chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Pain, Spinal stenosis, X-ray
Clinical narrative: her spinal stenosis "hit me again"; started "acting up"; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 20Feb2021 (Lot number: EL9267, Expiration Date: May2021) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "spinal stenosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Steroid injections, start date: 2018. The following information was reported: SPINAL STENOSIS (non-serious) with onset 22Feb2021, outcome "not recovered", described as "her spinal stenosis "hit me again"; PAIN (non-serious) with onset 22Feb2021, outcome "unknown", described as "started "acting up"". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of spinal stenosis, pain.  Additional information: The patient was wondering, had spinal stenosis. The patient usually gets steroid shots but the last steroid shot she got was 3 years ago, patient had been fine this whole time until 20Feb2021, her doctor had told to ge t the COVID shot and on 20Feb2021 she got the first shot which was on a Saturday and then Monday her spinal stenosis hit her again, it was the same problem, full time and patient has seen the doctor 2 times since then. Her doctor put her on Hydrocodone and Gabapentin and that didn't do much and then changed it and put her on Oxycodone 3 per day and 2 Lyrica per day which has helped some but he told her make sure to get the second shot on 16Mar.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Vertigo
Clinical narrative: felt like her room was spinning; she felt dizzy; was a little tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Mar2021 14:00 (Lot number: EN6202) at the age of 69 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: VERTIGO (non-serious) with onset 10Mar2021 08:15, outcome "recovered" (10Mar2021), described as "felt like her room was spinning"; DIZZINESS (non-serious) with onset 10Mar2021 08:15, outcome "recovered" (10Mar2021), described as "she felt dizzy"; FATIGUE (non-serious) with onset 10Mar2021 08:15, outcome "recovered" (10Mar2021), described as "was a little tired".  Additional information: Dose of bnt162b2 was administered in upper right arm. Vaccination facility type noted as it was a clinic that was set up for the COVID vaccine. It was done by the hospital, had set up a special clinic to distribute the vaccine. So patient guessed the facility type was a hospital since, they used the building next door. Family medical history relevant to adverse events was noted as none. Prior vaccinations (within 4 weeks) was noted as none. Additional administered vaccines noted as none. It was reported that the patient woke up the morning of 10Mar2021, she felt dizzy that morning and was a little tired, but that was nothing unusual for her. But that morning when she was getting ready to get up she felt dizzy so she sat in bed and she felt like the room was spinning, which that had since stopped (lasted less than a minute). It had subsided. But she did still feel a little bit dizzy. She still felt a little tired but that was not anything abnormal for her. One medication (unspecified) that she was taking did cause her to feel a little tired, that was one of the side effects. When asked if that had improved, stayed the same or worsened patient said that she had not been moving around, she was sitting on the edge of her bed. Patient said she just got up and started walking around and she was having no symptoms. She said maybe it was momentarily, but they were all gone at the time of this report (also reported as now). It was confirmed with patient that at the time of this report all of her previous symptoms were recovered completely at that time. She wanted to know if that was an expected side effect. Adverse event did not require a visit to emergency room or physician office. Investigation assessment noted as no. Relevant tests noted as none.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Entire body vibrated internally; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EM9809), via an unspecified route of administration (administered on the left arm) on 12Feb2021 at 02:45 (at the age of 69-years-old) as dose 1, single for COVID-19 immunisation. Medical history included blood pressure from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient has no allergies to medications, food, or other products. Concomitant medications received within two weeks of vaccination included levothyroxine sodium (L THYROXIN), pantoprazole (PANTOPRAZOL), and unspecified blood pressure medications; all taken for an unknown indication, start and stop date were not reported. On 12Feb2021, the patient experienced entire body vibrated internally. It was reported that, after the first vaccination, it was gone in the morning. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event entire body vibrated internally was resolved on an unknown date in Feb2021 but recurred. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6203) via an unspecified route of administration (administered on the left arm) on 05Mar2021 at 15:45 (at the age of 69-years-old) for COVID-19 immunisation and after the administration, the event (entire body vibrated internally) returned. It was reported that the patient had no idea how long it will last.   No follow-up attempts are needed. No further information is expected.  Amendment:  This follow-up report is being submitted to amend previous information: Deleted Relevant Medical History: None", captured "Blood pressure abnormal" as relevant medical history, added "Vaccine Facility Information", concomitant medication "LEVOTHYROXINE" re-coded as "L THYROXIN" and "PANTOPRAZOL" re-coded as "PANTOPRAZOL [PANTOPRAZOLE]", considered stop date of event to Feb2021 per context (considering reported duration "after the 1st vaccine, it was gone in the morning"), and deleted 2nd dose as co-SD (recurring event).   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Epinephrine, Epinephrine increased, Fatigue, Heart rate
Clinical narrative: metallic taste in the back of my throat; arm got sore a little bit; she felt almost like a pins and needles sensation in her lower legs; little tired; my lower extremities had pins and needles; I felt like a rush of adrenaline; heart was beating a little faster; stress; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (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: DYSGEUSIA (non-serious), outcome "unknown", described as "metallic taste in the back of my throat"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm got sore a little bit"; PARAESTHESIA (non-serious) with onset 09Mar2021, outcome "unknown", described as "my lower extremities had pins and needles"; EPINEPHRINE INCREASED (non-serious) with onset 09Mar2021, outcome "unknown", described as "I felt like a rush of adrenaline"; HEART RATE INCREASED (non-serious) with onset 09Mar2021, outcome "unknown", described as "heart was beating a little faster"; STRESS (non-serious) with onset 09Mar2021, outcome "unknown", described as "stress"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "she felt almost like a pins and needles sensation in her lower legs"; FATIGUE (non-serious), outcome "unknown", described as "little tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient stated that, her arm is a little sore and she was a little tired afterwards but that is it and she says her friends down the street complained of the same thing. But 5 to 10 minutes after she received her vaccine, she was sitting in the chair, and she felt almost like a pins and needles sensation in her lower legs and flushing like a rush of adrenaline. Her heart was then beating fast, but that she chalked up to stress. She also had a metallic taste in her mouth and the back of her throat. The taste only lasted a couple of hours and she knows that certain medications and antibiotics can do that.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Pain in extremity, Paraesthesia, Stress
Clinical narrative: metallic taste in the back of my throat; arm got sore a little bit; she felt almost like a pins and needles sensation in her lower legs; little tired; my lower extremities had pins and needles; I felt like a rush of adrenaline; heart was beating a little faster; stress; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (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: DYSGEUSIA (non-serious), outcome "unknown", described as "metallic taste in the back of my throat"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm got sore a little bit"; PARAESTHESIA (non-serious) with onset 09Mar2021, outcome "unknown", described as "my lower extremities had pins and needles"; EPINEPHRINE INCREASED (non-serious) with onset 09Mar2021, outcome "unknown", described as "I felt like a rush of adrenaline"; HEART RATE INCREASED (non-serious) with onset 09Mar2021, outcome "unknown", described as "heart was beating a little faster"; STRESS (non-serious) with onset 09Mar2021, outcome "unknown", described as "stress"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "she felt almost like a pins and needles sensation in her lower legs"; FATIGUE (non-serious), outcome "unknown", described as "little tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient stated that, her arm is a little sore and she was a little tired afterwards but that is it and she says her friends down the street complained of the same thing. But 5 to 10 minutes after she received her vaccine, she was sitting in the chair, and she felt almost like a pins and needles sensation in her lower legs and flushing like a rush of adrenaline. Her heart was then beating fast, but that she chalked up to stress. She also had a metallic taste in her mouth and the back of her throat. The taste only lasted a couple of hours and she knows that certain medications and antibiotics can do that.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Experienced soreness on the injection site (left arm); 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 left, administration date 08Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Experienced soreness on the injection site (left arm)". Additional information: Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE last 08Mar21 and was scheduled to get the 2nd dose 4 weeks after. Caller was asking if the vaccine will still be in the process for approval. She mentioned that she knows it was given an Emergency Use authorization. She was also asking if it was okay that she was scheduled for 4 weeks after the first dose. She read from papers that it is supposed to be 3 weeks. She was scheduled to have her second dose on 05Apr2021.  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: Asthenia, Dehydration, Illness, Malaise, Nausea
Clinical narrative: very weak; generally unwell; her arm finally quit hurting today from her injection; nausea; dehydrated; throwing up; sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 12:15 (Lot number: EN6198) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart condition" (unspecified if ongoing); "Blood pressure high", start date: 2000 (unspecified if ongoing), notes: She says that the high blood pressure was diagnosed 15-20 years ago, let's say in 2000,. The patient took concomitant medications. The following information was reported: VOMITING (non-serious) with onset 05Mar2021, outcome "unknown", described as "throwing up"; ILLNESS (non-serious) with onset 05Mar2021, outcome "unknown", described as "sick"; ASTHENIA (non-serious), outcome "unknown", described as "very weak"; MALAISE (non-serious), outcome "unknown", described as "generally unwell"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm finally quit hurting today from her injection"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; DEHYDRATION (non-serious), outcome "unknown", described as "dehydrated". Therapeutic measures were not taken as a result of vomiting, malaise, nausea.  Additional information: She says she had her first shot at noon on Friday, and it is now Wednesday and she has been sick and throwing up and was very weak. She says she has been generally unwell since it all happened. She says the first vaccine is in her system and it is almost time to get her second dose which is scheduled for the 27Mar2021. She says that her arm finally quit hurting today from her injection. She says that her feeling sick and throwing up started the day she got her injection, two hours after. She says she did no treatment for throwing up, she just threw up one time that day, then a couple days she had nausea and then she threw up again yesterday twice. She says that she had thought it would have gone away by yesterday. Patient have not had any other recent vaccinations or started any new medications. She says she has been on some medications for years but has started nothing new. No further information provided about her medications. She cannot take unspecified steroids, and that she has a heart condition, high blood pressure. Caller says she doesn't want to take the vaccine again if this might happen again or is just the tip of the iceberg, as was beginning to get dehydrated, and she wonder if this immunization was going to work at all without her second shot, but everyone she asks, no one knows anything. Reporter seriousness for sickness, throwing up, weakness and arm was hurting were unspecified.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: very weak; generally unwell; her arm finally quit hurting today from her injection; nausea; dehydrated; throwing up; sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 12:15 (Lot number: EN6198) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart condition" (unspecified if ongoing); "Blood pressure high", start date: 2000 (unspecified if ongoing), notes: She says that the high blood pressure was diagnosed 15-20 years ago, let's say in 2000,. The patient took concomitant medications. The following information was reported: VOMITING (non-serious) with onset 05Mar2021, outcome "unknown", described as "throwing up"; ILLNESS (non-serious) with onset 05Mar2021, outcome "unknown", described as "sick"; ASTHENIA (non-serious), outcome "unknown", described as "very weak"; MALAISE (non-serious), outcome "unknown", described as "generally unwell"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm finally quit hurting today from her injection"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; DEHYDRATION (non-serious), outcome "unknown", described as "dehydrated". Therapeutic measures were not taken as a result of vomiting, malaise, nausea.  Additional information: She says she had her first shot at noon on Friday, and it is now Wednesday and she has been sick and throwing up and was very weak. She says she has been generally unwell since it all happened. She says the first vaccine is in her system and it is almost time to get her second dose which is scheduled for the 27Mar2021. She says that her arm finally quit hurting today from her injection. She says that her feeling sick and throwing up started the day she got her injection, two hours after. She says she did no treatment for throwing up, she just threw up one time that day, then a couple days she had nausea and then she threw up again yesterday twice. She says that she had thought it would have gone away by yesterday. Patient have not had any other recent vaccinations or started any new medications. She says she has been on some medications for years but has started nothing new. No further information provided about her medications. She cannot take unspecified steroids, and that she has a heart condition, high blood pressure. Caller says she doesn't want to take the vaccine again if this might happen again or is just the tip of the iceberg, as was beginning to get dehydrated, and she wonder if this immunization was going to work at all without her second shot, but everyone she asks, no one knows anything. Reporter seriousness for sickness, throwing up, weakness and arm was hurting were unspecified.   No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: red circle on her left arm at the injection site/Pinkish red and warm to touch at injection site/red circle around injection site; Pinkish red and warm to touch at injection site; Soreness at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 (Lot number: EN6205) 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. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization. The following information was reported VACCINATION SITE ERYTHEMA (non-serious) with onset 09Mar2021, outcome not recovered; VACCINATION SITE WARMTH (non-serious) with onset 09Mar2021, outcome not recovered; VACCINATION SITE PAIN (non-serious) with onset 09Mar2021, outcome not recovered.  The patient stated that on Monday 08Mar2021 she received her second vaccine and she noticed the next day she developed a red circle on the left arm where she got her injection and she continued to say she did not have that problem the first time with her vaccine. The patient did have some redness and soreness at the injection site. She stated the red circle area started about the size of nickel and was probably quarter size at the time of reporting and was red but not bright red, it was more of a pinkish red and it was not hot to touch but more like slightly warm to the touch. Patient remarked that it may not be spreading but actually spreading out and dissipating.   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: body aches starting 6 hours after injection lasting 8 hours; headache within 15 minutes of injection; vaccine administered on left leg; Sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in leg left, administration date 07Feb2021 10:30 (Batch/Lot number: unknown) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing); "Hypertension" (unspecified if ongoing), notes: HTN; "Lung sarcoid" (unspecified if ongoing), notes: Lung Sarcoidosis. Concomitant medication(s) included: HCTZ; FAMOTIDINE; VITAMIN D [VITAMIN D NOS]. Past drug history included: Atropine, reaction(s): "Drug allergy"; Ibuprofen, reaction(s): "Drug allergy". The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 07Feb2021 10:30, outcome "unknown", described as "vaccine administered on left leg"; HEADACHE (non-serious) with onset 07Feb2021 10:45, outcome "recovered" (2021), described as "headache within 15 minutes of injection"; PAIN (non-serious) with onset 07Feb2021 16:30, outcome "recovered" (08Feb2021 00:30), described as "body aches starting 6 hours after injection lasting 8 hours"; PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "Sore arm". Therapeutic measures were not taken as a result of product administered at inappropriate site, headache, pain, pain in extremity.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: his arm feels like it has a knife in it; when he tries to pick up something, move his arm, or do something he gets a sharp, sharp pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, other case identifier(s) US-PFIZER INC-2021273137.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 31Jan2021 (Lot number: EN5318) at the age of 69 years as 2nd dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.   Vaccination history included Bnt162b2 (First shot: COVID vaccine, Drug Batch Number: EK4176, Drug dosage text: unknown dose; upper right arm, Drug start date: 03Jan2021), administration date: 03Jan2021, when the patient was 69 years old, for COVID-19 Immunization.  The following information was reported PAIN IN EXTREMITY (non-serious) with onset 04Jan2021, outcome not recovered; PAIN (non-serious) with onset 04Jan2021, outcome not recovered. Therapeutic measures were taken as a result of pain in extremity, pain.  Patient did not receive any other vaccines with in four weeks   No follow-up attempts are possible. No further information is expected. Linked Report(s) US-PFIZER INC-2021267956 similar report from same reporter.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Neck pain
Clinical narrative: Sore Muscles (around injection site and neck); Sore Muscles (around injection site and neck); Mild Headache; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 13:15 (Lot number: EL 3247) at the age of 24 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic Migraines (unfortunately, with similar symptoms" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: Avocados" (unspecified if ongoing). Concomitant medication(s) included: AMITRIPTYLINE; PROPRANOLOL; CAMBIA. The following information was reported: MYALGIA (non-serious), NECK PAIN (non-serious) all with onset 10Mar2021 15:00, outcome "recovering" and all described as "Sore Muscles (around injection site and neck)"; HEADACHE (non-serious) with onset 10Mar2021 15:00, outcome "recovering", described as "Mild Headache"; FATIGUE (non-serious) with onset 10Mar2021 15:00, outcome "recovering", described as "Fatigue". Therapeutic measures were not taken as a result of myalgia, neck pain, headache, fatigue.  Additional information: About 2-3 hours after vaccination (10Mar2021), patient noticed the symptoms. The patient did not receive any other vaccine in four weeks. The patient did not have covid prior to vaccination and was not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Restlessness
Clinical narrative: tired; restless; out of sorts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a program (159558). The reporter is the patient.  A female patient 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 FATIGUE (non-serious), outcome unknown; RESTLESSNESS (non-serious), outcome unknown; MALAISE (non-serious), outcome unknown.  The vaccine more than 21 days after the first dose. She got her first dose of the vaccine last 09Mar2021. The facility was scheduled her second dose on 02Apr2021.     No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Hypokinesia, Neck pain
Clinical narrative: could not move his neck stating the area was the size of a quarter; neck, pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 81 year-old male patient received bnt162b2 (BNT162B2), administration date 07Mar2021 (Lot number: EN6203) at the age of 81 years as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HYPOKINESIA (non-serious) with onset 08Mar2021, outcome "not recovered", described as "could not move his neck stating the area was the size of a quarter"; NECK PAIN (non-serious) with onset 08Mar2021, outcome "not recovered", described as "neck, pain". Therapeutic measures were taken as a result of hypokinesia, neck pain.  Follow-up (11Mar2021): This is a follow-up spontaneous report from two contactable consumers. A contactable consumer (wife) and a contactable 81-year-old consumer (patient) reported information included.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Felt a little achy took an Advil and feel fine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Mar2021 (Lot number: Unknown) as single dose and (Batch/Lot number: unknown) for covid-19 immunisation. Relevant medical history included: "UNKNOWN" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Felt a little achy took an Advil and feel fine". Therapeutic measures were taken as a result of pain. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Caller stated that her arm was sore in the muscle; Caller stated that her arm was sore in the muscle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm (Batch/Lot number: unknown) as dose 1 single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Caller stated that her arm was sore in the muscle".  Additional information: Caller stated that when she went to receive the first dose of the Pfizer Covid 19 vaccine, the nurse was looking at the back of her arm and the caller thinks the vaccine was given more in the triceps instead of the deltoid muscle. Caller wanted to know if this is less effective and should she get a titer. Caller wanted to know if she got some efficacy after the first dose and would get the 95% after the second dose.Patient Age: 61.  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: Vaccination site macule, Vaccination site pain, Vaccination site pruritus
Clinical narrative: itching at my injection site and noticed a red dot  that is 2 1/2 inches in diameter; itching at my injection site and noticed a red dot  that is 2 1/2 inches in diameter; it has slight burn; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Mar2021 (Lot number: EN6502, EN6205) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EL9267 or EL9269, Anatomical Location: Right arm), administration date: 13Feb2021, when the patient was 71 years old, for COVID-19 immunisation, reaction(s): "sore arm"; Flu vaccine, reaction(s): "sore arm". The following information was reported: VACCINATION SITE MACULE (non-serious) with onset 09Mar2021, outcome "not recovered", VACCINATION SITE PRURITUS (non-serious) with onset Mar2021, outcome "unknown" and all described as "itching at my injection site and noticed a red dot  that is 2 1/2 inches in diameter"; VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "it has slight burn". Therapeutic measures were taken as a result of vaccination site macule, vaccination site pruritus, vaccination site pain.  Additional information: The patient stated that the lot number for dose 2 listed on card was EN6502, but she received an email from the health Department that listed the Lot number as EN6205. She reported she received the vaccine between 15:30 and 16:00. The patient reported that she received the second dose of vaccine on Saturday, 06Mar2021. She stated that Sunday 07Mar2021 and Monday 08Mar2021 she was fine she had hardly any pain in her arm or nothing. On the afternoon of Tuesday 09Mar2021, she noticed a big red spot just below and to the right of injection site. She reported that it measures 2.5 inches in diameter, that it is not painful, it is sometimes itchy, and that it has slight burn. She stated that on a scale of one to ten (10 being the worst), she would rate the burning sensation at maybe a 2. The patient was treating the red spot with cold compresses. Additional administered vaccines were none. AE(s) did not require a visit to emergency room nor physician office visit. Family medical history relevant to ae(s) was no.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Vertigo
Clinical narrative: vertigo; slight headache; minor chills; sore arm; tiredness; 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 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 16:00 (Lot number: EN6202) at the age of 68 years as dose 2, single for covid-19 immunisation. Family history included: "vertigo" (unspecified if ongoing), notes: mother had vertigo in her 70s due to Menieres syndrome of the inner ear; "Menieres syndrome" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VERTIGO (non-serious) with onset 04Mar2021, outcome "recovering", described as "vertigo"; PAIN IN EXTREMITY (non-serious) with onset 26Feb2021, outcome "recovered" (27Feb2021), described as "sore arm"; FATIGUE (non-serious) with onset 26Feb2021, outcome "recovered" (09Mar2021), described as "tiredness"; CHILLS (non-serious) with onset 27Feb2021, outcome "recovered" (28Feb2021), described as "minor chills"; HEADACHE (non-serious) with onset 28Feb2021, outcome "recovered" (01Mar2021), described as "slight headache".  Additional information: Patient mother had vertigo in her 70s due to Meniere's syndrome of the inner ear. The patient was asking for her vertigo because she mentioned that 6 days after the second dose it was still there. Then she started to have episodes of vertigo on day six and that worried her. It did happen many times during the day whenever she would turn her head or get up or sit down. She has had the vertigo every day since from 04Mar2021 to today although it seems to be getting less. Mentioned she was very healthy and did not take any medications. The patient did not have any prior vaccinations (within 4 weeks). There was no relevant test. There were no additional vaccines administered on same date of the Pfizer suspect.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Sore arm at injection site and very fatigued; Sore arm at injection site and very fatigued; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (pregnant) received bnt162b2 (BNT162B2, Solution for injection), administered in arm left, administration date 11Mar2021 09:00 (Batch/Lot number: unknown) at the age of 32 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Date of last menstrual period: 24Jul2020. The patient was 32 weeks pregnant at the time of exposure to bnt162b2; 31 weeks pregnant to anti-d immunoglobulin. The patient was 33 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 21Apr2021. Concomitant medication(s) included: RHOGAM, administration date 04Mar2021; SYNTHROID. Past drug history included: Benadryl, reaction(s): "known allergies : Benadryl", notes: known allergies : Benadryl. Vaccination history included: Rhogam (other vaccine 4weeks : Rhogam), administration date: 04Mar2021. The following information was reported: VACCINATION SITE PAIN (non-serious), FATIGUE (non-serious) all with onset 12Mar2021 07:30, outcome "not recovered" and all described as "Sore arm at iprenatalsnjection site and very fatigued". Therapeutic measures were not taken as a result of vaccination site pain, fatigue. Additional information: The patient received other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination synthroid .125, prenatals. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts completed. No further information expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: He now has swelling in his arm, in the injection site.;  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 27 year-old male patient received bnt162b2 (BNT162B2), administration date 11Mar2021 14:30 (Batch/Lot number: unknown) at the age of 27 years as dose number unknown,0.3ml 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) with onset 12Mar2021, outcome "unknown", described as "He now has swelling in his arm, in the injection site.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Panic attack
Clinical narrative: a bad panic attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 54 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing); "immune issues" (unspecified if ongoing), notes: immune issues; "brain surgery" (unspecified if ongoing), notes: brain surgery; "bad anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PANIC ATTACK (non-serious), outcome "unknown", described as "a bad panic attack". The event "a bad panic attack" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of panic attack.  Additional information: The reporter's contact information available to you or a sub-contracted party was provided. The patient identifiers were not provided, it is unknown if the reporter had a specific patient in mind. The reporter had a family member who got their 1st dose of the Covid vaccine and they had anaphylactic shock which later was determined by the emergency room that it was a panic attack. Her family member had tightness in the chest and difficulty breathing. Now they had a hard time getting their second dose because of what happened. She stated that this family had a history of brain surgery and COPD so it's important that they get their second dose since the emergency room declared it a panic attack.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Product administered at inappropriate site
Clinical narrative: was given above the deltoid muscle  at the very top of his shoulder; pain and redness in the area following the injection; pain and redness in the area following the injection; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2), administered in arm, administration date 10Mar2021 (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious), outcome "unknown", described as "was given above the deltoid muscle  at the very top of his shoulder"; INJECTION SITE PAIN (non-serious), INJECTION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "pain and redness in the area following the injection". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Pain in extremity, Vaccination site movement impairment
Clinical narrative: Immediate hot flashes after both shots; painful as went into arm; pain was so bad the next day i couldn't even lift my arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Feb2021 08:15 (Lot number: EL 9266) at the age of 27 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "moderate-severe asthma" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: PREVIFEM; ARNUITY ELLIPTA. Past drug history included: Amoxicillin, reaction(s): "Allergies"; Azithromycin, reaction(s): "Allergies"; Benzyol peroxide, reaction(s): "Allergies", notes: Benzyol peroxide: Allergies; Sudafed for Heart palpitations; Ceftin, reaction(s): "Allergies". The following information was reported: HOT FLUSH (non-serious), outcome "recovering", described as "Immediate hot flashes after both shots"; PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "painful as went into arm"; VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious), outcome "recovering", described as "pain was so bad the next day i couldn't even lift my arm". Therapeutic measures were not taken as a result of hot flush, pain in extremity, vaccination site movement impairment.  Additional information : Dose 1: 1st shot was immediately painful as went into arm, pain was so bad the next day that patient couldn't even lift her arm. Immediate hot flashes after both shots. It was unknown if patient had Covid prior vaccination. Patient had not been Covid tested post vaccination  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: 13 days after the vaccine patient had a swollen lymph node in my left side of my collar bone; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Feb2021 12:15 (Lot number: EN6198) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression disorder" (unspecified if ongoing); "allergies" (unspecified if ongoing); "Allergic to trees" (unspecified if ongoing); "Allergic to pollen" (unspecified if ongoing); "Allergic to dogs" (unspecified if ongoing); "Allergic to walnut" (unspecified if ongoing); "Allergic to cats" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 11Mar2021 20:00, outcome "not recovered", described as "13 days after the vaccine patient had a swollen lymph node in my left side of my collar bone". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional Information: The patient did not receive any other vaccination in the last four weeks. It was reported that the patient never had COVID prior vaccination and was not tested for COVID post vaccination. The other medications in two weeks was Zyrtec   No follow-up attempts are possible. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: insomnia/has not been able to sleep past an hour or two at a time since 12Feb2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 87 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Feb2021 (Batch/Lot number: unknown) at the age of 87 years as dose number unknown single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: INSOMNIA (non-serious) with onset 13Feb2021, outcome "not recovered", described as "insomnia/has not been able to sleep past an hour or two at a time since 12Feb2021".  Additional information: Caller was caring for 87 year old mother. Her mother received the Pfizer COVID-19 vaccine on 12Feb2021. She stated shortly after her mom developed insomnia and has not been able to sleep past an hour or two at a time since 12Feb2021. Caller wanted to know if this was a side effect of the vaccine and long can she expect it to last. Time of Onset (24 hour clock): Began night of the 13Feb2021 at bedtime.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.