chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain
Clinical narrative: ribcage to feel sore, as if it was bruised; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (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), for Covid-19 immunization. The following information was reported: MUSCULOSKELETAL CHEST PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "ribcage to feel sore, as if it was bruised".  Additional information: Caller received the second dose of the Pfizer-BioNTech COVID-19 Vaccine last Tuesday, 06Apr2021. Caller reported that by the following Monday, she experienced her "ribcage to feel sore, as if it was bruised". She said this "came and went for 24 hours".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dizziness postural, Fatigue, Vertigo
Clinical narrative: vertigo and dizziness when he stands up and lie down; tired; felt really dizzy; vertigo and dizziness when he stands up and lie down; 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 54 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 07Apr2021 (Lot number: ER8727) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Prostate cancer", start date: 2017 (ongoing), notes: All under control, diagnosed in late 2017; "Anxiety" (ongoing). Concomitant medication(s) included: VENLAFAXINE HCL taken for anxiety, start date: 2017 (ongoing); FINASTERIDE taken for prostate cancer, start date: 2017 (ongoing); TAMSULOSIN HCL taken for prostate cancer, start date: 2017 (ongoing); VITAMIN D SUPPORT taken for supplementation therapy, start date: 2017 (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Lot number: EN6025), administration date: 17Mar2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 10Apr2021, outcome "recovering", described as "felt really dizzy"; VERTIGO (non-serious) with onset 10Apr2021, outcome "unknown", DIZZINESS POSTURAL (non-serious), outcome "unknown" and all described as "vertigo and dizziness when he stands up and lie down"; FATIGUE (non-serious), outcome "unknown", described as "tired".  Additional information: The patient did not have any family medical history relevant to adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No additional vaccines were administered on same date of the Pfizer Suspect. The patient received second dose of Pfizer COVID-19 vaccine on Wednesday, 07Apr2021. The patient had vertigo, and dizziness when he stands up and lie down. The onset time of adverse events was 22:30-23:00 pm. The patient stated that late evening on Saturday, 10Apr2021 at about 23:00 pm he was laying down to go to bed, felt really dizzy. He thought maybe he was just tired and laid there as long as he could and about "230/0300" he got up to go to the bathroom and felt really dizzy at that time. This had stayed with him since then. He experienced it more when he was sitting down and getting up and definitely once he was laying down and then stands up. He guesses they were more like vertigo symptoms. He thought it has gotten better but he still had the symptoms. He didn't know if this makes a difference but symptoms were more impactful when he lays down on his right side. The adverse events did not require a visit to Emergency Room or Physician Office. He called PA and got Meclizine prescribed and some exercises to do for vertigo. The patient wanted to know if there were others who reported having the same AE and if anyone else has experienced this event, how long it would last.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Malaise, Vomiting
Clinical narrative: had all the same symptoms she did and "got really bad with her for a couple of days" after her first dose; headache; vomiting; diarrhoea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient in her 70's 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: MALAISE (non-serious), outcome "unknown", described as "had all the same symptoms she did and "got really bad with her for a couple of days" after her first dose"; HEADACHE (non-serious), outcome "unknown", described as "headache"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhoea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Productive cough, Rhinalgia
Clinical narrative: feeling unwell; mucus; phlegm; I feel really tired, I don't want to get up; My forehead and nose also hurt; My forehead and nose also hurt; 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 36 year-old female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Batch/Lot number: unknown) as dose 1,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 09Apr2021, outcome "unknown", described as "feeling unwell"; SECRETION DISCHARGE (non-serious) with onset 09Apr2021, outcome "unknown", described as "mucus"; PRODUCTIVE COUGH (non-serious) with onset 09Apr2021, outcome "unknown", described as "phlegm"; FATIGUE (non-serious) with onset 09Apr2021, outcome "unknown", described as "I feel really tired, I don't want to get up"; HEADACHE (non-serious), RHINALGIA (non-serious) all with onset 09Apr2021, outcome "unknown" and all described as "My forehead and nose also hurt".  Additional information: Patient received the first dose of the Pfizer Covid 19 vaccine on 7Apr. Since 9Apr she have been feeling unwell, she have mucus, phlegm and she feel really tired, she don't want to get up. Her forehead and nose also hurt. Events was reported as non serious by the reporter.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Secretion discharge
Clinical narrative: feeling unwell; mucus; phlegm; I feel really tired, I don't want to get up; My forehead and nose also hurt; My forehead and nose also hurt; 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 36 year-old female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Batch/Lot number: unknown) as dose 1,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 09Apr2021, outcome "unknown", described as "feeling unwell"; SECRETION DISCHARGE (non-serious) with onset 09Apr2021, outcome "unknown", described as "mucus"; PRODUCTIVE COUGH (non-serious) with onset 09Apr2021, outcome "unknown", described as "phlegm"; FATIGUE (non-serious) with onset 09Apr2021, outcome "unknown", described as "I feel really tired, I don't want to get up"; HEADACHE (non-serious), RHINALGIA (non-serious) all with onset 09Apr2021, outcome "unknown" and all described as "My forehead and nose also hurt".  Additional information: Patient received the first dose of the Pfizer Covid 19 vaccine on 7Apr. Since 9Apr she have been feeling unwell, she have mucus, phlegm and she feel really tired, she don't want to get up. Her forehead and nose also hurt. Events was reported as non serious by the reporter.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: Her hands, feet became swollen; Her ankles became swollen; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer unknown), for COVID-19 Immunization.  The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Her hands, feet became swollen"; JOINT SWELLING (non-serious), outcome "unknown", described as "Her ankles became swollen". Additional Information: Patient wants to know if these side effects have been reported with the vaccine, and if she needs to see her doctor. Responded from the attached SRD, "CONS-what are the risks of the vaccine" also referred the patient to HCP for more guidance.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Mar2021 08:00 (Batch/Lot number: unknown) at the age of 20 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "injection site pain". Therapeutic measures were taken as a result of vaccination site pain.  Additional information: It was reported that there was no other vaccine administered in four weeks from vaccination. The treatment was taken as some ibuprofen. patient was not tested for Covid post vaccination. Facility type Vaccine: Hospital.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Oral mucosal blistering, Renal pain, Tongue discomfort
Clinical narrative: This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). A female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 30Mar2021 (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), for COVID-19 immunisation. The following information was reported: ORAL MUCOSAL BLISTERING (non-serious) with onset Apr2021, outcome "not recovered", described as "blisters a week later inside and outside of her mouth"; TONGUE DISCOMFORT (non-serious) with onset Apr2021, outcome "not recovered", described as "Her tongue feels raw, like it was burned"; BACK PAIN (non-serious), RENAL PAIN (non-serious) all with onset Apr2021, outcome "not recovered" and all described as "And she has pain in her back around her kidneys". Additional information: she broke out in blisters a week later inside and outside of her mouth. Her tongue feels raw, like it was burned. And she had pain in her back around her kidneys on both sides. She thought it was going away, but came back even worse. 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 pain, Nausea, Pain, SARS-CoV-1 test positive
Clinical narrative: Sore injection site; Nausea; Bodyaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Mar2021 15:45 (Lot number: ER2613) 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 (Route of administration: intramuscular, left arm, Batch/lot number: ENG201, Severe Bodyaches, Headache, Sore injection, Onset date 20Feb2021), administration date: 19Feb2021, when the patient was 43 years old, for Covid-19 Immunisation. The following information was reported: INJECTION SITE PAIN (non-serious) with onset 19Mar2021, outcome "recovered" (2021), described as "Sore injection site"; NAUSEA (non-serious) with onset 19Mar2021, outcome "recovered" (2021), described as "Nausea"; PAIN (non-serious) with onset 19Mar2021, outcome "recovered" (2021), described as "Bodyaches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of injection site pain, nausea, pain.  Additional information: The patient did not taken prior Vaccinations.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Insomnia, Pain assessment, Pain in extremity
Clinical narrative: armpit and under arm from my armpit heading to my elbow, but not all the way to my elbow, was in severe pain; armpit and under arm from my armpit heading to my elbow, but not all the way to my elbow, was in severe pain; discomfort was so bad that i never fell asleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 14:15 (Batch/Lot number: unknown) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Known allergies: other pain killers" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Past drug history included: Morphine for for kidney stone, reaction(s): "Nausea", notes: I have a very bad reaction to morphine (received once for kidney stones),codeine and other pain killers. Bad, nausea, dizziness, vomiting, falling; Morphine for for kidney stone, reaction(s): "Dizziness"; Morphine for for kidney stone, reaction(s): "Vomiting"; Morphine for for kidney stone, reaction(s): "Falling"; Codeine, reaction(s): "Nausea", notes: I have a very bad reaction to morphine (received once for kidney stones),codeine and other pain killers. Bad, nausea, dizziness, vomiting, falling; Codeine, reaction(s): "Dizziness"; Codeine, reaction(s): "Vomiting"; Codeine, reaction(s): "Falling". Vaccination history included: Bnt162b2 (Product=COVID 19,, Lot unknown=False,, Dose number=1), when the patient was 55 years old, for COVID-19 immunisation. The following information was reported: AXILLARY PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 23Mar2021 09:00, outcome "recovered" (2021) and all described as "armpit and under arm from my armpit heading to my elbow, but not all the way to my elbow, was in severe pain"; INSOMNIA (non-serious) with onset 23Mar2021 09:00, outcome "recovered" (2021), described as "discomfort was so bad that i never fell asleep". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of axillary pain, pain in extremity, insomnia.  Additional Information: There was no any other vaccine in four weeks.The morning after the day I received my 2nd dose, upon waking up. I have a high tolerance for pain. The pain level was HIGH. This lasted for 5 nights and on the 6th day subsided. The pain and discomfort was so bad that I never fell asleep until completely exhausted at - 5am or 6am. I was literally up all night. The only relief was from holding frozen bags of vegetables under my armpit. This was only felt on the left side - the side that the vaccine was given to me. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history included COVID-19 (unspecified if ongoing). The patient's concomitant medications not reported. The patient developed illness (she and her husband both sick after the vaccine) and malaise (felt lousy), with outcome of unknown. Additional information: Reporter stated her friend (patient) had COVID-19; she got the vaccine and she was fine other than feeling lousy. Patient and her husband both were sick after the vaccination. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s) : US-PFIZER INC-2021421209 same reporter/product/event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to toxic agent
Clinical narrative: She thought she had a reaction to the vaccine, but it was actually poison ivy; 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 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: EXPOSURE TO TOXIC AGENT (non-serious), outcome "unknown", described as "She thought she had a reaction to the vaccine, but it was actually poison ivy".  Additional information: She got prescribed prednisone. Her doctor told her she shouldn't get a vaccine while taking that medication. She thought she had a reaction to the vaccine, but it was actually poison ivy. she wants to reschedule her second dose for another time. She didn't have info for vaccination site  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Pounding Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 (Batch/Lot number: unknown) at the age of 16 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Glucose tolerance impaired" (ongoing), notes: Verbatim: Pre-diabetic, Diagnosed about 6 years ago.; "Overweight" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose, Covid Vaccine, Batch/Lot number:ER8732, Dose; Left Arm), administration date: 23Mar2021, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 13Apr2021, outcome "not recovered", described as "Pounding Headache".  Additional information: Caller states his 16 yr old took his second shot yesterday and he has a pounding headache. States he wants to know what his son can take for his headache. States he sees it listed as a side effect but doesn't see anything about what he can or can't take. Doesn't know if he can give him aspirin or what.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Eye infection, Glycosylated haemoglobin
Clinical narrative: he has an infection in her eye; has a really bad eye infection, like conjunctivitis; 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. Other Case identifier(s): US-PFIZER INC-2021404824.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METFORMIN HYDROCHLORIDE taken for glucose tolerance impaired. The following information was reported: EYE INFECTION (non-serious) with onset 10Apr2021, outcome "not recovered", described as "he has an infection in her eye"; CONJUNCTIVITIS (non-serious) with onset 10Apr2021, outcome "unknown", described as "has a really bad eye infection, like conjunctivitis". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received the vaccine between 17:30 and 17:45. The patient did not received any prior vaccines within 4 weeks. The patient received the first dose of Pfizer COVID19 vaccine on 25Mar2021. She was scheduled to take second dose on 15Apr2021. The eye infection started two weeks and two days after her fist vaccine, 10Apr2021. She woke up with the eye infection. Honestly, when she woke up with it she didn't initially believe it was another case of conjunctivitis. She had a really bad eye infection, like conjunctivitis. She has had it before. She thought she slept with her eye open. Her eye was dry. She tried to ignore it to see if it would get better. It was really bad. She needs to get treated with antibiotic drops. The patient was asking if it was ok to take the second dose while her eye was in such pain and/or she was taking antibiotics. The patient was asking if she can take the second vaccine along with the antibiotics or should she wait before getting the vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Just a sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 25 year-old female patient received bnt162b2 (BNT162B2), administration date 14Apr2021 (Batch/Lot number: unknown) at the age of 25 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 24Mar2021, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 14Apr2021, outcome "unknown", described as "Just a sore arm".  Additional Information: Reporter stated via text message that her daughter was fine went she went to bed last night. Just a sore arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Furuncle, Pain
Clinical narrative: Stated that it looks like a lump on her armpit when she lifts her arm.; it was painful and anything that it touches that it hurts; something that appeared as a boil; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Apr2021 (Lot number: EP533) at the age of 30 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: AXILLARY MASS (non-serious) with onset 10Apr2021, outcome "not recovered", described as "Stated that it looks like a lump on her armpit when she lifts her arm."; PAIN (non-serious) with onset 10Apr2021, outcome "not recovered", described as "it was painful and anything that it touches that it hurts"; FURUNCLE (non-serious) with onset 10Apr2021, outcome "unknown", described as "something that appeared as a boil". The events "stated that it looks like a lump on her armpit when she lifts her arm." and "it was painful and anything that it touches that it hurts" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of axillary mass, pain.  Additional information: she had the Pfizer vaccine second dose on 09 Apr and stated that she was going to go to the doctor because it was painful and anything that it touches that it hurts. Stated that it looks like a lump on her armpit when she lifts her arm and it has not gone away. Clarified the something that appeared as a boil. Wanted to know when it is going away and what should she do.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dental implantation, Infection
Clinical narrative: dentist today and had an implant. They gave him Amoxicillin for the infection; gave him Amoxicillin for the 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 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: DENTAL IMPLANTATION (non-serious), outcome "unknown", described as "dentist today and had an implant. They gave him Amoxicillin for the infection"; INFECTION (non-serious), outcome "unknown", described as "gave him Amoxicillin for the infection.". Therapeutic measures were taken as a result of dental implantation, infection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: extremely sore arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Mar2021 (Lot number: Unknown) as dose 1, single and administration date 31Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (ongoing), notes: Verbatim: High Blood Pressure; "Severe Joint Damage" (ongoing), notes: Verbatim: Severe Joint Damage. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "extremely sore arm".  Additional information: Covid Vaccine: extremely sore arm, Related, Reporter states she was driving and some details were unable to be obtained. There was a lot of road noise and/or muffled sound that made some things difficult to hear. Call handler did ask caller to repeat or clarify if it was thought to not have been heard.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain
Clinical narrative: chills/but she got chills; injection site pain of the left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 10:45 (Lot number: EW0151, Expiration Date: 11Apr2021) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TURMERIC + taken for phytotherapy (ongoing); ZINC taken for phytotherapy (ongoing); OMEGAN taken for phytotherapy (ongoing). The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills/but she got chills"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site pain of the left arm".  Additional information: NDC number of Pfizer-BioNTech COVID-19 Vaccine was unknown. Reason for no lot number was other she can't really read it because they put a sticker overlapping the handwritten Lot number on the CDC vaccine record card but she thinks it is EN6207. She got her first dose of Pfizer-BioNTech COVID-19 Vaccine on 18Mar2021 and had some side effects after that which were manageable and went away. Onset time unknown other than closer to the night time. Further described as she did not get fever; but she got chills and injection site pain of the left arm; the injection site did not get red or anything. Her menstrual cycle and symptoms were not affected by the first dose. she is a very healthy individual. No any vaccines administered on same date with the Pfizer vaccine considered as suspect. AE(s) not require Emergency Room and Physician Office. Patient was not hospitalized. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No any relevant Tests.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: has cold symptoms since Sunday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Lot number: Not Provided) 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: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "has cold symptoms since Sunday".  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Pain in arm; Tiredness and fatigue; 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 57 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 22Mar2021 15:00 (Lot number: ER8727) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergy to tegretol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Fluorouracil for skin cancer procedure.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Pain in arm"; FATIGUE (non-serious), outcome "recovering", described as "Tiredness and fatigue".  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm hurt bad, like really achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Lot number: ER2613) at the age of 53 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Mar2021, outcome "recovered" (22Mar2021), described as "Arm hurt bad, like really achy". Therapeutic measures were taken as a result of pain in extremity.  Additional information: No Additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient clarifies that with the first one, her arm hurt bad, like really achy. States she never checked her lymph nodes then. States in her mind, they said her arm may hurt that day and she took Tylenol and it did subside. Treatment included slept with heat on her back and took Tylenol. No Physician Office or Emergency Room visit.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nasopharyngitis
Clinical narrative: 1st vaccine and then became ill; it was a cold and not allergies; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "1st vaccine and then became ill"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "it was a cold and not allergies".  Additional information: She wanted to know what she should she do about her 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 15:00 (Lot number: EN6202) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Rare Tuna" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "high cholesteryl" (unspecified if ongoing); "High trigs" (unspecified if ongoing); "Hiatal Hernia" (unspecified if ongoing). Concomitant medication(s) included: NIASPAN; NORVASC; LISINOPRIL; VASCEPA; CRESTOR; NE [TOCOPHEROL]. The following information was reported: TINNITUS (non-serious) with onset 04Mar2021 03:00, outcome "not recovered", described as "Tinnitus". The event "tinnitus" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus.  Additional info: Patient stated, I did receive my second injection on 24Mar, and it got a bit worse. I saw ENT. I did take 12 days of prednisone which helped, but once I stopped the ringing returned. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Patient was not diagnosed with COVID-19, Prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: had a sore arm for about 48 hours; fuzziness that started which eventually went into fatigue; fuzziness that started which eventually went into fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 12:00 (Lot number: EN6199) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EN6201, Vaccine administration time: 14:00 pm, Anatomical location: Right arm), administration date: 14Feb2021, when the patient was 73 years old, for COVID-19 immunization, reaction(s): "sore arm", "heavy chills". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Mar2021, outcome "recovered" (10Mar2021), described as "had a sore arm for about 48 hours"; FEELING ABNORMAL (non-serious) with onset 08Mar2021, outcome "recovered" (Mar2021), FATIGUE (non-serious) with onset Mar2021, outcome "not recovered" and all described as "fuzziness that started which eventually went into fatigue". Therapeutic measures were not taken as a result of pain in extremity, feeling abnormal, fatigue.  Additional information: The patient did not have any family medical history relevant to the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the second dose on 08Mar2021 and had a sore arm for about 48 hours and fuzziness that started which eventually went into fatigue which he thought was something normal but it got heavier to the point that to make coffee in morning it was tough and to do anything during day he could only sit and stated taking 2 to 3 naps a day for over a hour a piece. Fuzziness ended a couple of weeks after but was not enough that he started wondering what the heck was happening until the fatigue kicked in at the end of March. The adverse events did not require a visit to Emergency Room or Physician Office.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Energy increased, Feeling abnormal, Hyperaesthesia
Clinical narrative: All senses seemed like they were amplified. Blues bluer, reds redder, sense of smell enhanced, sense of hearing enhanced; Seemed like had more energy; something kicked in like drinking espresso; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 80 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPERAESTHESIA (non-serious), outcome "unknown", described as "All senses seemed like they were amplified. Blues bluer, reds redder, sense of smell enhanced, sense of hearing enhanced"; ENERGY INCREASED (non-serious), outcome "unknown", described as "Seemed like had more energy"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "something kicked in like drinking espresso".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: minimal injection site pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 10:30 (Lot number: ER8727) at the age of 57 years as single dose for covid-19 immunisation. Relevant medical history included: "Diabetic" (ongoing); "Chronic bronchitis" (ongoing); "Chronic obstructive pulmonary disease" (unspecified if ongoing); "GERD" (ongoing); "Gastroparesis" (unspecified if ongoing); "essential hypertension, benign" (ongoing); "Mixed hyperlipidemia" (ongoing); "Hypoxia" (ongoing); "obstructive sleep apnea" (ongoing); "Lymphedema" (ongoing); "Osteoarthritis" (ongoing); "Vitamin D deficiency" (ongoing); "smoker" (unspecified if ongoing); "low back pain" (ongoing), notes: she's been on pain medicine several years due to low back pain and she takes the pain medicine anywhere from every 4-6 hours. Concomitant medication(s) included: GUAIFENESIN (ongoing); BAYER BACK & BODY PAIN taken for pain. Vaccination history included: Shingrix vaccine, administration date: 25Jun2019, reaction(s): "really painful". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Mar2021, outcome "recovered" (2021), described as "minimal injection site pain".  Additional information: Hydrocodone/acetaminophen 7.5-325 mg 1 tablet by mouth 4 times a day as needed. She generally takes it every 4-6 hours. She also takes Bayer Back and Body Extra Strength to supplement her pain medicine, 500mg coated caplet she takes one every 6 hours, the medication in the Bayer back and body is aspirin 500mg and caffeine. She occasionally takes 2 if she's having extreme pain.   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(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Mar2021 16:00 (Lot number: EN6205) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), administration date: 17Feb2021, when the patient was 79 years old, for COVID-19 IMMUNISATION. The following information was reported: FATIGUE (non-serious) with onset 12Mar2021, outcome "recovered", described as "fatigue". Therapeutic measures were not taken as a result of fatigue.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Fatigue, Pain
Clinical narrative: Chills; body aches; tired; bones in ribs hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 10:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BENADRYL. Vaccination history included: Bnt162b2 (Product=COVID 19 , Brand=Pfizer, Lot unknown=False, Administration date=23Mar2021, Administration time=10:00 AM, Vaccine location=Left arm, Dose number=1), administration date: 23Mar2021, when the patient was 34 years old, for Covid-19 immunisation, reaction(s): "Very cold fingers/cold ears, right leg and then entire body", "Numbness/numb fingers", "Tingling Fingers", "Cold ears, right leg and then entire body/cold feeling", "25Mar she developed hives all over her body in large welts". The following information was reported: CHILLS (non-serious) with onset 12Apr2021 15:00, outcome "recovering", described as "Chills"; PAIN (non-serious) with onset 12Apr2021 15:00, outcome "recovering", described as "body aches"; FATIGUE (non-serious) with onset 12Apr2021 15:00, outcome "recovering", described as "tired"; BONE PAIN (non-serious) with onset 12Apr2021 15:00, outcome "recovering", described as "bones in ribs hurt". Therapeutic measures were not taken as a result of chills, pain, fatigue, bone pain.No other vaccine taken in four weeks. No covid prior vaccination. No covid tested post vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: horrible pain in backs of upper legs between knees and butt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (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), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "horrible pain in backs of upper legs between knees and butt".  Additional information: She had her first covid vaccine shot with no issues. Reporter queried for if the symptoms she was experiencing are from the second Pfizer COVID 19 vaccine. Reporter states that she received second Pfizer COVID vaccine on 08Apr2021 and within 2 days, got horrible pains in backs of upper legs between knees and butt, unbelievable pain. Reporter queried for if this was a side effect from the shot. Reporter queried for to find out if what she experienced had been experienced by anyone else. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Somnolence
Clinical narrative: chills; aches; exhaustion; Mostly slept; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult 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 ({product=COVID 19, Lot_unknown=False,, Dose_number=1}]), for COVID-19 Immunization. The following information was reported: CHILLS (non-serious), outcome "recovered", described as "chills"; PAIN (non-serious), outcome "recovered", described as "aches"; FATIGUE (non-serious), outcome "recovered", described as "exhaustion"; SOMNOLENCE (non-serious), outcome "recovered", described as "Mostly slept". It was unknown if therapeutic measures were taken as a result of chills, pain, fatigue, somnolence.  Additional Information: It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine, any other medications the patient received within 2 weeks of vaccination, treatment received for the adverse event, if patient diagnosed with COVID-19 prior to vaccination, if patient had been tested for COVID-19 since the vaccination, any allergies to medications, food, or other products. Hospitalization was involved for adverse event. Patient reported, 12 hrs after the shot chills, aches and exhaustion that lasted 24 hrs. Went from her bed to the couch. Mostly slept.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.