: EP7534) at the age of 37 years 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) with onset 25Mar2021, outcome "unknown", described as "didn't feel too great"; FATIGUE (non-serious) with onset 25Mar2021, outcome "unknown", described as "tired"; SLUGGISHNESS (non-serious) with onset 25Mar2021, outcome "unknown", described as "Sluggish"; PAIN (non-serious) with onset 25Mar2021, outcome "unknown", described as "Had a little bit of body aches"; DIARRHOEA (non-serious) with onset 31Mar2021, outcome "recovered" (31Mar2021), described as "really bad diarrhea all day"; HEADACHE (non-serious) with onset 31Mar2021, outcome "recovered" (31Mar2021), described as "Splitting headache"; COLD SWEAT (non-serious) with onset 31Mar2021, outcome "recovered" (31Mar2021), described as "Cold Sweats"; TREMOR (non-serious) with onset 31Mar2021, outcome "recovered" (31Mar2021), described as "shaking real bad".  Additional information: The patient was not visit to Emergency Room and Physician Office. 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Sluggishness, Tremor
Clinical narrative: really bad diarrhea all day; Splitting headache; Cold Sweats; shaking real bad; didn't feel too great; tired; Sluggish; Had a little bit of body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 37 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 (Lot number: EP7534) at the age of 37 years 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) with onset 25Mar2021, outcome "unknown", described as "didn't feel too great"; FATIGUE (non-serious) with onset 25Mar2021, outcome "unknown", described as "tired"; SLUGGISHNESS (non-serious) with onset 25Mar2021, outcome "unknown", described as "Sluggish"; PAIN (non-serious) with onset 25Mar2021, outcome "unknown", described as "Had a little bit of body aches"; DIARRHOEA (non-serious) with onset 31Mar2021, outcome "recovered" (31Mar2021), described as "really bad diarrhea all day"; HEADACHE (non-serious) with onset 31Mar2021, outcome "recovered" (31Mar2021), described as "Splitting headache"; COLD SWEAT (non-serious) with onset 31Mar2021, outcome "recovered" (31Mar2021), described as "Cold Sweats"; TREMOR (non-serious) with onset 31Mar2021, outcome "recovered" (31Mar2021), described as "shaking real bad".  Additional information: The patient was not visit to Emergency Room and Physician Office. 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: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in his arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "soreness in his arm". 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: Diarrhoea
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (patient). A 75-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6199), at the age of 75, on Mar 5, 2021, single dose, for COVID-19 immunisation. Medical history included arthritis (unspecified if ongoing); and hot flashes (unspecified if ongoing). No concomitant medications. The patient had diarrhea, onset Mar 6, 2021, with outcome of recovered (Mar 10, 2021). Additional information: Vaccine administered in the shoulder. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the injection site (right arm); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 19 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 (Lot number: EP6955) 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 31Mar2021 22:00, outcome "recovered" (02Apr2021 09:00), described as "Pain at the injection site (right arm)".  Additional information: Intensity: Mild. Reporter mentioned that patient woke up on 02Apr21 and the pain was gone.  No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Feeling cold, Feeling hot
Clinical narrative: I have no energy; dizzy / I didn't go down in the basement steps because I figured out  that I will pass out if I get down there; restless; slept a lot; I was really hot; tired / slept all day; got really cold couldn't get warm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Lot number: ER2613) at the age of 72 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation, reaction(s): "Didn't have side effects". The following information was reported: FEELING COLD (non-serious) with onset 20Mar2021, outcome "recovered" (23Mar2021), described as "got really cold couldn't get warm"; FEELING HOT (non-serious) with onset 21Mar2021, outcome "recovered" (23Mar2021), described as "I was really hot"; FATIGUE (non-serious) with onset 21Mar2021, outcome "recovered" (23Mar2021), described as "tired / slept all day"; RESTLESSNESS (non-serious) with onset 22Mar2021, outcome "recovered" (23Mar2021), described as "restless"; HYPERSOMNIA (non-serious) with onset 22Mar2021, outcome "recovered" (23Mar2021), described as "slept a lot"; ASTHENIA (non-serious) with onset 23Mar2021, outcome "recovered" (23Mar2021), described as "I have no energy"; DIZZINESS (non-serious) with onset 23Mar2021, outcome "recovered" (23Mar2021), described as "dizzy / I didn'tgo down in the basement steps because I figured out  that I will pass out if I get down there". Therapeutic measures were not taken as a result of feeling cold, feeling hot, fatigue, restlessness, hypersomnia, asthenia, dizziness.  Additional information: The patient also had Synthetic fibroid 75 mcg daily as concomitant medication.   No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Restlessness
Clinical narrative: I have no energy; dizzy / I didn't go down in the basement steps because I figured out  that I will pass out if I get down there; restless; slept a lot; I was really hot; tired / slept all day; got really cold couldn't get warm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Lot number: ER2613) at the age of 72 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation, reaction(s): "Didn't have side effects". The following information was reported: FEELING COLD (non-serious) with onset 20Mar2021, outcome "recovered" (23Mar2021), described as "got really cold couldn't get warm"; FEELING HOT (non-serious) with onset 21Mar2021, outcome "recovered" (23Mar2021), described as "I was really hot"; FATIGUE (non-serious) with onset 21Mar2021, outcome "recovered" (23Mar2021), described as "tired / slept all day"; RESTLESSNESS (non-serious) with onset 22Mar2021, outcome "recovered" (23Mar2021), described as "restless"; HYPERSOMNIA (non-serious) with onset 22Mar2021, outcome "recovered" (23Mar2021), described as "slept a lot"; ASTHENIA (non-serious) with onset 23Mar2021, outcome "recovered" (23Mar2021), described as "I have no energy"; DIZZINESS (non-serious) with onset 23Mar2021, outcome "recovered" (23Mar2021), described as "dizzy / I didn'tgo down in the basement steps because I figured out  that I will pass out if I get down there". Therapeutic measures were not taken as a result of feeling cold, feeling hot, fatigue, restlessness, hypersomnia, asthenia, dizziness.  Additional information: The patient also had Synthetic fibroid 75 mcg daily as concomitant medication.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: 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: Ear disorder, Fatigue, Headache, Oropharyngeal pain, Somnolence
Clinical narrative: I fell asleep; Terrible headache; Sore throat; fatigue; felt like someone was stabbing me in the ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). 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: SOMNOLENCE (non-serious), outcome "unknown", described as "I fell asleep"; HEADACHE (non-serious), outcome "unknown", described as "Terrible headache"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sore throat"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; EAR DISORDER (non-serious), outcome "unknown", described as "felt like someone was stabbing me in the ear".  Additional information: Patient received first covid vaccine on Monday. On Tuesday patient felt asleep on the floor of the class for a half an hour while the kids were at recess. By Wednesday patient had a terrible headache, sore throat, fatigue and it felt like someone was stabbing in the ear. Patient concern is should patient get the second vaccine if the symptoms of the first are so bad.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Product administered at inappropriate site
Clinical narrative: went to have my second vaccination and she hit my shoulder blade, right at the bone; cannot move my right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in the shoulder blade, administration date 30Mar2021 (Lot number: ER8733) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 30Mar2021, outcome "unknown", described as "went to have my second vaccination and she hit my shoulder blade, right at the bone"; MOVEMENT DISORDER (non-serious) with onset 30Mar2021, outcome "unknown", described as "cannot move my right arm". Additional information: The patient went to have her second vaccination and she (who administered the vaccine) hit her shoulder blade, right at the bone. She cannot move her right arm. The patient asked whether she should go back and get another shot. She did not take any treatment.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Tremor
Clinical narrative: arms and hands is shaking like a tiny spasm; arms and hands is shaking like a tiny spasm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious), TREMOR (non-serious), outcome "unknown" and all described as "arms and hands is shaking like a tiny spasm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: had water blisters on my face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Lot number: ER8730, Expiration Date: 31Jul2021) at the age of 49 years 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: BLISTER (non-serious) with onset 31Mar2021, outcome "not recovered", described as "had water blisters on my face". Therapeutic measures were not taken as a result of blister.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness
Clinical narrative: Flu like symptoms; foggy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Product: COVID-19,, Lot unknown: False,, Dose number-1), for covid-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "foggy". It was unknown if therapeutic measures were taken as a result of influenza like illness, feeling abnormal. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Influenza
Clinical narrative: having big time flu symptoms; he was really sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 03Apr2021 (Lot number: ER8730) 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: INFLUENZA (non-serious) with onset 2021, outcome "unknown", described as "having big time flu symptoms"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "he was really sick".  Additional information: The reporter stated that her son received the first dose of the Pfizer covid 19 vaccine on 3Apr2021 and is having big time flu symptoms. The reporter wanted to know how they should last and should he get there other shot. Reporter stated that her son had the Pfizer vaccine (Unspecified Vaccine) on Saturday and he was having big time flu symptoms and they started Sunday and Monday, he was really sick and today he is really sick.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Confusional state, Fatigue, Malaise, Pain in extremity
Clinical narrative: She is upset and confused.; She is upset and confused.; sore arm; fatigue; 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 female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 (Lot number: ER8733, Expiration Date: 31Jul2021) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 31Mar2021, outcome "unknown", described as "sore arm"; FATIGUE (non-serious) with onset 31Mar2021, outcome "unknown", described as "fatigue"; MALAISE (non-serious), CONFUSIONAL STATE (non-serious), outcome "unknown" and all described as "She is upset and confused.". It was unknown if therapeutic measures were taken as a result of pain in extremity, fatigue. First time caller, consumer went to get her first covax which was Pfizer. 6 days later the vaccination site. called her and said that she only received saline injection. They gave her 2 options, start over with J&J vaccine or get second covax as scheduled. She states she went to her HCP because her arm was sore and she had fatigue. So her HCP told her she must had gotten the Pfizer covax. Now she was confused as to what she should do. Told her if she did get Pfizer covax cannot interchange. She was upset and confused.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021379471 Same reporter/ drug, different AE/ patient;US-PFIZER INC-2021379474 Same reporter/ drug, different AE/ patient
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain in extremity, Product preparation error
Clinical narrative: She is upset and confused.; She is upset and confused.; sore arm; fatigue; 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 female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 (Lot number: ER8733, Expiration Date: 31Jul2021) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 31Mar2021, outcome "unknown", described as "sore arm"; FATIGUE (non-serious) with onset 31Mar2021, outcome "unknown", described as "fatigue"; MALAISE (non-serious), CONFUSIONAL STATE (non-serious), outcome "unknown" and all described as "She is upset and confused.". It was unknown if therapeutic measures were taken as a result of pain in extremity, fatigue. First time caller, consumer went to get her first covax which was Pfizer. 6 days later the vaccination site. called her and said that she only received saline injection. They gave her 2 options, start over with J&J vaccine or get second covax as scheduled. She states she went to her HCP because her arm was sore and she had fatigue. So her HCP told her she must had gotten the Pfizer covax. Now she was confused as to what she should do. Told her if she did get Pfizer covax cannot interchange. She was upset and confused.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021379471 Same reporter/ drug, different AE/ patient;US-PFIZER INC-2021379474 Same reporter/ drug, different AE/ patient
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Confusional state, Fatigue, Malaise, Pain in extremity
Clinical narrative: 6 out of 98 participants were injected with saline only; Sore arm; Fatigue; 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 female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 (Lot number: ER8733, Expiration Date: 31Jul2021) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Surgery" (unspecified if ongoing), notes: she was recovering from major surgery, clarified she had surgery in February. There were no concomitant medications. The following information was reported: PRODUCT PREPARATION ERROR (non-serious) with onset 31Mar2021, outcome "unknown", described as "6 out of 98 participants were injected with saline only"; PAIN IN EXTREMITY (non-serious) with onset 31Mar2021, outcome "unknown", described as "Sore arm"; FATIGUE (non-serious) with onset 31Mar2021, outcome "unknown", described as "Fatigue".  Additional information: Patient did not receive other vaccination within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021375953 Same reporter/ drug, different AE/ patient ;US-PFIZER INC-2021379469 Same reporter/product/event, different patient
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain in extremity, Product preparation error
Clinical narrative: 6 out of 98 participants were injected with saline only; Sore arm; Fatigue; 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 female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 (Lot number: ER8733, Expiration Date: 31Jul2021) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Surgery" (unspecified if ongoing), notes: she was recovering from major surgery, clarified she had surgery in February. There were no concomitant medications. The following information was reported: PRODUCT PREPARATION ERROR (non-serious) with onset 31Mar2021, outcome "unknown", described as "6 out of 98 participants were injected with saline only"; PAIN IN EXTREMITY (non-serious) with onset 31Mar2021, outcome "unknown", described as "Sore arm"; FATIGUE (non-serious) with onset 31Mar2021, outcome "unknown", described as "Fatigue".  Additional information: Patient did not receive other vaccination within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021375953 Same reporter/ drug, different AE/ patient ;US-PFIZER INC-2021379469 Same reporter/product/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: My arm for the last two weeks has been very sore, it is hard to move around like above my head; My arm for the last two weeks has been very sore, it is hard to move around like above my head; 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 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: PAIN IN EXTREMITY (non-serious), INJECTED LIMB MOBILITY DECREASED (non-serious), outcome "unknown" and all described as "My arm for the last two weeks has been very sore, it is hard to move around like above my head". Therapeutic measures were not taken as a result of pain in extremity, injected limb mobility decreased.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: One of the side effects is swelling at the site of the injection site, however it's been one week and it's still swollen; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJECTION SITE SWELLING (non-serious), outcome "unknown", described as "One of the side effects is swelling at the site of the injection site, however it's been one week and it's still swollen".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: he has been sweating profusely; 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 male 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: HYPERHIDROSIS (non-serious), outcome "unknown", described as "he has been sweating profusely".  Additional information: Clinical course: It was reported that patient has been sweating profusely since he received the first dose of the Pfizer COVID-19 vaccine about two and a half weeks ago. He wants to know if this is normal to experience side effects for this length of time. Patient states that he was due to receive the second dose of the Pfizer COVID-19 vaccine soon and he was concerned about receiving it considering the adverse reaction he had after the first dose. Patient wants to know could this reaction be because of some of the prescription medications that he taken.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Vaccination site pain
Clinical narrative: Arm soreness at injection site; soreness / armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Arm soreness at injection site"; AXILLARY PAIN (non-serious), outcome "unknown", described as "soreness / armpit". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Fall, Gait disturbance
Clinical narrative: first vaccine feb 27th was scheduled on march 20th and couldnt make appointment; he had fallen; couldn't hardly walk; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (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: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "first vaccine feb 27th was scheduled on march 20th and couldnt make appointment"; FALL (non-serious), outcome "unknown", described as "he had fallen"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "couldn't hardly walk".  Additional Information: A patient received first vaccine 27Feb was scheduled on march 20Mar and couldn't make appointment because he had fallen and couldn't hardly walk. Wanted to schedule a second appointment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: body ache; headache; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 56 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 56 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Pain" (unspecified if ongoing), notes: pre-existing pain has subsided, mobility is better and no longer, taking gabapentin; "Neurological Itching" (unspecified if ongoing); "rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "recovered", described as "body ache"; HEADACHE (non-serious), outcome "recovered", described as "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper
Clinical narrative: gastrointestinal; stomach aches for 3-4 days; 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 male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization.   The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "gastrointestinal"; ABDOMINAL PAIN UPPER (non-serious), outcome "recovered", described as "stomach aches for 3-4 days".  Additional information: The patient stated he took the first dose of the Pfizer covid vaccine and experienced minor symptoms, gastrointestinal, stomach aches for 3-4 days. Patient was concerned about getting the second dose and stated that he might not get it due to flu like symptoms after it. patient wanted to know how long the protection may last. The patient wanted to know the efficacy after the first dose and also who should not get the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fall, Skin laceration
Clinical narrative: fell; got a cut with a rusty nail; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male 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: FALL (non-serious), outcome "unknown", described as "fell"; SKIN LACERATION (non-serious), outcome "unknown", described as "got a cut with a rusty nail". Therapeutic measures were taken as a result of skin laceration.  Additional information: It was reported that week after vaccination, he fell; and got a cut with a rusty nail and got a tetanus shot from that. Patient could not get the second dose because he got the tetanus. Patient wanted to see what would be the process to get the second dose of covid vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I also had a mild headache after the first shot for a week or two; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 08:45 (Lot number: en6199) as dose 1, single for covid-19 immunisation. Relevant medical history included: "mild, cough-variant asthma" (unspecified if ongoing); "Hay fever" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN B [VITAMIN B COMPLEX]. The following information was reported: HEADACHE (non-serious), outcome "recovering", described as "I also had a mild headache after the first shot for a week or two". Therapeutic measures were not taken as a result of headache.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Potentiating drug interaction
Clinical narrative: tiredness; Caller is taking blood thinner as his maintenance and wants to know the possible side effects; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program (159558). The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administration date 06Apr2021 08:30 (Lot number: ER8733) 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: FATIGUE (non-serious), outcome "unknown", described as "tiredness"; POTENTIATING DRUG INTERACTION (non-serious), outcome "unknown", described as "Caller is taking blood thinner as his maintenance and wants to know the possible side effects".  Additional information: When vaccinating Persons with Increased Bleeding Risk, providers often avoid giving intramuscular injections (not just this vaccine) or choose alternative routes because of the risk for hematoma formation after injections.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Influenza like illness, Malaise, Vaccination site pain, Vomiting
Clinical narrative: hot and cold flu-like" condition; diarrhea; vomiting; little soreness in his arm, where he had the shot; did not feel good; 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 62-years-old male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 14:30 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 31Mar2021, outcome "unknown", described as "did not feel good"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "hot and cold flu-like" condition"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhoea"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; VACCINATION SITE PAIN (non-serious) with onset 31Mar2021 14:30, outcome "recovered" (2021), described as "little soreness in his arm, where he had the shot". Therapeutic measures were not taken as a result of influenza like illness, diarrhoea, vomiting, vaccination site pain.  Additional Information: Caller/Consumer said that he had a couple of questions and concerns, after he received the first dose of the PFIZER-BIONTECH COVID-19 Vaccine last Wednesday on 31Mar2021, at 2:30pm in the afternoon. At around 6:00pm, he mentioned that his injection arm was sore, where he had the shot and he understands this was typical. He also stated that he did not feel good that night and until a few more days. He asked about a hot and cold flu-like condition, diarrhoea, vomiting. He says his first question was that in a ballpark figure, how long does it take to get pain in the arm, he thought it would be within the first hour. He also asked if the vaccine was a two dose series. He said on his handwritten vaccine card NDC/EXP were not provided. About adverse event treatment: None. About outcome: Left arm soreness went away. About concomitant medications: He said they have not had any other recent vaccinations or started any new medications.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Light-headedness two weeks after second vaccine dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Mar2021 17:00 (Lot number: EL9266) at the age of 66 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, Lot no: EP6955, on 13Feb2021 at 05:00 PM administered in the right arm), administration date: 13Feb2021, when the patient was 66 years old, for Covid-19 Immunisation, reaction(s): "Vertigo", "Loud noise amplified". The following information was reported: DIZZINESS (non-serious) with onset 02Apr2021, outcome "unknown", described as "Light-headedness two weeks after second vaccine dose".  Additional information: There was no Covid prior to vaccination, and no Covid was tested after vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Sinus infection; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 09Mar2021 (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) with onset 28Mar2021, outcome "unknown", described as "Sinus infection". Additional information: She received her 1st dose last 09Mar2021, but then got sinus infection on 28Mar2021 (last Monday). She experienced headache above the eye particularly above the eye, had some yellow discharge as well, and her doctor prescribed her antibiotics (treatment). She had not yet taken them because she is not sure whether this will affect the 2nd vaccine (Unspecified Vaccine) that she is going to have. The 2nd is scheduled on 02Apr2021 by the facility; however, that would be more than 21 days already. So from 09Mar2021, 28 days is 30Mar2021, but then she was scheduled 02Apr2021. She just wanted to know if she should take the antibiotics or if she should wait until after she had 2nd dose. Furthermore, she is asking for how long after she can then start taking it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.