chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Feeling abnormal, Feeling hot
Clinical narrative: Tired/exhausted; Dizzy; sore arm; she is feeling "horrible, warm not like fever and exhausted"; weak; she felt like she was not in charge of her car; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administration date 08May2021 (Batch/Lot number: unknown) at the age of 38 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), when the patient was 38 years old, for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tired/exhausted"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FEELING HOT (non-serious), outcome "unknown", described as "she is feeling "horrible, warm not like fever and exhausted""; ASTHENIA (non-serious), outcome "unknown", described as "weak"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she felt like she was not in charge of her car".  Additional information: The patient noticed something on Saturday she was fine and Sunday she was tired, dizzy, and had a sore arm. She know some of the side effects that came with it but that had been 7 days. She reported that morning she was feeling weak, and very dizzy, and her arm still hurts. She says if she was being honest when she was driving this morning to drop her kids off from school she felt like she was not in charge of her car. She wanted to know if that was normal. She also reported that, when she got her shot, and she spent that whole week fasting, she was fasting yesterday and today is the first day of not having that. She had her coffee and wondered is this normal or is this a side effect of the vaccine. She asked how long are these side effects going to last. She reported on the data sheet it says if you have any severe allergy reactions then go to the hospital. She knew what's going on around her, she was just dizzy. She reported was not like she could breathe; she can breathe just fine. She was concerned about the dizziness and sore arm.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021547473 Same reporter/drug/event, different Patient
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Tired/exhausted; Dizzy; sore arm; she is feeling "horrible, warm not like fever and exhausted"; weak; she felt like she was not in charge of her car; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administration date 08May2021 (Batch/Lot number: unknown) at the age of 38 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), when the patient was 38 years old, for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tired/exhausted"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FEELING HOT (non-serious), outcome "unknown", described as "she is feeling "horrible, warm not like fever and exhausted""; ASTHENIA (non-serious), outcome "unknown", described as "weak"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she felt like she was not in charge of her car".  Additional information: The patient noticed something on Saturday she was fine and Sunday she was tired, dizzy, and had a sore arm. She know some of the side effects that came with it but that had been 7 days. She reported that morning she was feeling weak, and very dizzy, and her arm still hurts. She says if she was being honest when she was driving this morning to drop her kids off from school she felt like she was not in charge of her car. She wanted to know if that was normal. She also reported that, when she got her shot, and she spent that whole week fasting, she was fasting yesterday and today is the first day of not having that. She had her coffee and wondered is this normal or is this a side effect of the vaccine. She asked how long are these side effects going to last. She reported on the data sheet it says if you have any severe allergy reactions then go to the hospital. She knew what's going on around her, she was just dizzy. She reported was not like she could breathe; she can breathe just fine. She was concerned about the dizziness and sore arm.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021547473 Same reporter/drug/event, different Patient
Age: 40.0
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 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 13:45 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergy: sulfa drugs" (unspecified if ongoing), notes: Known allergy: sulfa drugs; "COVID-19", start date: Mar2020 (unspecified if ongoing), notes: I had Covid-19 in March 2020 (confirmed by antibodies in May 2020); "Chronic migraine" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: NORTRIPTYLINE; TIZANIDINE; PROPANOLOL [PROPRANOLOL]; ZOLPIDEM.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Injection site pain".  Additional Information: The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 21Apr2021 at 13:45 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, chronic migraine, COVID-19 in Mar2020 (confirmed by antibodies in May2020) and allergy to sulfa drugs. Concomitant medications included nortriptyline (MANUFACTURER UNKNOWN), tizanidine (MANUFACTURER UNKNOWN), propranolol (PROPANOLOL) and zolpidem (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021 the patient experienced injection site pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event vaccination site pain was resolved within a day on unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; 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 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13May2021 10:30 (Batch/Lot number: unknown) at the age of 58 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 number: 1, Anatomical location: Left arm), administration date: 12Apr2021, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 13May2021, outcome "not recovered", described as "tinnitus".  Additional information: Reporter stated that after receiving the Pfizer covid vaccine and patient had been experiencing aggravated tinnitus since yesterday afternoon. Reporter would like to know how long her tinnitus would last. Patient queried for should they go see their doctor if it still persists. In response to the query responded that tinnitus was not listed as a side effect as per document attached below: These may not be all the possible side effects of the Pfizer-BioNTech COVID-19 Vaccine. Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19 Vaccine was still being studied in clinical trials. Patient had not attended emergency room and physician room for event reported. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021547757 same reporter/drug/event, different patient;US-PFIZER INC-2021548332 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Eye irritation, Eye pain, Feeling abnormal
Clinical narrative: My eye felt like it was like a burning sensation, the right eye it was the corner of the eye, the outer part of the corner of the eye; turning red; it was like sore; My eye felt like it was like a burning sensation, the right eye it was the corner of the eye, the outer part of the corner of the eye; turning red; it was like sore; I felt really weird; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 13May2021 (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: FEELING ABNORMAL (non-serious) with onset 14May2021, outcome "unknown", described as "I felt really weird"; EYE IRRITATION (non-serious), EYE PAIN (non-serious) all with onset 14May2021 06:00, outcome "unknown" and all described as "My eye felt like it was like a burning sensation, the right eye it was the corner of the eye, the outer part of the corner of the eye; turning red; it was like sore". Therapeutic measures were taken as a result of eye irritation.  Additional Information: Patient got his second Covid vaccine yesterday. Patient had a massage today (at the time of report) and after massage patient felt really weird. Around 6 O'clock patient's eye felt like it was like a burning sensation, the right eye it was the corner of the eye, the outer part of the corner of the eye, it was like burning it was burning sensation so patient took the nap and got up, it felt like it burning really bad. So patient put a cold compress on it and it was turning red and patient took a Benadryl. So its definitely allergic type reaction, when patient took the rag, the cold compress and push it up it was like sore.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Migraine, Nasal congestion
Clinical narrative: nausea; migraine; body aches; tiredness/feeling very tired; feeling stuffy; chills; wasn't feeling good; where he got the injection there's a ball on his arm right there; 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 35 year-old male patient received bnt162b2 (BNT162B2), administration date 06May2021 (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 (First dose), for Covid-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 07May2021, outcome "unknown", described as "nausea"; MIGRAINE (non-serious) with onset 07May2021, outcome "unknown", described as "migraine"; PAIN (non-serious) with onset 07May2021, outcome "unknown", described as "body aches"; FATIGUE (non-serious) with onset 07May2021, outcome "unknown", described as "tiredness/feeling very tired"; NASAL CONGESTION (non-serious) with onset 07May2021, outcome "unknown", described as "feeling stuffy"; CHILLS (non-serious) with onset 07May2021, outcome "unknown", described as "chills"; MALAISE (non-serious) with onset 07May2021, outcome "unknown", described as "wasn't feeling good"; VACCINATION SITE MASS (non-serious) with onset 07May2021, outcome "unknown", described as "where he got the injection there's a ball on his arm right there".  Additional information: When the patient woke up the day after he received the vaccine, he was feeling very tired, he had a migraine for two days, chills, body aches all over his body, nausea, and where he got the injection there's a ball on his arm right there.  The caller wasn't feeling good so he called out of work because he wouldn't be able to function properly.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Vaccination site mass
Clinical narrative: nausea; migraine; body aches; tiredness/feeling very tired; feeling stuffy; chills; wasn't feeling good; where he got the injection there's a ball on his arm right there; 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 35 year-old male patient received bnt162b2 (BNT162B2), administration date 06May2021 (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 (First dose), for Covid-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 07May2021, outcome "unknown", described as "nausea"; MIGRAINE (non-serious) with onset 07May2021, outcome "unknown", described as "migraine"; PAIN (non-serious) with onset 07May2021, outcome "unknown", described as "body aches"; FATIGUE (non-serious) with onset 07May2021, outcome "unknown", described as "tiredness/feeling very tired"; NASAL CONGESTION (non-serious) with onset 07May2021, outcome "unknown", described as "feeling stuffy"; CHILLS (non-serious) with onset 07May2021, outcome "unknown", described as "chills"; MALAISE (non-serious) with onset 07May2021, outcome "unknown", described as "wasn't feeling good"; VACCINATION SITE MASS (non-serious) with onset 07May2021, outcome "unknown", described as "where he got the injection there's a ball on his arm right there".  Additional information: When the patient woke up the day after he received the vaccine, he was feeling very tired, he had a migraine for two days, chills, body aches all over his body, nausea, and where he got the injection there's a ball on his arm right there.  The caller wasn't feeling good so he called out of work because he wouldn't be able to function properly.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dry mouth
Clinical narrative: dry mouth; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRY MOUTH (non-serious), outcome "unknown", described as "dry mouth".  Additional information: Reporter stated he had a friend that also had dry mouth. Reporter stated he said he also called a friend and her sister who was also an RN (Registered Nurse) and she said her friend also had dry mouth. Reporter stated that it just went away but tried to look into the website and see if that was the reported symptom and couldn't find anything, so that's why thought would call and ask.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021541863 Same reporter/ drug/ event for different patients
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: had little pain at the point of the injection of the first one; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Feb2021 (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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "had little pain at the point of the injection of the first one". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that the patient first experiences the needle pinch, the vaccine hit patient muscle inside it's hard to describe but it's an interior sensation. Patient had any of those sensations with the second dose and also patient had little pain at the point of the injection of the first one. So the second one it was so minimal patient went inside for 15 minute and soon as patient was ready to get up and leave. And then couple of weeks ago, two weeks ago patient decided to make a doctor's appointment anyways to get the 'Anti' SARS CoV-2, Spike Protein Antibody Test, it's little bit above the number for the person to have one dose of the vaccine and it's about 70% lower than the lowest immune response, the lowest number of antibody a person would have received with the two doses. And there about I have looked at the studies of the distribution and I am not trying to make a claim about the immunity.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness of the arm; 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 67 year-old male patient received bnt162b2 (BNT162B2), administration date 06Apr2021 10:30 (Lot number: EW1058) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "back pain from back surgery" (unspecified if ongoing), notes: had years ago. Concomitant medication(s) included: TYLENOL.The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Apr2021, outcome "recovering", described as "soreness of the arm". Therapeutic measures were taken as a result of pain in extremity.  Additional information: There are no other products no patient history. Reporter stated that, he got the vaccine last month (i.e., 06Apr2021) and he still has soreness of the arm. reporter stated that, the doctor told him that he could have side effects up to 6 months. Reporter stated this started with his first shot and continued when he got the second shot on 28Apr2021. Caller stated he still has pain in his arm and a little minor headache, but it is not serious and just wants to make sure this is safe. reporter stated the soreness of the arm happens off and on and is a little better. Reporter stated he has taken over the counter Tylenol and it helped a little bit. No Additional Vaccines Administered. There are no Prior Vaccinations within 4 weeks. Reporter stated he usually gets the flu shot and pneumonia shot around October or November.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: The left side of my tongue has a tingling sensation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA ORAL (non-serious), outcome "unknown", described as "The left side of my tongue has a tingling sensation". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from a contactable reporter. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache".  Additional Information: Consumer stated that the reason he was calling because he took my Pfizer first shot on (26Feb2021) and second shot on 19Mar2021 and had taken this we going to be ringing in ears last 35 (not clarified) and after the first shot he ended up getting headache not thinking too much about it but very highly and after his second shot it even got worse and already been to the doctor to see if he found out anybody having any problem with Covid shots concerning the ringing in ears. Consumer was informed about Pfizer. And in response to it further stated that his hearing was not very good, so he was stressing right now.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Lymphadenopathy, Malaise
Clinical narrative: Feeling kind of rundown; lymph node in my neck have been swollen; Feeling not well; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a sponsored program (004756). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Apr2021 (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: DEPRESSED MOOD (non-serious), outcome "unknown", described as "Feeling kind of rundown"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "lymph node in my neck have been swollen"; MALAISE (non-serious), outcome "not recovered", described as "Feeling not well".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: My right hand, the thumb, it looks distorted, I guess it swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11May2021 (Lot number: EWO172, Expiration Date: 31Aug2021) at the age of 67 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number:1), administration date: 20Apr2021, when the patient was 67 years old, for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 12May2021, outcome "unknown", described as "My right hand, the thumb, it looks distorted, I guess it swollen". Therapeutic measures were not taken as a result of peripheral swelling.  Additional information: Consumer stated that It looked swollen, when the patient open the hand and had palm facing, it just looked distorted, it looked swollen but it was not discolored or anything. Patient was asking If the patient had a blood clot or something like that it would be discolored would not. The patient stated that right hand, the thumb, it looks distorted, guessed it swollen. But it was not discolored or anything, the skin tone was normal. The patient was concerned whether it was a side effect from the Pfizer shot.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: at the injection site it is as big as a goose egg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 91 year-old female patient received bnt162b2 (BNT162B2), administration date 13May2021 (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: VACCINATION SITE MASS (non-serious) with onset 13May2021, outcome "unknown", described as "at the injection site it is as big as a goose egg".  Additional information: He says they waited 15 minutes like they are supposed to and everything was fine. He says she had an appointment at the chiropractor and she was wearing a jacket. He says they took the jacket off and at the injection site it is as big as a goose egg, it was swollen. He says it was not swollen when they waited the 15 minutes and she is otherwise okay. He confirms he is talking about the Pfizer COVID-19 vaccine. He says it is not bruised, not red. He says he is concerned about what to do right now. He says she is not experiencing any other symptoms other than the injection site. He says he wants to figure out what to do, she doesn't have any other symptoms. He says he figured we would have answers or to be able to tell him if this is unusual. He says maybe he can find out something in general. He says calling us is the best thing because a family doctor will says that they have never seen this before; most people will say they have never seen this. He says he's be happy to report later and he is happy she is not passed out and falling over. He declines to complete the report at this time. No further information provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Poor quality sleep, Vaccination site swelling
Clinical narrative: headache; Unable to fall asleep; feel achy; swelling under the arm of injection site; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 17 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; POOR QUALITY SLEEP (non-serious), outcome "unknown", described as "Unable to fall asleep"; PAIN (non-serious), outcome "unknown", described as "feel achy"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swelling under the arm of injection site".  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, Pain in extremity
Clinical narrative: Light headed; Nausea; fatigue; Slightly sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fatty liver" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN; MELOXICAM; OMEGA 369 [BORAGO OFFICINALIS OIL;FISH OIL;OLEA EUROPAEA OIL]. Past drug history included: Tramadol, reaction(s): "Drug Allergy". The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Light headed"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Slightly sore arm".  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the 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: Back pain, Pain, Pain in extremity
Clinical narrative: Patient experienced body aches, specifically lower back aches; Patient experienced body aches, specifically lower back aches; Pain under arm gland of injection site.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient in her 50's 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 (First Dose), for Covid-19 immunization. The following information was reported: BACK PAIN (non-serious), PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "Patient experienced body aches, specifically lower back aches"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Pain under arm gland of injection site.".  Additional information: It was reported that patient experienced body aches, specifically lower back aches and pain under arm gland of 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: Neuralgia, Pain in extremity
Clinical narrative: Neuropathic pain in both legs; Bi-lateral leg pain; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 83 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "spinal stenosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Gabapentin, reaction(s): "did not tolerate", notes: the patient did not tolerate gabapentin. The following information was reported: NEURALGIA (non-serious), outcome "unknown", described as "Neuropathic pain in both legs"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Bi-lateral leg pain".  Additional information: The patient had Bi-lateral leg pain within 1-2 days of her 1st Pfizer COVID vaccine. Pain persisted. Reporter mentioned that it sounded like the patient might be experiencing neuropathic pain in both legs. The patient had a history of diabetes and spinal stenosis. It was a female patient 83 years of age. Reporter mentioned that the patient did not tolerate gabapentin, reporter was not sure if this was used previous to the patients 1st vaccine for COVID. The doctor did not share the patients initials. Company representative told to reporter that." I would report this and he was ok if someone reached out to him for more specifics". Event took place after use of product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Stomach pain after the Covid-19 shot, I got it on the first dose and now I still get it on the second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: Unknown) as dose 1, single and (Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Stomach pain after the Covid-19 shot, I got it on the first dose and now I still get it on the second dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14May2021 14:00 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertensive" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15May2021 08:00, outcome "not recovered", described as "arm pain". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Lisinopril 10 mlg within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site joint movement impairment
Clinical narrative: the injected arm was very sore to lift above shoulder level.; the injected arm was very sore to lift above shoulder level.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 10:00 (Batch/Lot number: unknown) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ECHINACEA; MULTIVITAMIN [VITAMINS NOS]. The following information was reported: PAIN IN EXTREMITY (non-serious), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "the injected arm was very sore to lift above shoulder level.".  Additional Information: The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Chills, Muscle spasms, Pain
Clinical narrative: full bodyaches; body temperature dropped; chills; horrible muscle cramps; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Apr2021 14:15 (Lot number: ER8734) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Soy allergy" (unspecified if ongoing), notes: anything with eggs or soy; "Egg allergy" (unspecified if ongoing), notes: anything with eggs; "Nerve damage" (unspecified if ongoing), notes: nerve damage left arm; "EBV" (unspecified if ongoing). Concomitant medication(s) included: SPIRULINA [SPIRULINA SPP.]; VITAMIN D NOS; VITAMIN C [ASCORBIC ACID]. The following information was reported: PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "full bodyaches"; BODY TEMPERATURE DECREASED (non-serious) with onset Apr2021, outcome "unknown", described as "body temperature dropped"; CHILLS (non-serious) with onset Apr2021, outcome "unknown", described as "chills"; MUSCLE SPASMS (non-serious) with onset Apr2021, outcome "unknown", described as "horrible muscle cramps". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, body temperature decreased, chills, muscle spasms.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included body temperature: body temp dropped to 96.1 in Apr2021. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Neck pain
Clinical narrative: Pain in the right side of my neck; Extreme weakness; This is a spontaneous report received from a contactable reporter A 71 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Mar2021 10:30 (Lot number: EN6206, Expiration Date: 30Jun2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hyperthyroidism", start date: 1978 (ongoing), notes: Illness/AE: Hyperthyroidism, Stop date: Ongoing, Pertinent Details: Levothyroxine; "Abnormal electrical heart signals", stop date: 22May2021, notes: Illness/AE: Abnormal electrical heart signals, Onset date: Birth, Pertinent Details: SVT Ablation; "Cholesterol Build up", start date: Apr2019, stop date: 18Oct2019, notes: Illness/AE: Cholesterol Build up, Pertinent Details: Pravastatin 40mg; "Torn meniscus knee", start date: 09Jan2019, stop date: 12Aug2019, notes: Illness/AE: Torn meniscus knee, Pertinent Details: Knee surgery 2 months rehabilitation. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st dose, Time: 10:15, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EN6198, Exp date: 30Jun2021), administration date: 20Feb2021, for COVID-19 immunisation. The following information was reported: NECK PAIN (non-serious), outcome "recovered", described as "Pain in the right side of my neck"; ASTHENIA (non-serious) with onset 14Mar2021, outcome "recovered" (2021), described as "Extreme weakness". Therapeutic measures were not taken as a result of neck pain, asthenia.  Additional information: Reporter reported that he experience increase in heart rate the next day after vaccination on 21Feb2021- excess so he was stayed quiet and elevated in bed at 35% incline and slept for 4 hours Second vaccine caused pain in right side of in his neck and difficulty moving head to right use Voltaren arthritis rub and heat pad for a few hours since he was home care worker for my son who was a stroke victim I did not seek family doctor.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Joint swelling
Clinical narrative: General fatigue; Ill felling; tingling in left hand and fingers; Dizzyness; Slight swelling of left wrist; Chills; sweat (no measurable fever)during the night; Swollen, painful lymph node under left arm; Swollen, painful lymph node under left arm; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 11:00 (Lot number: EW0161) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Exertional asthma" (unspecified if ongoing), notes: exercise and allergy induced asthma, (mild); "Allergic asthma" (unspecified if ongoing), notes: allergy induced asthma, (mild). There were no concomitant medications. The following information was reported: PARAESTHESIA (non-serious) with onset 23Apr2021 11:10, outcome "unknown", described as "tingling in left hand and fingers"; DIZZINESS (non-serious) with onset 23Apr2021 11:10, outcome "recovered" (23Apr2021 11:40), described as "Dizzyness"; JOINT SWELLING (non-serious) with onset 23Apr2021 11:10, outcome "unknown", described as "Slight swelling of left wrist"; CHILLS (non-serious) with onset 23Apr2021, outcome "unknown", described as "Chills"; NIGHT SWEATS (non-serious) with onset 23Apr2021, outcome "unknown", described as "sweat (no measurable fever)during the night"; FATIGUE (non-serious) with onset 24Apr2021, outcome "unknown", described as "General fatigue"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 23Apr2021, outcome "recovering" and all described as "Swollen, painful lymph node under left arm"; MALAISE (non-serious) with onset 24Apr2021, outcome "unknown", described as "Ill felling".  Additional information: The patient did not have a history of allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within four weeks prior to COVID vaccine. Concomitant medication was reported as none. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: no measurable fever on 23Apr2021. It was not reported whether any therapeutic measures were taken as a result of the events. Dizziness was gone after 30 minutes.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Malaise, Night sweats, Paraesthesia
Clinical narrative: General fatigue; Ill felling; tingling in left hand and fingers; Dizzyness; Slight swelling of left wrist; Chills; sweat (no measurable fever)during the night; Swollen, painful lymph node under left arm; Swollen, painful lymph node under left arm; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 11:00 (Lot number: EW0161) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Exertional asthma" (unspecified if ongoing), notes: exercise and allergy induced asthma, (mild); "Allergic asthma" (unspecified if ongoing), notes: allergy induced asthma, (mild). There were no concomitant medications. The following information was reported: PARAESTHESIA (non-serious) with onset 23Apr2021 11:10, outcome "unknown", described as "tingling in left hand and fingers"; DIZZINESS (non-serious) with onset 23Apr2021 11:10, outcome "recovered" (23Apr2021 11:40), described as "Dizzyness"; JOINT SWELLING (non-serious) with onset 23Apr2021 11:10, outcome "unknown", described as "Slight swelling of left wrist"; CHILLS (non-serious) with onset 23Apr2021, outcome "unknown", described as "Chills"; NIGHT SWEATS (non-serious) with onset 23Apr2021, outcome "unknown", described as "sweat (no measurable fever)during the night"; FATIGUE (non-serious) with onset 24Apr2021, outcome "unknown", described as "General fatigue"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 23Apr2021, outcome "recovering" and all described as "Swollen, painful lymph node under left arm"; MALAISE (non-serious) with onset 24Apr2021, outcome "unknown", described as "Ill felling".  Additional information: The patient did not have a history of allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within four weeks prior to COVID vaccine. Concomitant medication was reported as none. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: no measurable fever on 23Apr2021. It was not reported whether any therapeutic measures were taken as a result of the events. Dizziness was gone after 30 minutes.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Paraesthesia
Clinical narrative: Experienced "tingling" feeling in inner thighs; Later her right ankle "swelled up"; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 16 year-old female patient received bnt162b2 (BNT162B2), administration date May2021 (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: PARAESTHESIA (non-serious), outcome "unknown", described as "Experienced "tingling" feeling in inner thighs"; JOINT SWELLING (non-serious), outcome "unknown", described as "Later her right ankle "swelled up"".  Additional information: Swap reported 16 year old patient received first dose last weekend, experienced "tingling" feeling in inner thighs, later her right ankle "swelled up," asked if they can provide any medical advice on whether it is safe to provide second dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort, Oral pruritus
Clinical narrative: her mouth, discomfort; her mouth, discomfort and itchiness.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002191). The reporter is the parent.  An adult 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: ORAL DISCOMFORT (non-serious), outcome "unknown", described as "her mouth, discomfort"; ORAL PRURITUS (non-serious), outcome "unknown", described as "her mouth, discomfort and itchiness.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.