chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Neck pain
Clinical narrative: neck and back pain; neck and back pain; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 09:15 (Lot number: EN6200) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "covid positive", start date: Jan2021 (unspecified if ongoing), notes: covid positive; "Hypertensive" (unspecified if ongoing); "flat feet" (unspecified if ongoing); "obese" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number-1), for Covid-19 immunization. The following information was reported: NECK PAIN (non-serious), BACK PAIN (non-serious) all with onset 25Mar2021 15:00, outcome "not recovered" and all described as "neck and back pain". Therapeutic measures were taken as a result of neck pain, back pain.  Additional information: Patient did not receive any other vaccines within 4weeks prior to the COVID vaccine. No other medication in two weeks. Patient received shot and a couple hours later patient went back to work and worked the next few hours. Later that day and until now patient have had neck and back pain since receiving the second shot. Occasionally in the past patient Gert pain in neck or shoulder blade areas but it goes away in a few days. This pain has stayed with patient since got the injection. Sometimes the pain is somewhat sharp. It is not unbearable, but it is always there. Treatment included applied heat, massages. Prior to vaccination, patient not diagnosed with covid 19. Since the vaccination patient not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, SARS-CoV-2 test
Clinical narrative: Chills; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Apr2021 16:45 (Lot number: ER2613) at the age of 31 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, Administration time=04:45 PM, Lot number = ER2613, vaccine location=Right arm), administration date: 30Mar2021, when the patient was 31 years old, for Covid-19 Immunisation. The following information was reported: CHILLS (non-serious) with onset 21Apr2021 09:00, outcome "recovering", described as "Chills"; HEADACHE (non-serious) with onset 21Apr2021 09:00, outcome "recovering", described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills.  Additional Information: The patient was not tested positive for COVID-19 prior vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The laboratory result included SARS-CoV-2 test was negative on 09Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Nausea
Clinical narrative: gastrointestinal problems; nauseous; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 20-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in arm left, administration date 15Apr2021 13:15 (Batch/Lot number: unknown) at the age of 20 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Gastroparesis" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162B2 (dose 1, administered in the left arm, Batch/Lot number: unknown), administration date: 25Mar2021 13:15, when the patient was 20 years old, for COVID-19 immunisation. The following information was reported: GASTROINTESTINAL DISORDER (non-serious) with onset 17Apr2021, outcome "unknown", described as "gastrointestinal problems"; NAUSEA (non-serious) with onset 17Apr2021, outcome "unknown", described as "nauseous". The events "gastrointestinal problems" and "nauseous" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of gastrointestinal disorder, nausea.  Additional information: The patient and her mom (50) got both of their vaccines at the same time/place. With their second dose, they had normal side effects (not further specified) that went away after two days, but they've had gastrointestinal problems since, going on two weeks now. They're both nauseous and eating anything beside the BRAT diet made them feel even worse.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jan2021 (Lot number: FL3247) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "little ball/lump/mass in collar bone area" (ongoing), notes: at least 2-3 years before, but it never hurt. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient was concomitantly taking unspecified birth control medications.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Injected limb mobility decreased, SARS-CoV-2 antibody test, Streptococcus test
Clinical narrative: I was very tired; Couldn't move arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 25Jan2021 09:40 (Lot number: EL9261) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Presumed COVID-19", start date: 05Jan2021 (unspecified if ongoing), notes: Asymptomatic, no symptoms, Fever, Slight Headache, Chills, Vomiting's during time period. There were no concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "I was very tired"; INJECTED LIMB MOBILITY DECREASED (non-serious), outcome "unknown", described as "Couldn't move arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: On 02Jul2020, the patient been tested negative for Covid Antibody Test. On 02Feb-10Feb abnormally ill with Covid like symptoms, followed up with antibody test was negative, also negative for Strep's flu. The patient presumed that asymptomatic Covid 19 had on 05Jan2021. No symptoms/fever slight headache, chills, vomiting's during time period were reported. On 13Feb2021, the patient had Covid symptoms. No Covid testing was available at that time I took an antibody test 02Jul2020 but later became aware time with accuracy of the test was low. The patient's spouse tested positive for Covid on 05Jan2021. The patient was slightly symptomatic (Chills, Vomiting, Headache) and took shot 1 on 25Jan2021 and shot 2 on 18Feb2021, Couldn't move arm after shot 1 and was very tired, after shot 2, the patient had every symptom on the Pfizer info sheet except for injection site redness, was very ill about 3 days. The vaccination facility was provided as hospital and not administered at military facility. The patient did not received any medication and concomitant medication within 4 weeks prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: 1st dose: Bitter taste in back of throat for half day on date of administration; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Apr2021 09:30 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimoto" (unspecified if ongoing); "known_allergies: Sulfur based antibiotics" (unspecified if ongoing), notes: Sulfur based antibiotics. Concomitant medication(s) included: MULTIVITAMINS [VITAMINS NOS]. The following information was reported: DYSGEUSIA (non-serious) with onset 03Apr2021, outcome "recovering", described as "1st dose: Bitter taste in back of throat for half day on date of administration". Therapeutic measures were taken as a result of dysgeusia.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination except Multi vitamins, collagen peptide powder. Prior to vaccination, the patient was not diagnosed with COVID 19, since the vaccination, the patient had not been tested for COVID 19. Treatment included alternated Advil and Tylenol. The case was reported as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Stepped in a hole, she did not fall, but now the bottom of her foot hurts.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 16Apr2021 (Lot number: Not Provided) 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), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Stepped in a hole, she did not fall, but now the bottom of her foot hurts.".   Additional information: She reports her dog Fraya, a large dog or granddaughter may have dug a hole. She reports she stepped in the hole while she was walking in her back yard to check on her tomatoes, she did not fall. She doesn't know what happened, if she bruised or pulled muscle in the bottom of her foot but, it hurts. She can't see it because its the bottom of her foot. It has been a little over a week since she had her last COVID vaccine and wants to know if it is safe to take something over the counter specifically, Ibuprofen, since she was previously told not to take it.  She states she spoke to the hospital where she got the vaccine but, got no answer and a pharmacist but, again, got no answer. Caller does not think that she falling in or stepping in a hole has anything to do with getting the COVID vaccine. She reports everything with her COVID vaccines went a lot easier than she expected it to. Caller reports that she understands now why she did not get an answer to her question and does not need to be transferred because she has her answer. She states her answer came from the Regional Pharmacy Director she happens to know at the hospital she use to work for, it's all politics. She is not sure if the call-handler worked in a hospital before but, it is all politics. Its a long story doesn't its all related to politics especially if your non-clinical like she was. She now understands where the directive of no Ibuprofen comes from. She feels that she has answered her own question and does not want to continue on 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: Pain
Clinical narrative: "Some soreness" after Vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as ""Some soreness" after Vaccination".  Additional information: Reporter did not consider event as caused by suspect product(s)  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-2021466838 same product/event, different patients
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: "Some soreness" after Vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (160354).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown  single dose 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 ""Some soreness" after Vaccination".  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-2021466770 same product/event, different patients
Sex: F
Vaccine: COVID19
Symptoms: Arthropod sting
Clinical narrative: spread like a bee sting; This is a spontaneous report received from a contactable reporter (Consumer).  A female patient received BNT162B2 (BNT162B2) (Lot number: Not Provided) 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: ARTHROPOD STING (non-serious), outcome "unknown", described as "spread like a bee sting". Additional Information: The patient stated kind of spread like a bee sting, if this get any bigger she was gonna have to name it.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021459675 same reporter/drug, different patient/event;US-PFIZER INC-2021459554 same reporter/drug, different patient/event
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Off label use, Paraesthesia, Product use issue
Clinical narrative: Facial numbness; Tingling on the right side; "I am breastfeeding"; "I am breastfeeding"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Apr2021 (Batch/Lot number: unknown) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Loss of control of legs" (unspecified if ongoing), notes: experienced numbness and loss of ability to move my legs during an epidural with my first child.; "Breast feeding" (ongoing); "Numbness" (unspecified if ongoing), notes: experienced numbness and loss of ability to move my legs during an epidural with my first child. Concomitant medication(s) included: FLUTICASONE PROPIONATE. The following information was reported: HYPOAESTHESIA (non-serious) with onset 18Apr2021 13:15, outcome "not recovered", described as "Facial numbness"; PARAESTHESIA (non-serious) with onset 18Apr2021 13:15, outcome "not recovered", described as "Tingling on the right side"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 18Apr2021, outcome "unknown" and all described as ""I am breastfeeding"". Therapeutic measures were not taken as a result of hypoaesthesia, paraesthesia.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101154267 mother/baby case
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), (Age at Vaccination  : 32 years) administered in arm left, administration date 23Mar2021 10:30 (Lot number: ER8730) at the age of 32 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Sore arm at injection site".  Additional information : No Covid prior to vaccination. No covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: More tired than normal; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 12Apr2021 (Batch/Lot number: unknown) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid vaccine (Dose number:1), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "More tired than normal".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: have no side effects as of 0334 the next morning besides injection site discomfort.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 21Apr2021 16:00 (Batch/Lot number: unknown) at the age of 25 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]; CALCIUM. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, Administrator route=Intramuscular,, Vaccine location=Left arm,, Dose number=1), administration date: 30Mar2021, for Covid 19 immunisation. The following information was reported: VACCINATION SITE DISCOMFORT (non-serious) with onset 22Apr2021 02:00, outcome "unknown", described as "have no side effects as of 0334 the next morning besides injection site discomfort.". Therapeutic measures were not taken as a result of vaccination site discomfort.  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-2021446816 same reporter/drug, different patient and event.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: felt constantly dizzy, the dizziness gets bad; 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) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: unknown), for covid-19 immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "felt constantly dizzy, the dizziness gets bad".  Additional information: Caller reported that a friend of hers, 2 weeks after the second vaccine felt constantly dizzy, the dizziness got bad, she had all kinds of test runs.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I had some arm pain; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  A female patient in her 80's 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 "I had some arm pain".  Additional information: It was reported that, after the patient got her Pfizer one, she had some arm pain and stuff and stated that, they felt a little, patient's were well and they were like really. The causality of the event was reported as related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: slightly sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Mar2021 12:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ulcerative Collitus" (unspecified if ongoing); "anemia" (unspecified if ongoing); "obesity" (unspecified if ongoing); "exercise-induced asthma" (unspecified if ongoing). Concomitant medication(s) included: XANAX; OMEPRAZOLE; ALPRAZOLAM; FLUOXETINE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "not recovered", described as "slightly sore arm". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: That is my supercharged out to kill anything that comes near me, overreactive immune system going to be; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  An adult 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: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "That is my supercharged out to kill anything that comes near me, overreactive immune system going to be".  Additional Information: Batch/Lot number unknown. The patient's relevant medical history and concomitant medications were not reported. Causality: Related. I just want to wait and see because I saw people who flew through, you know, the flu vaccine, hadn't had a problem with their Hep B series. They got this vaccine and the immune response that it generated was pretty profound. And they were pretty, like, knocked down.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An adult 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: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: Age/Date of birth was reported as 80-84 years.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes near collar bone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  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: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes near collar bone".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Vomiting
Clinical narrative: Extreme nausea and vomiting in AM of the second day followed by two days of heavy tiredness.; Extreme nausea and vomiting in AM of the second day followed by two days of heavy tiredness.; Extreme nausea and vomiting in AM of the second day followed by two days of heavy tiredness.; Dull but pinging headache approx 5-6hrs after vaccine injection & most of the second day.; This is a spontaneous report received from a contactable Consumer (patient herself).  A 35-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 23Apr2021 12:45 (Lot number: EW0151) at the age of 35 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Attention deficit disorder" (unspecified if ongoing). Concomitant medication included: amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); colecalciferol, menaquinone (VITAMINE K2+D3); ethinylestradiol, ferrous fumarate, norethisterone acetate (LARIN FE 1/20). The following information was reported: FATIGUE (non-serious), NAUSEA (non-serious), VOMITING (non-serious) all with onset 24Apr2021, outcome "recovered" and all described as "Extreme nausea and vomiting in AM of the second day followed by two days of heavy tiredness."; HEADACHE (non-serious) with onset 23Apr2021 17:00, outcome "recovered", described as "Dull but pinging headache approx 5-6hrs after vaccine injection & most of the second day.". Therapeutic measures were not taken as a result of fatigue, nausea, vomiting, headache. No follow-up attempts are possible. No further information is expected. Additional information: No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine Pre-vaccination and post-vaccination COVID tests were not performed.  No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Cardiac stress test, Delusional disorder, unspecified type, Echocardiogram, Pain in extremity
Clinical narrative: His leg has been burning and aching/Legs started to burn and ache after second vaccine; His leg has been burning and aching/Legs started to burn and ache after second vaccine; Sleep problems after second vaccine; he got delusional at night.; 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 76 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 (Lot number: EW0162, Expiration Date: 31Jul2021) at the age of 76 years as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Verbatim: high blood pressure" (unspecified if ongoing); "Covid long haulers" (unspecified if ongoing), notes: The first vaccine took away some of his long-haulers symptoms. Concomitant medication(s) included: OLMESAR taken for hypertension; AMLODIPINE BESILATE taken for hypertension. Vaccination history included: Bnt162b2 (First vaccine: Pfizer Bio-NTech COVID19 Vaccine, 0.3 mL.  LOT number which the internet would not let him fill in to report online is ER8727 and expiration 31Jul2021.), administration date: 19Mar2021, for COVID-19 Immunization. The following information was reported: BURNING SENSATION (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "His leg has been burning and aching/Legs started to burn and ache after second vaccine"; SLEEP DISORDER (non-serious), outcome "unknown", described as "Sleep problems after second vaccine"; DELUSIONAL DISORDER, UNSPECIFIED TYPE (non-serious), outcome "unknown", described as "he got delusional at night.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: He reports taking his first Pfizer Covid vaccine dose on 19Mar2021 and his second Pfizer Covid vaccine dose on 09Apr2021. On 11Apr2021 he reports that his leg has been burning and aching. He reports having a history of Covid long haulers. Caller states he is calling about the Pfizer Covid-19 Vaccine because he got the shot 2 weeks ago last Friday. He had Covid once in August and once again in December. Then, he waited 90 days after December after he tested negative. Patient description, he would go to sleep and sleep an hour and then would wake up and would count jellybeans. Caller adds he is lying, and means he would count 1 to 10, and 1 to 10, for the next 7 hours. Caller adds that the second vaccine gave him this same symptom. It was very, very bad the first night and he only slept for one hour. The second night, it was very very slight. Then, by the end of the second day he had leg pains but no more sleep problems. Tylenol and extra strength arthritic tylenol were taken as treatment, no other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sleep disorder
Clinical narrative: His leg has been burning and aching/Legs started to burn and ache after second vaccine; His leg has been burning and aching/Legs started to burn and ache after second vaccine; Sleep problems after second vaccine; he got delusional at night.; 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 76 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 (Lot number: EW0162, Expiration Date: 31Jul2021) at the age of 76 years as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Verbatim: high blood pressure" (unspecified if ongoing); "Covid long haulers" (unspecified if ongoing), notes: The first vaccine took away some of his long-haulers symptoms. Concomitant medication(s) included: OLMESAR taken for hypertension; AMLODIPINE BESILATE taken for hypertension. Vaccination history included: Bnt162b2 (First vaccine: Pfizer Bio-NTech COVID19 Vaccine, 0.3 mL.  LOT number which the internet would not let him fill in to report online is ER8727 and expiration 31Jul2021.), administration date: 19Mar2021, for COVID-19 Immunization. The following information was reported: BURNING SENSATION (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "His leg has been burning and aching/Legs started to burn and ache after second vaccine"; SLEEP DISORDER (non-serious), outcome "unknown", described as "Sleep problems after second vaccine"; DELUSIONAL DISORDER, UNSPECIFIED TYPE (non-serious), outcome "unknown", described as "he got delusional at night.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: He reports taking his first Pfizer Covid vaccine dose on 19Mar2021 and his second Pfizer Covid vaccine dose on 09Apr2021. On 11Apr2021 he reports that his leg has been burning and aching. He reports having a history of Covid long haulers. Caller states he is calling about the Pfizer Covid-19 Vaccine because he got the shot 2 weeks ago last Friday. He had Covid once in August and once again in December. Then, he waited 90 days after December after he tested negative. Patient description, he would go to sleep and sleep an hour and then would wake up and would count jellybeans. Caller adds he is lying, and means he would count 1 to 10, and 1 to 10, for the next 7 hours. Caller adds that the second vaccine gave him this same symptom. It was very, very bad the first night and he only slept for one hour. The second night, it was very very slight. Then, by the end of the second day he had leg pains but no more sleep problems. Tylenol and extra strength arthritic tylenol were taken as treatment, no other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment, Tenderness
Clinical narrative: little bit more forgetful; little tenderness at the side; This is a spontaneous report received from contactable reporter(s) (Other HCP and Physician).  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: MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "little bit more forgetful"; TENDERNESS (non-serious), outcome "unknown", described as "little tenderness at the side".  Additional information: doctor said his father had a little, just little tenderness at the side. He think he was, might've been a little bit more forgetful that day. But that's his usual.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea
Clinical narrative: nauseous; sick; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "stroke" (unspecified if ongoing), notes: my daughter [NAME OTHER], the one that had the stroke. The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "nauseous"; ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional Information: Causal relationship between BNT162B2 and  events of nausea and illness  was related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Skin mass
Clinical narrative: had a little goose egg here; sore arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adult 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: SKIN MASS (non-serious), outcome "unknown", described as "had a little goose egg here"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional Information: Causality was reported related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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 "got sick". Reported verbatim: But, uh, you know, I accept that that's going to happen. But, you know, I have not seen anybody, they have, like, started to pull weird stuff that have happened three weeks later, there is like a, an, uh, obstetrician who had some blood platelet thing and they are trying to figure it out. But they are not really sure if it is related. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Movement disorder
Clinical narrative: he couldn't walk upstairs; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  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: MOVEMENT DISORDER (non-serious), outcome "unknown", described as "he couldn't walk upstairs".  Additional information: Causality: Related, All adverse events must be reported to the relevant Drug Safety Group within 24 hours of awareness.  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: got really sick; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "they both had had COVID before" (unspecified if ongoing), notes: they both had had COVID before. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got really sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain
Clinical narrative: Upon receiving his second shot, he also experienced fatigue and reportedly felt awful 22Apr2021 with his whole body aching.; Upon receiving his second shot, he also experienced fatigue and reportedly felt awful 22Apr2021 with his whole body aching.; body aching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 51 year-old male patient received bnt162b2 (BNT162B2), administration date 21Apr2021 (Lot number: EW0172) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, lot number=ER2613,, lot unknown=False,, administration date=27Mar2021,, dose number=1), administration date: 27Mar2021, when the patient was 51 years old, for Covid-19 immunisation, reaction(s): "joint pain". The following information was reported: FATIGUE (non-serious), MALAISE (non-serious) all with onset 22Apr2021, outcome "unknown" and all described as "Upon receiving his second shot, he also experienced fatigue and reportedly felt awful 22Apr2021 with his whole body aching."; PAIN (non-serious) with onset 22Apr2021, outcome "unknown", described as "body aching". Therapeutic measures were not taken as a result of fatigue, malaise, pain.  Additional information: No other vaccine in four weeks. On 21Apr2021, (name withheld) reported to me (name withheld) that he has had joint pain since his first shot 27Mar2021. Upon receiving his second shot, he also experienced fatigue and reportedly felt awful 22Apr2021 with his whole body aching. I believe he got vaccinated in left arm but unsure.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Ovulation pain
Clinical narrative: Painful double ovulation after second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Apr2021 (Lot number: Ew0161) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Neomycin, reaction(s): "Allergies: neomycin"; Bacitracin, reaction(s): "Allergies: bacitracin"; Chloraprep, reaction(s): "Allergies: chloraprep". Vaccination history included: Bnt162b2 (Product: COVID-19, Brand PFIZER, Lot number: Er8730, Lot unknown: False, Administration date: 25Mar2021, Administration time: 02:00 PM, Vaccine location: Right Arm, Dose Number: 1), administration date: 25Mar2021, when the patient was 38 years old, for COVID-19 Immunisation, reaction(s): "Increased resting heart rate (increase of 15bpm) Painful", "heavy period after 1st dose with lots of clotting", "heavy period after 1st dose with lots of clotting". The following information was reported: OVULATION PAIN (non-serious) with onset 20Apr2021 15:45, outcome "unknown", described as "Painful double ovulation after second dose". Therapeutic measures were not taken as a result of ovulation pain.  Additional Information:Patient had no other vaccine in four weeks and no other medications in two weeks.Painful double ovulation after second dose which felt like knives in her ovaries.Patient had no covid prior vaccination and not tested covid post vaccination  No follow-up attempts are possible. no further information is expected.
Age: 42.0
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 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 13:00 (Lot number: EW0170) at the age of 42 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: DIZZINESS (non-serious) with onset 24Apr2021, outcome "recovered" (01May2021), described as "Dizziness". Therapeutic measures were not taken as a result of dizziness.  The additional information: The second dose was received on 14May2021 at 14:00 intramuscular in  left arm Batch/Lot number: EW0168. Dizziness started 5 days after vaccination. The event dizziness lasted for 7 days.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: same day- mild arm pain/Next day- moderate arm pain; severe headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Apr2021 11:15 (Lot number: Ew0150) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: cherries" (unspecified if ongoing), notes: Known allergies: Ceclor, cherries. Concomitant medication(s) included: MINOCYCLINE. Past drug history included: Ceclor, reaction(s): "Known allergies: Ceclor", notes: Known allergies: Ceclor, cherries. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 04Apr2021, outcome "recovered" (06Apr2021), described as "same day- mild arm pain/Next day- moderate arm pain"; HEADACHE (non-serious) with onset 04Apr2021, outcome "recovered" (06Apr2021), described as "severe headache". Therapeutic measures were not taken as a result of pain in extremity, headache.  Addition information: Patient had no other vaccine in four weeks. Patient had no COVID prior vaccination and had not tested COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: chills/shivering; headache; sore arm; feverish without a fever; This is a spontaneous report received from a contactable reporter (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 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/shivering"; HEADACHE (non-serious), outcome "unknown", described as "headache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PYREXIA (non-serious), outcome "unknown", described as "feverish without a fever". Patient asked why did he feel feverish without a fever.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: constant vertigo; feeling of dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 38 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "constant vertigo"; DIZZINESS (non-serious), outcome "unknown", described as "feeling of dizziness".  Additional information: 1-2 days post vaccination, patient experienced reported events from waking up to falling asleep.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.