chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Fatigue, Pain in extremity
Clinical narrative: sore right arm; Dizziness; Feeling of dehydration; Fatigue; This is a spontaneous report received from a contactable reporter.A 38 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 07May2021 13:00 (Lot number: EW0173) at the age of 38 years as dose 2, single for COVID-19 immunization. Relevant medical history included: "pregnant" (unspecified if ongoing); "Anal Fissure" (unspecified if ongoing), notes: Verbatim: Anal Fissure; "Know Allergies: Hornet stings" (unspecified if ongoing), notes: Know Allergies: Hornet stings. Date of last menstrual period: 02Feb2021. The patient was 13 weeks pregnant at the time of exposure to bnt162b2. The patient was 13 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 09Nov2021. Concomitant medication(s) included: MVI [ASCORBIC ACID;DEXPANTHENOL;ERGOCALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]; VIT D3; NIFEDIPINE. Vaccination history included: Bnt162b2 (Dose number: 1, Product: COVID 19 , Brand: Pfizer, Lot number: EW0161, Lot unknown: False, Administration date: 16Apr2021, Administration time: 01: 00 PM, Vaccine location: Left arm, ), administration date: 16Apr2021, for COVID-19 immunization, reaction(s): "sore left arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08May2021 06:00, outcome "recovered" (2021), described as "sore right arm"; DIZZINESS (non-serious) with onset 08May2021 06:00, outcome "recovered" (2021), described as "Dizziness"; DEHYDRATION (non-serious) with onset 08May2021 06:00, outcome "recovered" (2021), described as "Feeling of dehydration"; FATIGUE (non-serious) with onset 08May2021 06:00, outcome "recovered" (2021), described as "Fatigue". Therapeutic measures were not taken as a result of pain in extremity, dizziness, dehydration, fatigue.  Additional information: Reporter stated after shot 2 experienced sore right arm and could not sleep due to soreness. Then next day dizziness, feeling of dehydration and fatigue was noted. Lasted about 24 hours. Other vaccines in four weeks, COVID prior and post vaccination were none.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: His wife is not feeling well that's why they cannot get their dose today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MALAISE (non-serious) with onset 05May2021, outcome "unknown", described as "his wife is not feeling well that's why they cannot get their dose today".  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-2021517115
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: colds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), described as "colds".  Additional Information: Patient was due to get the 2nd dose of the vaccine tomorrow which was  06May2021 and she was currently experiencing colds. Patient wanted to know if it was safe to proceed in getting the second dose of the vaccine. Call got disconnected while confirming the date of the 1st dose so call was not transferred. Created Manual AE Form.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body Aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient, based on the information received by Pfizer from RA (Reference ID.   A 56 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 56 years 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: PAIN (non-serious), outcome "unknown", described as "Body Aches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: very high blood pressure; 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: HYPERTENSION (non-serious), outcome "unknown", described as "very high blood pressure".  Additional information: The caller took the covid vaccine and she has experienced very high blood pressure, it was sky high, and it has never been like this before. The caller wants some data about the trials. Since the caller had the covid vaccine, her blood pressure has seem to have gone high and she doesn't attribute it to a change in diet or anything.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Illness, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: I have been sick; Sore throat; Fatigue; 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 15Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 04May2021, outcome "unknown", described as "I have been sick"; OROPHARYNGEAL PAIN (non-serious) with onset 04May2021, outcome "unknown", described as "Sore throat"; FATIGUE (non-serious) with onset 04May2021, outcome "unknown", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: When probed for the concern, consumer stated, "I was originally supposed to get my Pfizer second dose tomorrow (07May2021) but for the past two days I have been sick, I have like a sore throat and fatigue. I got tested got tested today and I was negative for Covid but I was wondering when I should get my second dose. I wasn't sure there like should I be able to take as I am sick now".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Menstrual disorder
Clinical narrative: Constipation &  bad menstrual cycle after 1st shot.; Constipation &  bad menstrual cycle after 1st shot.; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 12:00 (Lot number: ER8732) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic constipation" (unspecified if ongoing); "Allergies: Allergic to contrast dye, red dyes" (unspecified if ongoing); "Allergies: milk products" (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LINZESS; L-LYSINE ACETATE; FLAX OIL. The following information was reported: MENSTRUAL DISORDER (non-serious), CONSTIPATION (non-serious), outcome "not recovered" and all described as "Constipation &  bad menstrual cycle after 1st shot.". Therapeutic measures were not taken as a result of menstrual disorder, constipation.  Additional information: Facility type vaccine: Pharmacy or Drug Store. Patient did not received covid prior vaccination. Patient did not covid tested post vaccination. Patient did not received any other vaccine in four weeks. Patient stated that Since her 2nd shot 2 weeks ago, her heart rate and body temp are elevated. She was hot all the time and can't sleep well, so she was tired. she also had her 1st herpes outbreak in 9 months.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chills, Palpitations
Clinical narrative: Chills; Palpitations/her heart was racing; Blood pressure went up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Lot number: EN9581) 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: CHILLS (non-serious), outcome "unknown", described as "Chills"; PALPITATIONS (non-serious), outcome "unknown", described as "Palpitations/her heart was racing"; BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "Blood pressure went up". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated she just wanted to know if she should take the second dose since she was fine now Patient stated in the beginning in the 15 minutes she was waiting her heart was racing and then it went down and was fine and then it started back again and also she had chills and her blood pressure went up. Patient stated within 3 weeks this happened maybe once or twice. Patient asked should she get the second dose.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; 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 female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 (Lot number: ER8735) at the age of 77 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: NAUSEA (non-serious) with onset 30Apr2021, outcome "not recovered", described as "nausea".  Additional information: The reporter stated she had been experiencing nausea that came in waves. The nausea really started about 3 hours after she received the vaccine. Investigation assessment was not reported.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness
Clinical narrative: Have had a stiff neck and bit of a headache on and off constantly; Have had a stiff neck and bit of a headache on and off constantly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Feb2021 (Lot number: EN2603) at the age of 71 years as dose 1, single and administered in arm left, administration date 19Mar2021 (Lot number: EN6204) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Verbatim: Blood pressure. Concomitant medication(s) included: VALSARTAN; ROSUVASTATIN. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), HEADACHE (non-serious) all with onset 27Feb2021, outcome "not recovered" and all described as "Have had a stiff neck and bit of a headache on and off constantly". Therapeutic measures were not taken as a result of musculoskeletal stiffness, headache.  Additional information: Consumer stated, since he got first Covid shot on the 26Feb, he had a stiff neck and bit of a headache on and off constantly and was having it ever since he had that shot and even it became worse after he had second shot.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent, reported for his daughter (patient) .  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information:Agent states the reporter on the line states they took the first dose yesterday, clarifies his wife and his two daughters. States the reporter was experiencing side effects, body aches, nausea, and tiredness. States his wife was experiencing a sore arm. Agent states the reporter was asking if those side effects are normal and if they will be up until the second dose. Agent provided reporter with medical information team. reporter states his wife and daughters are experiencing a sore arm, states his wife was also experiencing the tiredness.Reporter really just wants to know how long these symptoms are going to last. States if they are going to last until the 21 days until the second dose, he may not get the second dose because he does not like the way he was feeling. Also wants to know how effective the vaccine was if he only gets the one dose. Reporter declines to provide information for a report at this time, states he does not have time, just wants the answers to his questions.  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-2021518721 same reporter/product/event, different event.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fall, Malaise, Polydipsia
Clinical narrative: Light-headed; Fallen several times; I have missed all work and I don't know if I am going to be able to go because I am upset and not feeling good; I am also drinking over 2 gallon of water a day; 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 22Apr2021 (Batch/Lot number: unknown) as dose 1,single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Light-headed"; FALL (non-serious), outcome "unknown", described as "Fallen several times"; MALAISE (non-serious), outcome "unknown", described as "I have missed all work and I don't know if I am going to be able to go because I am upset and not feeling good"; POLYDIPSIA (non-serious), outcome "unknown", described as "I am also drinking over 2 gallon of water a day".  Additional Information: When probed for the concern, consumer stated, "Patient concern is that patient had first Pfizer one (shot) almost 2 weeks ago patient had it on April 22nd on Thursday morning. patient had been Light-headed, patient had collapsed, fallen over several times and this is almost 2 weeks later and still very Light-headed whether standing or sitting like going to fall. Patient also drinking over 2 gallon of water a day never done that. Patient had been to "ER" (not clarified) twice, had been to primary care and neurologist. Patient lab work is good, vitals are good, and they are saying that vaccine (unspecified vaccine) has did some reaction to some people. Patient missed the work all last week, missing work all this week and don't know if going to be able to go back because it's not going away.  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: Asthenia, Fatigue, Feeling abnormal, Limb discomfort, Pain
Clinical narrative: Lost Energy; Arms feel like he is carrying extra weight.; I feel weight on my shoulders; Aches on one side of the body, on the other side of his body, the left side, like elbow; Just a little pain where the injection went in on right arm in the shoulder; Also has some tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021513868 (Pfizer).  A 77 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05May2021 (Batch/Lot number: unknown) at the age of 77 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus", start date: 2015 (ongoing), notes: States his readings have been below 7. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 05May2021, outcome "not recovered", described as "Aches on one side of the body, on the other side of his body, the left side, like elbow"; VACCINATION SITE PAIN (non-serious) with onset 05May2021, outcome "not recovered", described as "Just a little pain where the injection went in on right arm in the shoulder"; FATIGUE (non-serious) with onset 05May2021, outcome "not recovered", described as "Also has some tiredness"; ASTHENIA (non-serious) with onset 06May2021, outcome "unknown", described as "Lost Energy"; LIMB DISCOMFORT (non-serious) with onset 06May2021, outcome "not recovered", described as "Arms feel like he is carrying extra weight."; FEELING ABNORMAL (non-serious) with onset 06May2021, outcome "unknown", described as "I feel weight on my shoulders".  Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Drinking Fluids and Aleve for Pain.  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: Vaccination site pain
Clinical narrative: Lost Energy; Arms feel like he is carrying extra weight.; I feel weight on my shoulders; Aches on one side of the body, on the other side of his body, the left side, like elbow; Just a little pain where the injection went in on right arm in the shoulder; Also has some tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021513868 (Pfizer).  A 77 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05May2021 (Batch/Lot number: unknown) at the age of 77 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus", start date: 2015 (ongoing), notes: States his readings have been below 7. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 05May2021, outcome "not recovered", described as "Aches on one side of the body, on the other side of his body, the left side, like elbow"; VACCINATION SITE PAIN (non-serious) with onset 05May2021, outcome "not recovered", described as "Just a little pain where the injection went in on right arm in the shoulder"; FATIGUE (non-serious) with onset 05May2021, outcome "not recovered", described as "Also has some tiredness"; ASTHENIA (non-serious) with onset 06May2021, outcome "unknown", described as "Lost Energy"; LIMB DISCOMFORT (non-serious) with onset 06May2021, outcome "not recovered", described as "Arms feel like he is carrying extra weight."; FEELING ABNORMAL (non-serious) with onset 06May2021, outcome "unknown", described as "I feel weight on my shoulders".  Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Drinking Fluids and Aleve for Pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment, Pain in extremity, Parosmia, Saliva discolouration, Taste disorder
Clinical narrative: he has a lousy memory; Used a shampoo that's orange and it has a weird smell like garlic or onion; Tasted smell of shampoo in mouth; Felt like saliva was orange; Sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 76 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 22Feb2021 (Batch/Lot number: unknown) at the age of 76 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot Number/Expiry Date: Unknown/Unknown , Route: Injection , Anatomical Location: Right arm), administration date: 30Jan2021, when the patient was 76 years old, for Covid-19 immunization.  The following information was reported: PAROSMIA (non-serious) with onset 23Feb2021, outcome "recovered" (23Feb2021), described as "Used a shampoo that's orange and it has a weird smell like garlic or onion"; TASTE DISORDER (non-serious) with onset 23Feb2021, outcome "recovered" (23Feb2021), described as "Tasted smell of shampoo in mouth"; SALIVA DISCOLOURATION (non-serious) with onset 23Feb2021, outcome "recovered" (23Feb2021), described as "Felt like saliva was orange"; PAIN IN EXTREMITY (non-serious) with onset 22Feb2021, outcome "recovered" (22Feb2021), described as "Sore arm"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "he has a lousy memory".  Additional information: Vaccination time for second dose between 13:00 and 14:00. The patient had received Shingles vaccine within 4 weeks administered in arm via injection route for flu on 12Jan2021 had experienced immediately got the flu. Description of complaint: Immediately got the flu after receiving the flu shot. Caller reported that the event occurred 3 decades or longer ago. Caller unable to provide product details.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Headache
Clinical narrative: I am having headache and it is at the back of my head; I am kind of dizzy; looks like I am confused; I am kind of dizzy; looks like I am confused; 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 05May2021 05:40 (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) with onset May2021, outcome "unknown", described as "I am having headache and it is at the back of my head"; DIZZINESS (non-serious), CONFUSIONAL STATE (non-serious) all with onset May2021, outcome "unknown" and all described as "I am kind of dizzy; looks like I am confused".  Additional Information: Reason for no lot number: Consumer stated, I think my card is in the car, Sorry. Consumer stated, I got my vaccination done, it was Pfizer vaccine first dose and I have been noticing that my head I am having headache and it is at the back of my head and I am kind of dizzy and looks like I am confused you know, It was my first dose of Vaccine. Consumer stated, further probing could not be done as consumer dont want to share further information. Hence, limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: my hands are swollen; 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: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "my hands are swollen". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 04May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset May2021, outcome "unknown", described as "Sore arm"; FATIGUE (non-serious) with onset May2021, outcome "unknown", described as "tiredness".  Additional information: The reporter really just wanted to know how long these symptoms were going to last. Stated if they were going to last until the 21 days until the second dose, he might not get the second dose because he did not like the way he was feeling. Also wanted to know how effective the vaccine was if he only gets the one dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: My lymph nodes under my arms and in my groin are swollen; 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: LYMPHADENOPATHY (non-serious) with onset 07Apr2021, outcome "unknown", described as "My lymph nodes under my arms and in my groin are swollen".  Additional information: The patient informed that lymph nodes under the patient arms and in my groin are swollen. The patient was enquiring if that go away or was asking if somebody else who can hear the patient and stated was screaming into the telephone. Appropriate response could not be provided as patient's voice was not completely audible to the Call handler. A Call back was done to gather more information but was not successful. Limited information was available over the call.  Comment: Name of the suspect product was not available over the call, hence captured as Unspecified Medication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 -old female patient received bnt162b2 (BNT162B2), administration date 20Apr2021 (Batch/Lot number: unknown) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "mono" (unspecified if ongoing). Concomitant medication(s) included: NIKKI taken for contraception. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Soreness in my arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: hasn't been feeling well since getting the first dose of the vaccine; Nausea; This is a spontaneous report received from a non-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 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "hasn't been feeling well since getting the first dose of the vaccine"; NAUSEA (non-serious), outcome "unknown", described as "Nausea".  Additional information: The patient was not related to a study or programme. It was reported that the patient was scheduled for second vaccine tomorrow. It was reported that, the patient had not feel well since getting the first dose of the vaccine. The patient wanted to know anything that she can take for nausea. Patient want to know if she can reschedule her appointment, how long would wait to get the second dose. She heard that the second dose would be worse. She had spoken to a pharmacist and was not told anything.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Irritability, Tremor
Clinical narrative: My hand is just shaking; It's like my fingers, especially my thumb is just shaking; it's kind of annoying; My hand is just shaking; It's like my fingers, especially my thumb is just shaking; it's kind of annoying; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 06May2021 10:00 (Lot number: EW0183) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, lot number: EW0164), administration date: 15Apr2021, when the patient was 60 years old, for Covid-19 immunization. The following information was reported: TREMOR (non-serious), IRRITABILITY (non-serious) all with onset 06May2021, outcome "unknown" and all described as "My hand is just shaking; It's like my fingers, especially my thumb is just shaking; it's kind of annoying". Additional information: The patient got the second Pfizer vaccine today and noticed that hand was just shaking. It was 4 O clock there and patient got the shot around 10 am. So that was something that never happened. It was like patient fingers, especially thumb was just shaking. When paraphrased the above concern, consumer wanted to report it because patient did not hear of it and saw many people reporting it. Patient wanted to keep Pfizer know. It was not like patient need to go the emergency or anything, but it was definitely because of the vaccine, and it was on the same arm too, where patient got the vaccine. The patient was going to try stretching and moving around to see if it gets better but was kind of annoying. Other than that patient just want to report it.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lip erythema, Lip pruritus, SARS-CoV-2 test
Clinical narrative: Edges of my lips are red and itchy; Edges of my lips are red and itchy; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03May2021 15:30 (Lot number: EW0182) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL; TURMERIC [CURCUMA LONGA]; MELATONIN; HYDROCHLOROTHIAZIDE. Vaccination history included: Bnt162b2 (Dose: 1, Administration date: 05Apr2021 , Administration time: 12.15 PM , Lot number: ER8729), administration date: 05Apr2021, when the patient was 41 years old, for covid-19 immunization, reaction(s): "with the first vaccine I had vaginal irritation", "with the first vaccine I had vaginal irritation, redness,", "the skin started to peel". The following information was reported: LIP PRURITUS (non-serious), LIP ERYTHEMA (non-serious) all with onset 04May2021, outcome "not recovered" and all described as "Edges of my lips are red and itchy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lip pruritus, lip erythema. Additional information: he patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination. The treatment was given with Allegra and AZO.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Periarthritis
Clinical narrative: Arm and shoulder pain; Frozen shoulder; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2021 (Lot number: EL1283) as dose 1, single and administration date 25Jan2021 (Lot number: EL3249) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jan2021, outcome "unknown", described as "Arm and shoulder pain"; PERIARTHRITIS (non-serious) with onset Jan2021, outcome "unknown", described as "Frozen shoulder".  Additional information: Further stated that the patient called in regards to a reaction patient guess from the COVID Vaccine. It was pretty well ongoing since the time of the vaccine. patient first vaccine was on January 4 into left arm and the symptoms had not gone away, patient had arm and shoulder pain it was more than just slight pain." They were separate arms and the problem correlates with the first vaccine. The second vaccine was on January 25."Actually it was months ago and now it caused a frozen shoulder. patient want to report that because of the occurrence and others probably maybe in a similar situation and also stated definitely patient schedule for an injection to see if that help the frozen shoulder. patient not scheduled yet, that was the treatment recommendation."  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: I have been getting smell like cigarette smoking which is pretty intense; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 23Apr2021 (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 number: 1), for COVID-19 Immunization. The following information was reported: PAROSMIA (non-serious) with onset Apr2021, outcome "not recovered", described as "I have been getting smell like cigarette smoking which is pretty intense".  Additional information: It was reported that, patient had taken both the Pfizer Covid vaccine and patient took second shot on 23Apr and after that been getting the smell like cigarette smoking smell which was pretty intense and patient was wondering, what's the reason behind it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm after first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Apr2021 (Lot number: EW0150) at the age of 66 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Apr2021, outcome "recovered" (09Apr2021), described as "Sore arm after first dose".  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye pain, Headache, Hyperhidrosis, Oropharyngeal pain
Clinical narrative: chills; sweating; headache/ head hurt; throwing up; throat hurts; eyes and head hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02May2021 10:30 (Lot number: ew0172) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Bonadoxina, reaction(s): "Known Allergies: Bonadoxina". Vaccination history included: Bnt162b2 (DOSE 1, SNGLE, Lot number: ep1533, Administration time: 11:00, vaccine location: Right arm), administration date: 11Apr2021, when the patient was 39 years old, for COVID-19 Immunization, reaction(s): "delay in my period". The following information was reported: CHILLS (non-serious) with onset 02May2021 01:00, outcome "not recovered", described as "chills"; HYPERHIDROSIS (non-serious) with onset 02May2021 01:00, outcome "not recovered", described as "sweating"; HEADACHE (non-serious) with onset 02May2021 01:00, outcome "not recovered", described as "headache/ head hurt"; VOMITING (non-serious) with onset 02May2021 01:00, outcome "not recovered", described as "throwing up"; OROPHARYNGEAL PAIN (non-serious) with onset 02May2021 01:00, outcome "not recovered", described as "throat hurts"; EYE PAIN (non-serious) with onset 02May2021 01:00, outcome "not recovered", described as "eyes and head hurt". Therapeutic measures were taken as a result of chills, hyperhidrosis, headache, vomiting, oropharyngeal pain, eye pain.  Additional information: Other medications in two weeks were none. Patient received no other vaccine in four weeks. Patient was not pregnant at the time of vaccination. It was reported that first dose was fine, did not have any noticeable side effects but a delay in my period. Second dose got chills, excess sweating and splitting headache first night, felt better about 30 hours after the shot, then 30 hours after that went back to sweating and throwing up. throat hurts, eyes and head hurt. Therapeutic measures were taken as a result of the events included Tylenol. Patient did not have Covid prior vaccination and not tested for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: chills; sweating; headache/ head hurt; throwing up; throat hurts; eyes and head hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02May2021 10:30 (Lot number: ew0172) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Bonadoxina, reaction(s): "Known Allergies: Bonadoxina". Vaccination history included: Bnt162b2 (DOSE 1, SNGLE, Lot number: ep1533, Administration time: 11:00, vaccine location: Right arm), administration date: 11Apr2021, when the patient was 39 years old, for COVID-19 Immunization, reaction(s): "delay in my period". The following information was reported: CHILLS (non-serious) with onset 02May2021 01:00, outcome "not recovered", described as "chills"; HYPERHIDROSIS (non-serious) with onset 02May2021 01:00, outcome "not recovered", described as "sweating"; HEADACHE (non-serious) with onset 02May2021 01:00, outcome "not recovered", described as "headache/ head hurt"; VOMITING (non-serious) with onset 02May2021 01:00, outcome "not recovered", described as "throwing up"; OROPHARYNGEAL PAIN (non-serious) with onset 02May2021 01:00, outcome "not recovered", described as "throat hurts"; EYE PAIN (non-serious) with onset 02May2021 01:00, outcome "not recovered", described as "eyes and head hurt". Therapeutic measures were taken as a result of chills, hyperhidrosis, headache, vomiting, oropharyngeal pain, eye pain.  Additional information: Other medications in two weeks were none. Patient received no other vaccine in four weeks. Patient was not pregnant at the time of vaccination. It was reported that first dose was fine, did not have any noticeable side effects but a delay in my period. Second dose got chills, excess sweating and splitting headache first night, felt better about 30 hours after the shot, then 30 hours after that went back to sweating and throwing up. throat hurts, eyes and head hurt. Therapeutic measures were taken as a result of the events included Tylenol. Patient did not have Covid prior vaccination and not tested for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Headache, nausea and vomiting 42 hours past second dose- lasted for 7 hours.; Headache, nausea and vomiting 42 hours past second dose- lasted for 7 hours.; Headache, nausea and vomiting 42 hours past second dose- lasted for 7 hours.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administration date Apr2021 (Lot number: ER8727, EW0173) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, lot number=ER8727, EW0173,, lot unknown=False,, administration date=Apr/2021), administration date: Apr2021, when the patient was 51 years old, for COVID-19 immunisation, reaction(s): "lethargy", "soreness mild muscle aching". The following information was reported: HEADACHE (non-serious), NAUSEA (non-serious), VOMITING (non-serious) all with onset Apr2021, outcome "recovered" and all described as "Headache, nausea and vomiting 42 hours past second dose- lasted for 7 hours.". It was unknown if therapeutic measures were taken as a result of headache, nausea, vomiting.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling/numb feeling was reported as worsened.; Tingling/numb feeling; Tingling/numb feeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 12:00 (Lot number: ED7533) at the age of 52 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset Apr2021, outcome "not recovered" and all described as "Tingling/numb feeling"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Tingling/numb feeling was reported as worsened.".   Additional Information: No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccination within 4 weeks. No AE following prior vaccination. However, she was scared to do the second dose which is scheduled for 13May2021. The report not related to a study or programme. No other products, Investigation assessment reported as no. Reporter on the line calling about the Pfizer COVD Vaccine. She thinks she was having an adverse reaction and does not know where to start. She does not know if her doctor should be contacted. She was not seen the doctor yet. However, this event has not gone away. It's still lingering and getting worse. However, she may have to so see the doctor to determine if something different needs to be done. She did not have an address to provide for the HCP. She explained she got the vaccine on 22Apr2021 in her left arm. She clarified the adverse reaction as over a week now she has been feeling a tingling feeling from above her elbow of her left arm down to her fingertips. At times it is like a numbing feeling. She struggles to hold on to stuff because it is so tingly/numb. This feeling is more noticeable now. This started either 27Apr2021 or 28Apr2021. It started during the work hours, sometime between 8am-5pm CST. Vaccination facility type was pharmacy. Vaccine administered at facility was reported as does not believe so. History of all previous immunizations with the Pfizer vaccine considered as suspect reported as none, this was the first dose. The patient did not visit emergency room and physician's office. She is unsure if we should be aware of this too. AEs following prior vaccinations reported as none. Family Medical History Relevant to AE(s) reported as none. Relevant test reported as none. Stated she will call back if she has more questions. However, she is scared to do the second dose which is scheduled for 13May2021. Informed to reach out to doctor regarding questions about getting the second dose.  No follow-up attempts are possible. No further information is expected.