chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain on the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 (Lot number: EN6208) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma", start date: 2009 (ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 15Mar2021, outcome "recovered" (2021), described as "pain on the injection site".  Additional information: No prior Vaccinations within four weeks of the suspect vaccine. Reported that, Patient had the 1st dose of PFIZER-BIONTECH COVID-19 VACCINE last on 15Mar2021, Developed pain on the injection site of left arm starting 15Mar2021 and it was resolved which only lasted about a day or two. Outcome of that event unable to be clarified as if recovered completely or with lasting effects, when queried patient, he reported that he did not notice any problems after that, did not have the pain at the injection site of left arm after that day or two. Time the Vaccination was given was reported as about 17:00. Event not resulted to Emergency Room and Physician Office. Patient was not hospitalized. Regarding concomitant products and other medical conditions caller reported that there is no relevant information to provide for this report. He reported being told that the medications he takes do not effect anything, not relevant.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Laryngitis, Nasopharyngitis, SARS-CoV-2 test, Sinusitis
Clinical narrative: experienced colds.; sinus infection; laryngitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Batch/Lot number: unknown) as dose1, 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 "experienced colds."; SINUSITIS (non-serious), outcome "unknown", described as "sinus infection"; LARYNGITIS (non-serious), outcome "unknown", described as "laryngitis". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: She was scheduled to get the 2nd one on 10 Apr 2021. She started experiencing symptoms 3 days ago; she states she has a cold or a sinus infection, she has no fever, but has a cough, sore throat and runny nose, tested negative for covid, laryngitis. She does not believe it is related to the vaccine as she knows it comes from her husband who had a cold 3 weeks ago and also tested negative for covid. Caller would like to know whether the 2nd dose will be effective if she currently has a cold or a sinus infection. Caller took the 1st dose March 20Apr2021 and has experienced colds. She took the covid exam which came out negative. Caller wants to know if she can proceed to take the 2nd dose on 10Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: her patient got the Pfizer shot, got sick/ her patient got the Pfizer shot, got sick; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558). Other Case identifier(s): US-PFIZER INC-2021386008 (Pfizer).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "her patient got the Pfizer shot, got sick/ her patient got the Pfizer shot, got sick".  Additional information: It was reported that patient already got the 1st dose and had illness. Reporter asked if she needs to restart administering the vaccine or go ahead to give the 2nddose or should make it 3 doses instead. Came down with an illness and they are just now getting over it, so that's probably been more than 42 days. Reporter stated, "So I have a patient that had a Pfizer COVID shot and then before they could get the second one they came down with an illness (Clarification unknown) and they are just now getting over it, so that's probably been more than 42 days, so my question is do they have to restart the whole process or do they just give the second one as soon as they are well enough." When informed about Pfizer Medical Information department, reporter stated, "Is it So I thought that is where I was getting transferred to an hour a half ago, you don't have any answer for me or any other thing than that other than that I might wait for somebody else." Upon Follow-up she said that her patient got the Pfizer shot, got sick and it's now more than 42 days after the first dose. Can he take second dose. Does he need more doses.  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-2021391027 similar report from same reporter
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Groin pain
Clinical narrative: back pain; Inguinal pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An elderly male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 17Mar2021 10:00 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "CVD and other" (unspecified if ongoing), notes: CVD and other. The patient's concomitant medications were not reported.  The following information was reported: BACK PAIN (non-serious) with onset 17Mar2021 10:00, outcome "not recovered", described as "back pain"; GROIN PAIN (non-serious) with onset 17Mar2021 10:00, outcome "not recovered", described as "Inguinal pain". The events "back pain" and "inguinal pain" were evaluated at the physician office visit. Therapeutic measures were taken as a result of back pain, groin pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medication (prescribed for heart) within 2 weeks of 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: Dizziness, Vertigo
Clinical narrative: 2nd one (17Mar2021), I had vertigo and dizziness again; 2nd one (17MAR2021), I had vertigo and dizziness again; 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), administered in arm left, administration date 17Mar2021 (Lot number: EN6204) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Batch/lot number: EN6702), administration date: 21Feb2021, for COVID-19 Immunization, reaction(s): "on my 1st Pfizer vaccine. (21Feb2021) I would report, within couple of days I had dizziness". The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "2nd one (17Mar2021), I had vertigo and dizziness again"; VERTIGO (non-serious), outcome "unknown", described as "2nd one (17MAR2021), I had vertigo and dizziness again". Additional information: The patient reported that it may be every 3 days in the morning and once in a while in the afternoon. Patient continued to get dizzy even after couple of weeks but just really less and it is only in the morning sometime.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache
Clinical narrative: residual headache; felt about 50% of his usual self; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 31Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "suspected COVID-19", start date: Mar2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (1st dose), for COVID-19 immunisation. The following information was reported: FEELING ABNORMAL (non-serious) with onset 01Apr2021, outcome "recovering", described as "felt about 50% of his usual self"; HEADACHE (non-serious) with onset 02Apr2021, outcome "recovering", described as "residual headache".   Additional information: The patient was 50 (unit not reported).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; 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), administered in arm left, administration date 21Feb2021 (Lot number: EN6702) 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: DIZZINESS (non-serious), outcome "unknown", described as "dizziness". Additional information: Within couple of days after the patient's 1st Pfizer vaccine, she had dizziness. It was off and on, most days especially in the morning.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: nausea, vomiting, and diarrhea about 36 hours after vaccination; nausea, vomiting, and diarrhea about 36 hours after vaccination; nausea, vomiting, and diarrhea about 36 hours after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 09:00 (Lot number: EP7534) at the age of 48 years as 1st dose, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DIARRHOEA (non-serious), NAUSEA (non-serious), VOMITING (non-serious) all with onset 06Apr2021 19:00, outcome "recovering" and all described as "nausea, vomiting, and diarrhea about 36 hours after vaccination".  Additional information: No treatment received, no covid prior to vaccination, no covid tested post vaccination, no allergies, no other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: threw up heavy/ vomited; Heavy diarrhea; 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 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date Mar2021 (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: VOMITING (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "threw up heavy/ vomited"; DIARRHOEA (non-serious) with onset Mar2021, outcome "unknown", described as "Heavy diarrhea". Additional information: Events were reported to occur 2 days after the initial BNT162B2 vaccination. Heavy vomiting lasted 2 days.  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 mass
Clinical narrative: her right hand has two big lumps after getting the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Apr2021 (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 MASS (non-serious), outcome "unknown", described as "her right hand has two big lumps after getting the vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "colon cancer surgery" (unspecified if ongoing), notes: she had a colon cancer surgery a month ago before she took the 1st dose. The patient's concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset 07Apr2021, outcome "unknown", described as "diarrhea".  Additional information: Patient was due to take her 2nd dose of vaccine today 07Apr2021 at 2:30 pm and was having some diarrhea this morning (07Apr2021). She wanted to take an antidiarrheal medication, loperamide (IMODIUM) prior to receiving the 2nd dose vaccine and was asking if it was okay/safe.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Vaccination site erythema
Clinical narrative: got a ring in the same arm were she received the shot. It is on the wrist by the thumb. It is raised, squishy red mark; got a ring in the same arm were she received the shot. It is on the wrist by the thumb. It is raised, squishy red mark; 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 34 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 06Apr2021 10:30 (Lot number: ER8734) at the age of 34 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), RASH PAPULAR (non-serious) all with onset 06Apr2021, outcome "not recovered" and all described as "got a ring in the same arm were she received the shot. It is on the wrist by the thumb. It is raised, squishy red mark". Therapeutic measures were taken as a result of vaccination site erythema, rash papular.  Additional information: The patient got a ring in the same arm were she received the shot. It was on the wrist by the thumb. It was raised, squishy red mark/ on the same arm that she received the vaccine, down by her wrist, on the side of her thumb, the vein was raised and has a red line over it. It did not hurt. Clarified that it was the vein was on the side of her thumb, wrist area. The vein was raised but the vein was not hard, it was squishy, and had a red line over it. She was concerned because this has not gone away. Last night, she spoke with a friend who was a doctor. The doctor told her to put ice on it, and then wrap it with an ace bandage. But it was still here today.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Movement disorder, Muscle disorder, Muscle spasms, Oxygen saturation, Vaccination site pain
Clinical narrative: severe muscle cramping; pain on the site that he have the injection; his neck he also having the hard time moving; muscle issue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 68 year-old male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Lot number: EN8732) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes type 1" (unspecified if ongoing); "Type 2 insulin dependent" (unspecified if ongoing); "Multiple sclerosis (MS)" (unspecified if ongoing); "allergic reaction: Gadolinium a contrast dye(Suspect captured)" (unspecified if ongoing); "allergic to peanut butter" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Lot Number: EN6206), for Covid-19 immunisation. The following information was reported: MUSCLE SPASMS (non-serious), outcome "unknown", described as "severe muscle cramping"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain on the site that he have the injection"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "his neck he also having the hard time moving"; MUSCLE DISORDER (non-serious), outcome "unknown", described as "muscle issue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter called on behalf of her husband who was sitting in waiting area right now, he had the second dose of vaccine yesterday (31Mar2021), and she was trying to determine whether or not having an adverse reaction and should get seek medical attention. He was getting some severe muscle cramping as well as not aches but pain on the site that he have the injection, and his neck he also having the hard time moving but again he did have a muscle issue to begin with so right now he respiration seems to be fine, his oxygen level seem to be fine he has had have allergic reaction on the past to other things such as Gadolinium a contrast dye(Suspect captured) also we find out he is allergic to peanut butter.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash morbilliform
Clinical narrative: measle like rash primarily on arms and legs; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 20Mar2021 09:00 (Lot number: EN6207) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy to vaccine" (unspecified if ongoing), notes: Zoster vaccine; "AB+ platelets allergy" (unspecified if ongoing), notes: AB+ platelets allergy; "contrast dye allergy" (unspecified if ongoing), notes: contrast dye allergy; "COPD" (unspecified if ongoing); "Invasive bladder cancer stage IV" (unspecified if ongoing), notes: Stage 4 Invasive Bladder Cancer with mets to liver survivor.; "Hypothyroidism" (unspecified if ongoing), notes: low thyroid; "Potassium low" (unspecified if ongoing), notes: low potassium; "heart" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Zoster shingle shot (I had a similar reaction to Zoster Shingle shot 19Jul2014 that lasted over 44 days when I reported to Merck), administration date: 19Jul2014, reaction(s): "similar reaction"; BNT162B2 (Dose 1, Single, Lot number: EN6203, Administration Site: Arm Left, Administered time: 09:15, The 1st shot only had the red mark on arm with injection that lasted 4 days.), administration date: 24Feb2021, when the patient was 74 years old, for COVID-19 immunisation, reaction(s): "red mark on arm with injection". The following information was reported: RASH MORBILLIFORM (non-serious) with onset 22Mar2021, outcome "not recovered", described as "measle like rash primarily on arms and legs". Therapeutic measures were not taken as a result of rash morbilliform.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had taken unspecified medications within 2 weeks of vaccination. The patient had not been diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 since the vaccination. On 22Mar2021, the patient had experienced measles like rash primarily on arms and legs, started 2 days after injection and still happening. The patient did not receive any treatment for the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021388043 same patient, same drug, different AE, different dose of vaccine.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Oropharyngeal pain, Pain
Clinical narrative: swollen glands; sore throat; body aches; headache; arm sore; very tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 11Mar2021 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (ongoing); "sensitive to medications and has to take the "child dose" of most OTC medications" (ongoing). The patient took concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 11Mar2021, outcome "not recovered", described as "swollen glands"; OROPHARYNGEAL PAIN (non-serious) with onset 11Mar2021, outcome "not recovered", described as "sore throat"; PAIN (non-serious) with onset 11Mar2021, outcome "not recovered", described as "body aches"; HEADACHE (non-serious) with onset 11Mar2021, outcome "not recovered", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 11Mar2021, outcome "not recovered", described as "arm sore"; FATIGUE (non-serious) with onset 11Mar2021, outcome "not recovered", described as "very tired". Additional information: The events were reported as mild and ongoing. The patient was concomitantly taking unspecified antihistamine for seasonal allergies. Dose 2 was scheduled on 08Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: swollen glands; sore throat; body aches; headache; arm sore; very tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 11Mar2021 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (ongoing); "sensitive to medications and has to take the "child dose" of most OTC medications" (ongoing). The patient took concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 11Mar2021, outcome "not recovered", described as "swollen glands"; OROPHARYNGEAL PAIN (non-serious) with onset 11Mar2021, outcome "not recovered", described as "sore throat"; PAIN (non-serious) with onset 11Mar2021, outcome "not recovered", described as "body aches"; HEADACHE (non-serious) with onset 11Mar2021, outcome "not recovered", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 11Mar2021, outcome "not recovered", described as "arm sore"; FATIGUE (non-serious) with onset 11Mar2021, outcome "not recovered", described as "very tired". Additional information: The events were reported as mild and ongoing. The patient was concomitantly taking unspecified antihistamine for seasonal allergies. Dose 2 was scheduled on 08Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Migraine, SARS-CoV-2 test
Clinical narrative: Migraine; Chills; Fatigue; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 41 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 01Mar2021 10:00 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunization. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination; "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious) with onset 01Mar2021 11:00, outcome "recovered with sequelae" (2021), described as "Migraine"; CHILLS (non-serious) with onset 01Mar2021 11:00, outcome "recovered with sequelae" (2021), described as "Chills"; FATIGUE (non-serious) with onset 01Mar2021 11:00, outcome "recovered with sequelae" (2021), described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of migraine, chills and fatigue.  Additional information: Patient had been diagnosed with COVID-19 prior to vaccination. On 01Mar2021 at 11:00, the patient experienced migraine, chills and fatigue and had to go home from work early. The patient was out of work for two days with symptoms. On 11Mar2021 and 01Apr2021, the patient underwent COVID-19 test, and the results were both negative. The patient had not received any other vaccine within 4 weeks. The patient was not allergic to any medications, food or other products.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise
Clinical narrative: felt sick, nostalgic, and she can barely take her home; felt sick, nostalgic, and she can barely take her home; This is a spontaneous report received from a contactable consumer from medical information team.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID 19 vaccine (dose 1, Batch/Lot number: unknown), for COVID-19 immunisation. The following information was reported: MALAISE (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "felt sick, nostalgic, and she can barely take her home".  Additional information: Patient's age was reported to be between 50s-70s.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: twitching in leg has increased; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Leukemia" (unspecified if ongoing); "stem cell transplant" (unspecified if ongoing); "twitching and intense leg cramps" (unspecified if ongoing); "twitching and intense leg cramps" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 02Apr2021, outcome "unknown", described as "twitching in leg has increased".  Additional information: Patient had Leukemia and stem cell transplant and has twitching and intense leg cramps. Had first covid shot  already, second one coming up tomorrow. After first shot, the twitching in leg has increased. Cautions about taking second covid shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: fell; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 17Mar2021 (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: FALL (non-serious), outcome "unknown", described as "fell". Additional information: The reporter wanted to know if her mother (patient) can reschedule her second dose appointment a month later.  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: Abdominal pain, Vomiting
Clinical narrative: Abdominal cramping; vomiting; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 09Mar2021 08:45 (Lot number: EN6205) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing). Concomitant medication included: SANDOSTATIN LAR DEPOT. Past drug history included: Ibuprofen, reaction: "Drug allergy"; Vicodin, reaction: "Drug allergy". Vaccination history included: bnt162b2 (Dose 1, single (Lot Number: EN6200), in the left arm at 08:45), administration date: 16Feb2021, when the patient was 70 years old, for COVID-19 immunisation. The following information was reported: ABDOMINAL PAIN (non-serious) with onset 09Mar2021 20:00, outcome "recovered with sequelae" (2021), described as "Abdominal cramping"; VOMITING (non-serious) with onset 09Mar2021 20:00, outcome "recovered with sequelae" (2021), described as "vomiting". Therapeutic measures were not taken as a result of abdominal pain, vomiting.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 09Mar2021 at 20:00, the patient reported that she experienced similar reaction which she had with octreotide each month which included abdominal cramping and vomiting. It was not as severe and only vomited once and lasted only evening and early morning. She also reported that her next reaction to octreotide lasted longer in hours then sick for six days. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sharp pain on the bottom of his foot said it feels like he stepped on a nail; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sharp pain on the bottom of his foot said it feels like he stepped on a nail".  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 vesicles
Clinical narrative: had two pimples with what appeared to her as "having water in them" at her injection site; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 05Apr2021 (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 VESICLES (non-serious), outcome "unknown", described as "had two pimples with what appeared to her as "having water in them" at her injection site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Got the 2nd shot of the vaccine three months after the 1st dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (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: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Got the 2nd shot of the vaccine three months after the 1st dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache
Clinical narrative: residual headache; felt about 50% of his usual self; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: Mar2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for Covid-19 immunisation, reaction(s): "No side effects". The following information was reported: FEELING ABNORMAL (non-serious) with onset 01Apr2021, outcome "unknown", described as "felt about 50% of his usual self"; HEADACHE (non-serious) with onset 02Apr2021, outcome "unknown", described as "residual headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Food poisoning, Malaise, Vomiting
Clinical narrative: Felt sick; I threw up yesterday; food poisoning; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (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 2021, outcome "unknown", described as "Felt sick"; VOMITING (non-serious) with onset 2021, outcome "unknown", described as "I threw up yesterday"; FOOD POISONING (non-serious) with onset 2021, outcome "unknown", described as "food poisoning".  Additional Information: The patient was asking if what's the longest interval between doses and if one can receive the Pfizer second dose outside of the 21 days interval. The patient also asked if she can receive the second dose if tested positive for COVID after receiving the first dose of the Pfizer COVID-19 vaccine. She heard that if someone tested positive, they can get vaccine if they let them in the building. The patient stated that she had her first shot of the Pfizer vaccine and felt sick in between. She threw up yesterday (2021). She thought that it's food poisoning. She was asking if she can get the second dose. Her doctor was not helping or proving any kind of information to her. He referred her back to Pfizer. She was scheduled to receive the second dose 18 days after dose 1.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Dizziness, Fatigue, Feeling abnormal, Hyperhidrosis
Clinical narrative: Nausea; Fatigue; feels like she has some type of cold; bloated; tired; foggy; lots of sweating; Dizziness; sweating a lot; she doesn't feel 100%; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 21 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 (Lot number: EW0150, Expiration Date: 31Jul2021) at the age of 21 years as dose 1,single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 07Apr2021, outcome "not recovered", described as "Nausea"; DIZZINESS (non-serious) with onset 06Apr2021, outcome "not recovered", described as "Dizziness"; FATIGUE (non-serious) with onset 07Apr2021, outcome "not recovered", described as "Fatigue"; HYPERHIDROSIS (non-serious) with onset 06Apr2021, outcome "not recovered", described as "lots of sweating"; NASOPHARYNGITIS (non-serious) with onset 07Apr2021, outcome "unknown", described as "feels like she has some type of cold"; FEELING ABNORMAL (non-serious) with onset Apr2021, outcome "unknown", described as "she doesn't feel 100%"; FEELING ABNORMAL (non-serious) with onset 06Apr2021, outcome "unknown", described as "foggy"; HYPERHIDROSIS (non-serious) with onset Apr2021, outcome "unknown", described as "sweating a lot"; ABDOMINAL DISTENSION (non-serious) with onset 07Apr2021, outcome "unknown", described as "bloated"; FATIGUE (non-serious) with onset 06Apr2021, outcome "unknown", described as "tired".  Additional information:Patient had a question about symptoms of the first dose. she has heard after the second dose the symptoms are pretty severe but mine are bad with the first dose. Is it normal? Her first dose was on Monday the 5 th and yesterday she was pretty standard foggy and tired. Today she has intense nausea, bloated and I feel like I have a cold and foggy head. The caller is calling about the Pfizer covid vaccine. The caller is curious because she has been talking to other people and they said the second dose had the worse side effects and no effects on the first dose. The caller has experienced symptoms after the first dose and didn't know if this could happen. The caller has had lots of nausea, dizziness, fatigue, lots of sweating, feels like she has some type of cold, and she doesn't feel 100%. The symptoms are moderate, it's nothing super super bad. The caller has been doing a lot of physical activity and she has been sweating more than usual during it and at night time. Patient had a scheduled appointment for a second dose due on 26Apr2021. Asked if the second dose has the worst side effects.Did reporter consent to further follow-up: unknown.Did the patient/consumer/ caregiver provide consent to contact the prescribing HCP: Unknown.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Nausea
Clinical narrative: Nausea; Fatigue; feels like she has some type of cold; bloated; tired; foggy; lots of sweating; Dizziness; sweating a lot; she doesn't feel 100%; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 21 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 (Lot number: EW0150, Expiration Date: 31Jul2021) at the age of 21 years as dose 1,single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 07Apr2021, outcome "not recovered", described as "Nausea"; DIZZINESS (non-serious) with onset 06Apr2021, outcome "not recovered", described as "Dizziness"; FATIGUE (non-serious) with onset 07Apr2021, outcome "not recovered", described as "Fatigue"; HYPERHIDROSIS (non-serious) with onset 06Apr2021, outcome "not recovered", described as "lots of sweating"; NASOPHARYNGITIS (non-serious) with onset 07Apr2021, outcome "unknown", described as "feels like she has some type of cold"; FEELING ABNORMAL (non-serious) with onset Apr2021, outcome "unknown", described as "she doesn't feel 100%"; FEELING ABNORMAL (non-serious) with onset 06Apr2021, outcome "unknown", described as "foggy"; HYPERHIDROSIS (non-serious) with onset Apr2021, outcome "unknown", described as "sweating a lot"; ABDOMINAL DISTENSION (non-serious) with onset 07Apr2021, outcome "unknown", described as "bloated"; FATIGUE (non-serious) with onset 06Apr2021, outcome "unknown", described as "tired".  Additional information:Patient had a question about symptoms of the first dose. she has heard after the second dose the symptoms are pretty severe but mine are bad with the first dose. Is it normal? Her first dose was on Monday the 5 th and yesterday she was pretty standard foggy and tired. Today she has intense nausea, bloated and I feel like I have a cold and foggy head. The caller is calling about the Pfizer covid vaccine. The caller is curious because she has been talking to other people and they said the second dose had the worse side effects and no effects on the first dose. The caller has experienced symptoms after the first dose and didn't know if this could happen. The caller has had lots of nausea, dizziness, fatigue, lots of sweating, feels like she has some type of cold, and she doesn't feel 100%. The symptoms are moderate, it's nothing super super bad. The caller has been doing a lot of physical activity and she has been sweating more than usual during it and at night time. Patient had a scheduled appointment for a second dose due on 26Apr2021. Asked if the second dose has the worst side effects.Did reporter consent to further follow-up: unknown.Did the patient/consumer/ caregiver provide consent to contact the prescribing HCP: Unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable reporter(s) (Consumer) from medical information team for a Pfizer sponsored program (159558).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 01Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Photosensitivity reaction
Clinical narrative: Today he asked me if photosensitivity is an issue. He has been experiencing a noticeable increase for the past 2 days.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) as dose 1 single for covid-19 immunisation. Relevant medical history included: "type 2 diabetic" (unspecified if ongoing); "obese" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PHOTOSENSITIVITY REACTION (non-serious), outcome "unknown", described as "Today he asked me if photosensitivity is an issue. He has been experiencing a noticeable increase for the past 2 days.".  Additional information: He was not suspected to have ever had Covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Pain in extremity
Clinical narrative: Arm pain; Headache; Fatigue; Back pain; 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 55 year-old female patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (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 "Arm pain"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; BACK PAIN (non-serious), outcome "unknown", described as "Back pain".  Additional information: Patient has been experiencing arm pain, headache, fatigue, and back pain for 5 days and is wondering if this is a normal reaction. Patient was concerned about getting the second dose of the vaccine because she is worried about worse side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite
Clinical narrative: made them fell weak and lose their apetite; made them fell weak and lose their apetite; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 67 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization. The following information was reported: ASTHENIA (non-serious), DECREASED APPETITE (non-serious), outcome "unknown" and all described as "made them fell weak and lose their apetite".  Additional information- Patient did not want to take their weekly dose of Ozempic that week.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.