chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Bone swelling, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Fatigue; headache; swelling or a lump in clavicle; chills; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 27Apr2021 14:45 (Batch/Lot number: unknown) as dose 1, single and administered in arm left, administration date 27Apr2021 (Lot number: Unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy to aspirin" (unspecified if ongoing); "Allergy to penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Allergy to naproxen, reaction(s): "naproxen - Allergy", notes: Verbatim: Allergy to naproxen.  The following information was reported: FATIGUE (non-serious) with onset 19May2021 02:00, outcome "not recovered", described as "Fatigue"; HEADACHE (non-serious) with onset 19May2021 02:00, outcome "not recovered", described as "headache"; BONE SWELLING (non-serious) with onset 19May2021 02:00, outcome "not recovered", described as "swelling or a lump in clavicle"; CHILLS (non-serious) with onset 19May2021 02:00, outcome "not recovered", described as "chills"; DIARRHOEA (non-serious) with onset 19May2021 02:00, outcome "not recovered", described as "diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, headache, bone swelling, chills, diarrhoea.  Additional information: Patient was not received any vaccine in four weeks nor any medication in two weeks. Patient was not diagnosed with COVID-19 prior to vaccination and was tested for covid-19 since 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: SARS-CoV-2 test
Clinical narrative: Fatigue; headache; swelling or a lump in clavicle; chills; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 27Apr2021 14:45 (Batch/Lot number: unknown) as dose 1, single and administered in arm left, administration date 27Apr2021 (Lot number: Unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy to aspirin" (unspecified if ongoing); "Allergy to penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Allergy to naproxen, reaction(s): "naproxen - Allergy", notes: Verbatim: Allergy to naproxen.  The following information was reported: FATIGUE (non-serious) with onset 19May2021 02:00, outcome "not recovered", described as "Fatigue"; HEADACHE (non-serious) with onset 19May2021 02:00, outcome "not recovered", described as "headache"; BONE SWELLING (non-serious) with onset 19May2021 02:00, outcome "not recovered", described as "swelling or a lump in clavicle"; CHILLS (non-serious) with onset 19May2021 02:00, outcome "not recovered", described as "chills"; DIARRHOEA (non-serious) with onset 19May2021 02:00, outcome "not recovered", described as "diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, headache, bone swelling, chills, diarrhoea.  Additional information: Patient was not received any vaccine in four weeks nor any medication in two weeks. Patient was not diagnosed with COVID-19 prior to vaccination and was tested for covid-19 since the vaccination.  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: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 54-years-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Apr2021 (Lot number: EW0161) at the age of 54 years as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history included: "cholesterol" (unspecified if ongoing), notes: Verbatim: Cholesterol. Concomitant medication(s) included: OMEPRAZOLE taken for gastroesophageal reflux disease. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional Information: Consumer stated that I had got the first one on 21April2021, Saturday and did not have anything serious just the sore arm that was all and May 8th was the second vaccine. Well it was 17April2021 when they gave the first shot. LOT Number: Reporter stated that the LOT number for the first one is EW0161. I don't know they put down April 17th the date and I gave you wrong date, it is not 24April. 17April was the first shot. About anatomical site of administration, consumer stated on the left arm, both times. About medications consumer stated that no the only one is for acid reflux Omeprazole. About medical conditions, the consumer stated little bit of cholesterol, doctor keeps saying you need to lose weight. I am little bit fat, little bit round. About Laboratory test, consumer stated that not recently, since got the vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain running down her legs and sometimes her foot is involved; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 04Apr2021 (Lot number: ER8737) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Spinal stenosis" (unspecified if ongoing); "Pain in foot" (unspecified if ongoing), notes: She clarifies she has this issue sometimes. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain running down her legs and sometimes her foot is involved".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got real real sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (005570). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got real real sick". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site swelling
Clinical narrative: woke up with her left arm swollen( same arm where she got the injection) and lymph node under the arm is present.; woke up with her left arm swollen( same arm where she got the injection) and lymph node under the arm is present.; 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 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19May2021 (Batch/Lot number: unknown) at the age of 32 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 SWELLING (non-serious), LYMPHADENOPATHY (non-serious) all with onset 20May2021, outcome "unknown" and all described as "woke up with her left arm swollen( same arm where she got the injection) and lymph node under the arm is present.".  Additional information: She got her first dose yesterday. She woke up today and had left underarm swollen lymph node. It is the same arm that she got the vaccine in.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Feeling hot, Skin burning sensation
Clinical narrative: felt painful, hot, and burning like a spider bite; felt painful, hot, and burning like a spider bite; Pain in right side of back, shoulder blade; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04May2021 10:40 (Lot number: EW0161, Expiration Date: 31Jul2021) at the age of 77 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hives" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset 15May2021, outcome "recovering", described as "Pain in right side of back, shoulder blade"; FEELING HOT (non-serious), SKIN BURNING SENSATION (non-serious), outcome "unknown" and all described as "felt painful, hot, and burning like a spider bite".  Additional information: Caller states that on 15May2021 he was working in his yard and had a terrible pain pop up in the right side of his back, shoulder blade. States he thought he  had been bitted by a spider because it felt painful, hot, and burning like a spider bite. Caller states he went inside and had his wife look at the area and there was nothing there; it was perfectly normal looking. States that it has continued to hurt. The pain comes and goes but it is in the exact same area. States he feels it to some degree all the time, like if it was a muscle  problem. Says he doesn't know if this is something that has been experienced with the Covid Vaccine.Caller denies any medications, medical conditions, labs, testing, or treatments relevant to these events. Caller states that he actually does not take any medications.many years ago when he was in the Air Force they received multiple vaccines in each arm, each day. He states the vaccines were administered with an air gun that cut him.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Second dose: small headache; Second dose: feeling dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07May2021 (Lot number: EW0158) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (ongoing), notes: Verbatim: Blood pressure. Concomitant medication(s) included: METOPROLOL taken for blood pressure abnormal (ongoing). Vaccination history included: Bnt162b2 (First dose), for covid-19 immunisation.  The following information was reported: HEADACHE (non-serious) with onset 08May2021, outcome "not recovered", described as "Second dose: small headache"; DIZZINESS (non-serious) with onset 08May2021, outcome "not recovered", described as "Second dose: feeling dizzy".  Additional information: On the 08May2021 he had the dizziness and the headache. He had gotten up from sleeping and his head started feeling dizzy with a small headache, he's continued to have it. He was supposed to go somewhere with his wife this morning, 19May2021 but he told her to go without him and he would call Pfizer and ask for some guidance on what he needs to do. AE(s) following prior vaccinations was None. The events did not cause Emergency Room or Physician Office visit.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Condition aggravated, Tinnitus
Clinical narrative: The ringing was worse after the second vaccine; The ringing was worse after the second vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 10:00 (Lot number: EP6955) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "small hearing loss in her left ear" (unspecified if ongoing), notes: Caller states she has a small hearing loss in her left ear, but that is from age. Family history included: "ringing in her ears" (unspecified if ongoing), notes: her sister has ringing in her ears, after getting the Pfizer Covid 19 vaccine. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, Time the Vaccination Was Given: afternoon, Anatomical location: Left arm, Lot number: EN6202), administration date: 25Feb2021, when the patient was 74 years old, for COVID-19 immunization, reaction(s): "ringing in her ears". The following information was reported: CONDITION AGGRAVATED (non-serious), TINNITUS (non-serious), outcome "not recovered" and all described as "The ringing was worse after the second vaccine". The event "the ringing was worse after the second vaccine" and "the ringing was worse after the second vaccine" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller answers as it was getting a little better, and then on last Thursday, the ringing came back like it was when it started, and never went away. Caller states she went to the doctor and was told that it was alright to get the second vaccine. Caller reports that the ringing was worse after the second vaccine, but started getting better until last Thursday, and then it worsened, similar to when the ringing first started. Caller states she was given a test and it was reported as normal. Caller states she has a small hearing loss in her left ear, but that is from age. Prior Vaccinations within 4 weeks/within four weeks prior to the first administration date of the suspect vaccines: No  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Her sister, had the Pfizer Covid vaccine, and she hadringing in her ears; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 26Feb2021, outcome "unknown", described as "Her sister, had the Pfizer Covid vaccine, and she hadringing in her ears".
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Feeling abnormal, Headache, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: pain at injection site; sporadic headaches; experienced problems concentrating; brain was totally different than it was before that shot. it was odd; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 64-year-old female patient received bnt162b2 (BNT162B2), administration date 29Apr2021 (Lot number: EW0171) at the age of 64 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: diagnosed with Covid back in the fall prior to vaccination. Concomitant medication(s) included: PROPRANOLOL taken for gastroesophageal reflux disease. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at injection site"; HEADACHE (non-serious), outcome "not recovered", described as "sporadic headaches"; DISTURBANCE IN ATTENTION (non-serious), outcome "not recovered", described as "experienced problems concentrating"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain was totally different than it was before that shot. it was odd". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, headache, disturbance in attention.  Additional information: The patient had her first Pfizer Covid-19 Vaccine on 29April2021 (2 weeks ago), The patient has been experiencing trouble concentrating and headache. The patient brain was totally different than it was before that shot. it was odd. A few days out she started to have pain at injection site (she was aware of its effect), sporadic headaches. Pain mostly seemed on the left side of her head. The patient was treated with Aspirin or Advil (the patient stated that she had to take a 325 milligrams Aspirin, 2 of them at one dose, 1 Advil, whatever it was, that, it was 200 mg).  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Nausea, Pain in extremity, Vaccination site reaction
Clinical narrative: 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 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19May2021 21:06 (Lot number: EL3302) at the age of 51 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 (Pfizer Covid Vaccine: first dose: 27Apr2021, LOT: EW0161, Expiry Date: unknown, NDC: unknown, injection, left arm, unknown dosage, Vaccine Name: Pfizer Covid Vaccine, Lot Number / Expiry Date: LOT: EW0161/ Expiry: Unknown, Route, Anatomical Location: Left arm, No. of Previous Doses: First Dose, Date: 27Apr2021, Age at Immunization if date not available: 51 years), administration date: 27Apr2021, when the patient was 51 years old, for Covid-19 Immunisation. The following information was reported: NAUSEA (non-serious) with onset 19May2021 21:25, outcome "not recovered", described as "nausea"; PAIN IN EXTREMITY (non-serious) with onset 19May2021, outcome "not recovered", described as "soreness of the arm"; ASTHENIA (non-serious) with onset 19May2021, outcome "not recovered", described as "felt really weak"; VACCINATION SITE REACTION (non-serious) with onset 19May2021, outcome "not recovered", described as "having a magnet stick to her left arm"; FATIGUE (non-serious) with onset 19May2021, outcome "not recovered", described as "she's just feeling wiped out and drained".  Additional information: Patient has been a nursing assistant and a caregiver. Patient feeling wiped out and drained. She confirmed it began yesterday in the evening, last night, it's worsened, she just feels like she just wants to lay down.Patient asked if people have reported the same magnetic effects and if Pfizer is aware of this. She stated that she got her second dose on Friday at her job last night at  and its the first time that she's nauseous and it wont go away, and her arm is really sore. she wants to know why a magnet or even a quarter is sticking to her arm where she got the shot, nobody seems to know why. Events did not cause Emergency Room or Physician Office visit. Prior Vaccinations (within 4 weeks) was none.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feeling tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 40 year-old female patient received bnt162b2 (BNT162B2), administration date 16May2021 12:45 (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 no -1), for Covid-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset May2021, outcome "unknown", described as "feeling tired".  Additional information: Caller was calling on behalf of her daughter who took her second Pfizer Covid vaccine dose on16May2021. She reported her daughter was feeling tired and wanted to know if this was a normal side effect of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Myalgia, Oropharyngeal pain
Clinical narrative: swollen lymph node in the neck; Sore throat; some muscle ache; he is stuffy and wormy/he generally wasn't feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 18 year-old male patient received bnt162b2 (BNT162B2), administration date 14May2021 (Lot number: Unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph node in the neck"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sore throat"; MYALGIA (non-serious), outcome "unknown", described as "some muscle ache"; MALAISE (non-serious), outcome "unknown", described as "he is stuffy and wormy/he generally wasn't feeling well".  Additional information: patient had a little bit of swollen lymph node in the neck, that was Saturday on Sunday I don't know he generally wasn't feeling well, he thought he was coming down with something Monday he was doing okay for the most part but then Tuesday and Wednesday, he has a sore throat and then today still the sore throat but now having some muscle ache and he is stuffy and wormy so you know it is like the days later he is still experiencing some side effect, is that normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscles were sore; 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 70 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 70 years as dose 1, single and (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: MYALGIA (non-serious), outcome "unknown", described as "muscles were sore". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Muscle spasms, Muscle twitching
Clinical narrative: Generalized muscle spasms and twitches all over my body; Generalized muscle spasms and twitches all over my body; Gets worse when tired.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Mar2021 16:30 (Lot number: EN6208) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "GERD" (unspecified if ongoing); "tourettes" (unspecified if ongoing). Concomitant medication(s) included: XANAX; TRILEPTAL; FOCALIN XR ER; TYLENOL. Past drug history included: Fruits, notes: Fruits. The following information was reported: MUSCLE SPASMS (non-serious), MUSCLE TWITCHING (non-serious) all with onset 22Mar2021 08:00, outcome "not recovered" and all described as "Generalized muscle spasms and twitches all over my body"; FATIGUE (non-serious) with onset 22Mar2021 08:00, outcome "not recovered", described as "Gets worse when tired.". The events "generalized muscle spasms and twitches all over my body", "generalized muscle spasms and twitches all over my body" and "gets worse when tired." were evaluated at the physician office visit.  Additional information: Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included Trileptal, Focalin, Tylenol, Xanax. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient experienced generalized muscle spasms and twitches all over my body starting 1 hour after the 1st dose, worst the next day. Primarily in legs, but also arms neck and face and eye area. Almost continuous, every day since. Gets worse when tired. Never experienced similar before. The patient also received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number:ER8737, Expiry date: unknown), via an unspecified route of administration, administered on 11Apr2021 at 16:30 in Arm Left as dose 2, single for covid-19 immunisation.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fear, Illness
Clinical narrative: I got very sick from my second dose; I was sick, terrified; 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) (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: ILLNESS (non-serious), outcome "unknown", described as "I got very sick from my second dose"; FEAR (non-serious), outcome "unknown", described as "I was sick, terrified". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17May2021 17:20 (Lot number: EW0177) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (ongoing), notes: she has had acid reflux for umpteen years.; "Gastric surgery", start date: 11Dec2017 (unspecified if ongoing); "Gallbladder removed" (ongoing), notes: she had her gallbladder removed about 30 years ago. The patient's concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset 17May2021, outcome "not recovered", described as "Diarrhea". Therapeutic measures were taken as a result of diarrhoea.  Additional information: Vaccination facility: Pharmacy. Vaccine was not Administered at Facility. Additional vaccine on same date was none. Event did not resulted in Emergency Room and Physician Office visit. No prior vaccination within 4 weeks. It was reported she has been having diarrhea ever since she received the Covid-19 vaccine. Caller reported that she has taken Pepto-Bismol and the diarrhea has not stopped. diarrhea began an hour or two after she received the Covid-19 vaccine. when she takes the Pepto-Bismol, her diarrhea eases up a little bit. Pepto helped for a little while but then the diarrhea starts right back up. She also reported that tomorrow, 21May2021, she is going to try not drinking coffee to see if it helps her diarrhea.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dissociation
Clinical narrative: Dissociation for 30 minutes on first dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06May2021 09:30 (Batch/Lot number: unknown) at the age of 23 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CRYSELLE. Past drug history included: Hep b vaccine, reaction(s): "known_allergies", notes: known allergies: Hep B vaccine. The following information was reported: DISSOCIATION (non-serious), outcome "recovered", described as "Dissociation for 30 minutes on first dose". Therapeutic measures were not taken as a result of dissociation. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown that the patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Somnolence
Clinical narrative: Nausea; Diarrhea; Sleepiness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 09:00 (Lot number: EN6205) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nausea"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; SOMNOLENCE (non-serious) with onset 24Mar2021 15:00, outcome "recovered" (2021), described as "Sleepiness". Therapeutic measures were not taken as a result of nausea, diarrhoea, somnolence. No follow-up attempts are possible. No further information is expected.  Additional information: After the first dose had sleepiness which went away after 3 to 4 days.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: Her second dose taken this Tuesday and her platelet dropped to 111 thousand, they dropped 111 thousand since the first shot; 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 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18May2021 (Lot number: EW0186) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing), notes: Verbatim: Depression; "Anxiety" (unspecified if ongoing), notes: Verbatim: Anxiety; "COPD" (unspecified if ongoing), notes: Verbatim: COPD. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, EW0176, Left Arm), administration date: 27Apr2021, when the patient was 63 years old, for Covid-19 immunization. The following information was reported: PLATELET COUNT DECREASED (non-serious), outcome "unknown", described as "Her second dose taken this Tuesday and her platelet dropped to 111 thousand, they dropped 111 thousand since the first shot". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: her platelet dropped after the first shot and they continue to drop until she got the next shot then they dropped more. She was being treated for low platelets. When she got her first shot her platelets were around 50 and went to 305 up. She got her second shot this and now her platelets drop to 111,000.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient in his 60's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 7 decade as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose".  Additional information: The report is cross referenced to report ID. The caller called to report having runny nose that began a week after her first Covid vaccine. During the call she stated that she had a friend that also reported having a runny nose. The caller was only only able to provide the sex, approximate age of 68 years old and race of the patient. She was unable to provide any other details.   No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling of lymph node in left axilla; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Feb2021 15:00 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety/despression" (unspecified if ongoing), notes: Other medical history: Anxiety/depression. Concomitant medication(s) included: WELLBUTRIN; TOPAMAX; HYDROXIZINE. Vaccination history included: Bnt162b2 (Dose: 01, Lot unknown: True, administration time=12:00 PM, vaccine location=Left arm), administration date: 30Jan2021, when the patient was 43 years old, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 22Feb2021 16:00, outcome "not recovered", described as "Swelling of lymph node in left axilla". The event "swelling of lymph node in left axilla" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of lymphadenopathy. Additional Information: Patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Patient received medications within 2 weeks of vaccination were Wellbutrin, topamax, hydroxyzine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies. Device Date : 19May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, SARS-CoV-2 test
Clinical narrative: Right armpit is hurting. Lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17May2021 18:00 (Batch/Lot number: unknown) at the age of 13 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPH NODE PAIN (non-serious) with onset 19May2021, outcome "unknown", described as "Right armpit is hurting. Lymph nodes". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymph node pain. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information:  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine  Device Date : 19May2021
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Fatigue, Nasal congestion
Clinical narrative: pink eye; fatigue; slight nasal congestion; This is a spontaneous report received from a non-contactable reporter (Consumer).  A 21 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONJUNCTIVITIS (non-serious), outcome "unknown", described as "pink eye"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; NASAL CONGESTION (non-serious), outcome "unknown", described as "slight nasal congestion".  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-2021580089 same report/drug/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance, Tremor
Clinical narrative: Legs were trembling and she couldn't hardly walk; Legs were trembling and she couldn't hardly walk; She was feeling pretty bad; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 06May2021 (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: TREMOR (non-serious), GAIT DISTURBANCE (non-serious) all with onset May2021, outcome "unknown" and all described as "Legs were trembling and she couldn't hardly walk"; FEELING ABNORMAL (non-serious) with onset May2021, outcome "unknown", described as "She was feeling pretty bad".  Additional information: Patient explained that her legs were trembling and she couldn't hardly walk. Soon as she got inside she sat in a chair in the living room and stayed there from 330 until 1am the next morning. She was feeling pretty bad.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: felt like when it was touching my hand was giving me a blister; when I touch things or when I walk it feels like I am getting blister on my hand and on my feet; blister on my finger on one of my hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLISTER (non-serious), outcome "unknown", described as "felt like when it was touching my hand was giving me a blister; when I touch things or when I walk it feels like I am getting blister on my hand and on my feet; blister on my finger on one of my hand".  Additional information: Consumer stated, patient got Covid vaccine earlier, got it around like 4:15 or 4:30 approximately 4:34-4:35 when patient got it and patient didn't time but all of the sudden like patient was cleaning and when patient was holding the broom it was it felt like when it was touching hand and was giving a blister and now that doesn't make any sense but when touch things or when patient walk it feels like patient was getting blister on my hand and on my feet. Actually patient do have the blister on finger on one hand.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: legs are heavy; 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) (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: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "legs are heavy".  Additional information: Patient said that she has never had side effects before. Patient said after her shot her legs are heavy and it comes and goes. Patient said she had it in the beginning and it comes and goes. Patient asked, are there any exercises she can do to help that?. Patient said that she will see her primary care provider this month.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: cold; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 35 year-old 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: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold".  Additional information: Patient was scheduled to get a second dose of PFIZER-BIONTECH COVID-19 VACCINE tomorrow reported that he had cold. If patient will not get second dose tomorrow, when can patient get it?. Patient was asking, can second dose be administered later than 3 weeks?.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: muscle soreness at the site of the injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 15 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1 single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "muscle soreness at the site of the injection".  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, Nausea, Platelet count, Red blood cell count, Vomiting
Clinical narrative: vomiting; headaches; nausea; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 56 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Dec2020, stop date: Jan2021. Concomitant medication(s) included: IBRANCE taken for breast cancer, start date: 08Mar2021 (ongoing). The following information was reported: VOMITING (non-serious) with onset 2021, outcome "recovering", described as "vomiting"; HEADACHE (non-serious) with onset 2021, outcome "recovering", described as "headaches"; NAUSEA (non-serious) with onset 2021, outcome "recovering", described as "nausea". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: cycle Ibrance 100mg take one tablet daily for 21 days, 7 off with letrozole daily as prescribed by md. patient reports occasional missed doses, amount unknown. no side effects reported due to missed doses. reports missed doses due to side effects and at times due to md order to delay start of therapy cycle. patient reports after start of therapy, therapy hold (previously reported) due to having covid-19 from December 2020-beginning of January 2021, now resolved. patient reports after start of therapy, having covid-19 vaccine 1 and experiencing headaches, nausea, vomiting, all resolving after three days (dates unspecified). reported holding doses (unspecified amount) due to vaccine side effects. patient reports after start of therapy, since January decreased red blood cell count, white blood cell count, and platelet count and improved begging of May. md aware of all side effects and missed doses (as reported).  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count
Clinical narrative: vomiting; headaches; nausea; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 56 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Dec2020, stop date: Jan2021. Concomitant medication(s) included: IBRANCE taken for breast cancer, start date: 08Mar2021 (ongoing). The following information was reported: VOMITING (non-serious) with onset 2021, outcome "recovering", described as "vomiting"; HEADACHE (non-serious) with onset 2021, outcome "recovering", described as "headaches"; NAUSEA (non-serious) with onset 2021, outcome "recovering", described as "nausea". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: cycle Ibrance 100mg take one tablet daily for 21 days, 7 off with letrozole daily as prescribed by md. patient reports occasional missed doses, amount unknown. no side effects reported due to missed doses. reports missed doses due to side effects and at times due to md order to delay start of therapy cycle. patient reports after start of therapy, therapy hold (previously reported) due to having covid-19 from December 2020-beginning of January 2021, now resolved. patient reports after start of therapy, having covid-19 vaccine 1 and experiencing headaches, nausea, vomiting, all resolving after three days (dates unspecified). reported holding doses (unspecified amount) due to vaccine side effects. patient reports after start of therapy, since January decreased red blood cell count, white blood cell count, and platelet count and improved begging of May. md aware of all side effects and missed doses (as reported).  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A 43-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0161), at the age of 43, in right arm, on Apr 18, 2021, single dose, for COVID-19 immunisation. Medical history included alcoholism (unspecified if ongoing). Concomitant medication: baclofen taken for alcoholism. The patient experienced vaccination site pain (soreness in the arm after the first dose), onset Apr 18, 2021, with outcome of recovered (Apr 2021). Additional information: Baclofen started 6-9 months ago (more towards 9 months) with dose change every other week. Patient did not visit the emergency room or physician office. Soreness in the arm after first dose started a few hours later on Apr 18, 2021; and lasted roughly 1 to 1 ½ day. No follow-up attempts possible. No further information expected.