chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: a booster dose (0.25mL) instead of the full dose (3rd dose); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (a booster dose (0.25mL) instead of the full dose (3rd dose)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunosuppression NOS (Azathioprine). Concomitant products included AZATHIOPRINE for an unknown indication.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 03-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (a booster dose (0.25mL) instead of the full dose (3rd dose)). On 03-Nov-2021, ACCIDENTAL UNDERDOSE (a booster dose (0.25mL) instead of the full dose (3rd dose)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications was provided by the reporter.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a physician, describes the occurrence of administered expired product (administration of expired vaccine) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 047C21A) for COVID-19 immunization. No medical history reported. On Nov 9, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Nov 9, 2021, patient administered expired product (administration of expired vaccine). On Nov 9, 2021, administered expired product (administration of expired vaccine) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Sender's comments: This is a spontaneous case of expired product administered for a 45-year-old, female patient with no medical history. No adverse event reported after administration of the booster dose of the Moderna mRNA-1273. The benefit-risk relationship of the Moderna mRNA-1273 not affected by this report. This case linked to MOD-2021-387050 (patient link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: It was a 30 day use by date expiry. The 30 day use by date was 07Nov2021/ When was the vaccine given? 09Nov2021; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (It was a 30 day use by date expiry. The 30 day use by date was 07Nov2021/ When was the vaccine given? 09Nov2021) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (It was a 30 day use by date expiry. The 30 day use by date was 07Nov2021/ When was the vaccine given? 09Nov2021). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (It was a 30 day use by date expiry. The 30 day use by date was 07Nov2021/ When was the vaccine given? 09Nov2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant drug reported. No Treatment drug reported.   This case was linked to MOD-2021-386947 (Patient Link).; Sender's Comments: This case concerns a 59-year-old, male patient, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after booster dose of mRNA 1273 vaccine.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Testicular pain
Clinical narrative: Peripheral neuropathy; Testicle pain; This spontaneous case was reported by a pharmacist and describes the occurrence of NEUROPATHY PERIPHERAL (Peripheral neuropathy) and TESTICULAR PAIN (Testicle pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Peripheral neuropathy) and TESTICULAR PAIN (Testicle pain). At the time of the report, NEUROPATHY PERIPHERAL (Peripheral neuropathy) and TESTICULAR PAIN (Testicle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter. Treatment details was not provided by the reporter. It was reported that the patient's primary care physician (PCP) was suggesting that he get Pfizer as his second dose.  Company Comment This case concerns a male patient with unknown age, with no reported medical history , who experienced non-serious unexpected events of peripheral neuropathy and testicular pain which occurred on an unknown date with the 1st dose of mRNA-1273 Vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the outcome of the events is unknown. . The benefit -risk relationship of mRNA-1273 vaccine (Moderna Covid 19 Vaccine ) is not affected by this report.; Sender's Comments: This case concerns a male patient with unknown age, with no reported medical history , who experienced non-serious unexpected events of peripheral neuropathy and testicular pain which occurred on an unknown date with the 1st dose of mRNA-1273 Vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the outcome of the events is unknown. . The benefit -risk relationship of mRNA-1273 vaccine (Moderna Covid 19 Vaccine ) is not affected by this report.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Illness, Oral herpes, Pain
Clinical narrative: Felt generally ill as if I had gotten the flu; Broke out with fever blisters on lips; Ran slight fever on first night; Body aches more than normal; Headaches; This is a spontaneous report from a contactable consumer (patient himself). A 42-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: 1000784118, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 07Apr2021 at 12:00 (Age at vaccination 42-years-old) as dose 2, single for covid-19 immunization at hospital. Medical history included Hbp, kidney cyst from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE), clonidine (CLONIDINE) taken for hypertension, start and stop date were not reported; meloxicam (MOBIC), paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for hypertension, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: 1000784118, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 07Mar2021 at 12:00 (Age at vaccination 42-years-old) as dose 1, single for covid-19 immunization. The patient experienced after first shot I felt completely fine had no adverse reaction. Felt generally ill as if I had gotten the flu. Broke out with fever blisters on lips. Ran slight fever on first night. Body aches more than normal and headaches on 08Apr2021 at 07:00. Began to feel better by day 3 then felt completely fine by day 5. The patient underwent lab tests and procedures which included body temperature: unknown results on 08Apr2021. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient had receive Suboxone, lisinopril Clonidine(hbp), mobic, tylenol other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received treatment for the events. The clinical outcome of the events was recovered on an unspecified date Apr2021.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Felt generally ill as if I had gotten the flu; Broke out with fever blisters on lips; Ran slight fever on first night; Body aches more than normal; Headaches; This is a spontaneous report from a contactable consumer (patient himself). A 42-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: 1000784118, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 07Apr2021 at 12:00 (Age at vaccination 42-years-old) as dose 2, single for covid-19 immunization at hospital. Medical history included Hbp, kidney cyst from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE), clonidine (CLONIDINE) taken for hypertension, start and stop date were not reported; meloxicam (MOBIC), paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for hypertension, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: 1000784118, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 07Mar2021 at 12:00 (Age at vaccination 42-years-old) as dose 1, single for covid-19 immunization. The patient experienced after first shot I felt completely fine had no adverse reaction. Felt generally ill as if I had gotten the flu. Broke out with fever blisters on lips. Ran slight fever on first night. Body aches more than normal and headaches on 08Apr2021 at 07:00. Began to feel better by day 3 then felt completely fine by day 5. The patient underwent lab tests and procedures which included body temperature: unknown results on 08Apr2021. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient had receive Suboxone, lisinopril Clonidine(hbp), mobic, tylenol other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received treatment for the events. The clinical outcome of the events was recovered on an unspecified date Apr2021.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Hypoaesthesia, Neck pain
Clinical narrative: Has been having like pain in shoulder, numbness; Has been having like pain in shoulder, numbness; The pain started in the shoulder, neck and went down the back.; The pain started in the shoulder, neck and went down the back.; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (Patient).  A 67-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN0164), via an unspecified route of administration, administered in Arm Right (Right shoulder) on 07May2021 (age at the time of vaccination was 67 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. On an unspecified date in 2021, It was reported that the patient has been having like pain in the shoulder, numbness. Seemed like it was not going away. The pain started in the shoulder, neck and went down the back. The pain came and went like nerves. The patient stated that this began just before June. It was still persisting. No investigation Assessment was reported. The caller stated he already saw his doctor. The caller stated he probably needs a new doctor. The outcome of all the events was not recovered.  Follow-Up (10Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Stomatitis
Clinical narrative: full body measle type rash; full body measle type rash which has now changed to new fluid filled sores that expand to almost half inch then bursts.; smaller chicken pox type sores. This continues as of today. Yesterday a large one appeared under my tongue toward the back of my mouth.; This is a spontaneous report from a contactable consumer (patient) and other health professional. A 73-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: ER8730; Expiration Date: Unknown) via an unspecified route of administration, administered in Arm Left on 04Apr2021 at 12:00 am (at the age of 73-years) as dose 2, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior COVID vaccine. Post vaccination, the patient was not diagnosed with COVID-19. No known allergies were reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EP7534; Expiration Date: Unknown) via an unspecified route of administration, administered in Arm Left on 15Mar2021 12:00 am (at the age of 73-years) as dose 1, single for COVID-19 immunization and experienced measle type rash at neck area. The patient experienced full body measle type rash, full body measle type rash which has now changed to new fluid filled sores that expand to almost half inch then burst and smaller chicken pox type sores this continues as of today, yesterday a large one appeared under patient's tongue toward the back of her mouth on 17May2021. Second event following 2nd vaccine: On 17May2021 12:00 am, 14 days following vaccine full body measle type rash which had now changed to new fluid filled sores that expanded to almost half inch then bursts. Also, smaller chicken pox type sores. This continued as of that day. Yesterday a large one appeared under her tongue toward the back of her mouth. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The events were treated with the steroids. The clinical outcome of all the events was not recovered at the time of this report.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Lethargy, Myalgia, Pyrexia
Clinical narrative: lethargy; Flu like symptoms the night of my second dose; muscle aches; chills; low grade fever the next day; This is a spontaneous report from a contactable Consumer or other non-HCP (Patient reported for self). A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0186), via an unspecified route of administration, in left arm on 06Jul2021, as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history included anxiety, temporary schizophrenic symptoms and Allergies: Penicillin and the scent of cinnamon if large amounts. The concomitant medication of the patient was none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown), via an unspecified route of administration, on an unspecified date, as a dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient was not tested for COVID post vaccination. On 06Jul2021, the patient experienced flu like symptoms, muscle aches, chills and low-grade fever. On 07Jul2021 (on the next day), the patient experienced lethargy. The patient received no treatment for the reported events. The outcome for all the reported events was resolved on an unspecified date in Jul2021.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Throat irritation
Clinical narrative: Constant irritation in my throat like working out on a very smoggy day.  Makes me cough all the time.; Makes me cough all the time.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: TN6206 and expiry date was not reported), via an unspecified route of administration in left arm, on 06Mar2021 at 06:30 PM (age at vaccination: 51 years), as single dose for COVID-19 immunization. The patient's medical history includes allergies: penicillin. The patient concomitant medications propranolol started on an unspecified date for an unspecified indication, pantaprozole started on an unspecified date for an unspecified indication, gabapentin started on an unspecified date for an unspecified indication. It was reported that the patient did not had COVID prior vaccination and the patient was not COVID tested post vaccination. Reportedly the patient did not have other vaccine in four weeks. On 19Jul2021 the patient experience constant irritation in his throat like working out on a very smoggy day. Makes him cough all the time. It was reported that the patient received the treatment for the adverse event. The clinical outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Headache, Mydriasis, Ocular hyperaemia
Clinical narrative: I started with a slight headache the day after; The second day I woke up and my eyes hurt, I looked in the mirror and they were bright red and painful. It called the doctor and they said it was allergies; The second day I woke up and my eyes hurt, I looked in the mirror and they were bright red and painful. It called the doctor and they said it was allergies; this has caused it to dilate for a day and then return to normal as well; My eyeballs themselves also seemed swollen.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 38-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number: EW0158) via an unspecified route of administration, administered in right arm on 25Jun2021 16:45 (at the age of 38 years) as dose 1, single dose for covid-19 immunization. No other vaccine administered in four weeks. No covid prior vaccination. The patient's medical history included hypoglycemia and uveitis from an unknown date and unknown if ongoing, known allergies included walnuts allergies from an unknown date and unknown if ongoing. It was reported that in one eye patient have a problem with from birth with dilation. The patient's concomitant medications included in two weeks included (plexus supplements) cisapride (PLEXUS [CISAPRIDE]) taken for an unspecified indication, start and stop date were not reported. On 27Jun2021 06:00 AM, the patient started with a slight headache the day after. the second day she woke up and her eyes hurt, she looked in the mirror and they were bright red and painful. It called the doctor and they said it was allergies, this has caused it to dilate for a day and then return to normal as well, her eyeballs themselves also seemed swollen. It was reported that doctor said it was allergies and gave me drops. It lasted about three days with treatment, but still hurt a little. One eye patient has a problem with from birth with dilation, this has caused it to dilate for a day and then return to normal as well. Patient not tested for covid post vaccination. Therapeutic measures were taken as a result of all the events. Treatment included eye drops. The outcome of the events was recovered on unspecified date in 2021.  Follow-Up (06Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Ocular hyperaemia
Clinical narrative: My eye started to swell and turn red/ both eyes were swollen, painful, and red; My eye started to swell and turn red/ both eyes were swollen, painful, and red; My eye started to swell and turn red/ both eyes were swollen, painful, and red; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 38-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0158, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 16Jul2021 at 15:00 pm (age at vaccination was 38 years) as dose 2, single for COVID-19 immunization. The patient's medical history included hypoglycemia and uveitis. The patient had known allergy to walnuts. Concomitant medication or other medication the patient received in two weeks included Plexus supplements. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0158, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 25Jun2021 at 16:45 pm (age at vaccination was 38 years) as dose 1, single for COVID-19 immunization and the patient's eyes were swollen, painful and red after the first dose of vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 17Jul2021 at 21:15 pm, the day after her shot towards bedtime, the patient's eye started to swell and turn red. When she woke up in the morning the second day, both eyes were swollen, painful and red. Since that happened with the first dose, she did not call her doctor. The patient was using the same eye drops as prescribed before for the events. The outcome of the events was resolving.   Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Intermenstrual bleeding, Menstruation irregular
Clinical narrative: my periods became irregular and I am experience breakthrough irregular bleeding throughout my cycle as well as very painful and heavy periods.; breakthrough irregular bleeding throughout my cycle as well as very painful and heavy periods.; As well as very painful and heavy periods; heavy periods.; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 34-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew 0172, Expiration date: not reported) via an unspecified route of administration, administered in Arm Left on 22Apr2021 at 14.00 (at the age of 34-years-old) as dose 2, single for covid-19 immunization at Pharmacy or Drug Store. Patient was not pregnant at time of Vaccination. The patient's medical history and concomitant medications were not reported. The patient previously took Biaxin and experienced drug allergy. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER 8730, Expiration date: not reported) via an unspecified route of administration in left arm, on 01Apr2021 at 14.00 (at the age of 34-years-old) as dose 1, single for covid-19 immunization. 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 COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive within 2 weeks of vaccination. The patient reported that, on 01May2021 since i have had the vaccine my periods became irregular, and I am experience breakthrough irregular bleeding throughout my cycle as well as very painful and heavy periods. No Hospitalization was required. Event resulted in the Doctor or other healthcare professional office/clinic visit. Device date was reported as 19Jul2021. The outcome of all the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Vaccination site erythema, Vaccination site swelling
Clinical narrative: left arm is swollen and left arm is all red was reported as worsened.; left arm is swollen; left arm is all red; This is a spontaneous report from a contactable consumer (patient).   A 85-years-old female patient received second dose of  bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0191) via intramuscular route, administered in Arm Left on 15Jul2021 10:00 (85-years-old at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. Patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN0178), via intramuscular route, administered in Arm Left on 24Jun2021 (85-years-old at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunization. There were no concomitant medications. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). On 16Jul2021 17:00, the patient experienced left arm is swollen and left arm is all red, left arm is swollen and left arm is all red was reported as worsened. This began late on Friday, 16Jul2021. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pain in extremity, Pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Painfully itchy and pain down the arm and into arm pit.; Swelling, large red spot surrounding injection site; Swelling, large red spot surrounding injection site; Painfully itchy and pain down the arm and into arm pit.; Painfully itchy and pain down the arm and into arm pit; This is a spontaneous report from a contactable other hcp (patient). A 30-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number Fa7485), dose 2 via an unspecified route of administration, administered in Arm Left on 16Jul2021 16:30 (at the age of 30-year-old) as DOSE 2, SINGLE for covid-19 immunization. No other vaccine in four weeks. Medical history included fibromyalgia from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, seasonal allergy from an unknown date and unknown if ongoing Wellbutrin, morphine, seasonal, mold, dust, grass and bleach, mycotic allergy from an unknown date and unknown if ongoing Wellbutrin, morphine, seasonal, mold, dust, grass and bleach, dust allergy from an unknown date and unknown if ongoing Wellbutrin, morphine, seasonal, mold, dust, grass and bleach, seasonal allergy from an unknown date and unknown if ongoing, Wellbutrin, morphine, seasonal, mold, dust, grass and bleach, allergy to chemicals from an unknown date and unknown if ongoing, Wellbutrin, morphine, seasonal, mold, dust, grass and bleach. Concomitant medication(s) included colecalciferol (VIT D3) taken for an unspecified indication, start and stop date were not reported; ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]) taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 for covid-19 immunisation, wellbutrin and experienced drug hypersensitivity, morphine and experienced drug hypersensitivity. On 17Jul2021 20:00 the patient experienced painfully itchy and pain down the arm and into arm pit, swelling, large red spot surrounding injection site, painfully itchy and pain down the arm and into arm pit. No covid prior vaccination, and no covid tested post vaccination. The outcome of events was unknown.  Follow-Up (01Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood glucose, Chest pain, Diarrhoea, Dyspnoea
Clinical narrative: Diarrhea; Some pain in her chest and some breathing problems.; Some pain in her chest and some breathing problems.; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 48-year-old female received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198), via an unspecified route of administration, administered on 13Jul2021 (at the age of 48 years old) as a single dose for COVID-19 immunisation. Medical history included heart condition. The patient reported that she used to drink Aspirin of 81 mg just, as a preventive for any heart condition but it's been around 2 months, that she has stopped taking it. Concomitant medications were not reported. On an unspecified date the patient experienced Diarrhea and Some pain in her chest and some breathing problems. The patient stated that the reason that she was calling was, she had, her first shot of Pfizer BioNTech Covid-19 vaccine on 13Jul2021 and over the last couple of days, she has been having diarrhea and some pain in her chest and some breathing problem. When asked if she wants to report it, consumer stated, yes. The patient stated that she got the lab tests done before she got the first shot. The patient stated that before she gets the first shot, they made her a physique exam on 29Jun2021 and they made all the blood test cholesterol, blood glucose, they made a complete blood count. The patient reported that for diarrhea, it wasn't necessary because it was not that much, that she have diarrhea. For the respiration, for the breathing problem, she hasn't drink anything, that's why she was calling to know, what would be your recommendation, if she have to drink anything like Aspirin or what would you recommend before going to the hospital? Action(s) taken with drug was unknown. On 29Jun2021, the patient underwent lab test that included the blood test cholesterol, blood glucose and complete blood count, blood test with unknown results. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Investigation
Clinical narrative: Diarrhea; Some pain in her chest and some breathing problems.; Some pain in her chest and some breathing problems.; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 48-year-old female received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198), via an unspecified route of administration, administered on 13Jul2021 (at the age of 48 years old) as a single dose for COVID-19 immunisation. Medical history included heart condition. The patient reported that she used to drink Aspirin of 81 mg just, as a preventive for any heart condition but it's been around 2 months, that she has stopped taking it. Concomitant medications were not reported. On an unspecified date the patient experienced Diarrhea and Some pain in her chest and some breathing problems. The patient stated that the reason that she was calling was, she had, her first shot of Pfizer BioNTech Covid-19 vaccine on 13Jul2021 and over the last couple of days, she has been having diarrhea and some pain in her chest and some breathing problem. When asked if she wants to report it, consumer stated, yes. The patient stated that she got the lab tests done before she got the first shot. The patient stated that before she gets the first shot, they made her a physique exam on 29Jun2021 and they made all the blood test cholesterol, blood glucose, they made a complete blood count. The patient reported that for diarrhea, it wasn't necessary because it was not that much, that she have diarrhea. For the respiration, for the breathing problem, she hasn't drink anything, that's why she was calling to know, what would be your recommendation, if she have to drink anything like Aspirin or what would you recommend before going to the hospital? Action(s) taken with drug was unknown. On 29Jun2021, the patient underwent lab test that included the blood test cholesterol, blood glucose and complete blood count, blood test with unknown results. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Nasal congestion, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Cough; Sore throat; Diarrhea; Congestion; Runny nose; This is a spontaneous report from a contactable Other Health Professional (nurse, patients wife reported).  A 39-year-old male patient took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number: EL3248 and Expiry date: Unknown date of Apr2021) via Intramuscular in upper right arm on 11Jan2021(Age at vaccination: 39) as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history included ongoing anemia, ongoing fibrosis since May2021, family history included mother with Hypothyroidism and Asthma, grand mother with DMII, passed from heart surgery, passed from heart surgery, cardiac and Aunt having hypertension and concomitant medications included Womens Prenatal oral Vitamin since 2010 and still ongoing, Iron 65 mg oral still ongoing for historical asthma and vitamin C 1000 to helps in iron absorption orally and till ongoing. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number: EJ1685 and Expiry date: Unknown date of Mar2021) via Intramuscular in right upper arm on 18Dec2021(Age at vaccination: 39) as DOSE 1, 0.3 ML SINGLE for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and had not experienced adverse event. On unknown date of July 2021 patient experienced Cough, Sore throat, Diarrhea, Congestion, Runny nose. On 10Jul2021, 11Jul2021, and 14Jul2021 the patient underwent COVID-19 virus test for the results were negative. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Cough; Sore throat; Diarrhea; Congestion; Runny nose; This is a spontaneous report from a contactable Other Health Professional (nurse, patients wife reported).  A 39-year-old male patient took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number: EL3248 and Expiry date: Unknown date of Apr2021) via Intramuscular in upper right arm on 11Jan2021(Age at vaccination: 39) as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history included ongoing anemia, ongoing fibrosis since May2021, family history included mother with Hypothyroidism and Asthma, grand mother with DMII, passed from heart surgery, passed from heart surgery, cardiac and Aunt having hypertension and concomitant medications included Womens Prenatal oral Vitamin since 2010 and still ongoing, Iron 65 mg oral still ongoing for historical asthma and vitamin C 1000 to helps in iron absorption orally and till ongoing. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number: EJ1685 and Expiry date: Unknown date of Mar2021) via Intramuscular in right upper arm on 18Dec2021(Age at vaccination: 39) as DOSE 1, 0.3 ML SINGLE for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and had not experienced adverse event. On unknown date of July 2021 patient experienced Cough, Sore throat, Diarrhea, Congestion, Runny nose. On 10Jul2021, 11Jul2021, and 14Jul2021 the patient underwent COVID-19 virus test for the results were negative. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Oligomenorrhoea
Clinical narrative: Spotting between menstrual cycles; extended menstrual cycles; extreme heavy bleeding during menstrual cycles; This is a spontaneous report from a contactable consumer (patient).  A 36-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 28Apr2021 (Batch/Lot Number: EW0170) (age at vaccination 36-year-old) as dose 2, single for covid-19 immunisation at Pharmacy or Drug Store. The patient had no known allergies. Medical history was reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications included lamotrigine within 2 weeks of vaccination. The patient received historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 07Apr2021 (Batch/Lot Number: EW0151) (age at vaccination 36-year-old) as dose 1, single for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced spotting between menstrual cycles, extended menstrual cycles and extreme heavy bleeding during menstrual cycles on 09May2021. The patient did not received any treatment for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heavy menstrual bleeding, Inappropriate schedule of product administration, Menstrual disorder
Clinical narrative: I am currently having severe menstrual flow; I was on the aspirin before without such a heavy flow. My current flow is almost 10x what it was.; Also I am now having frequent head aches; dose number: 2 administration date: 06Apr2021/dose number: 1 administration date: 06Apr2021; This is a spontaneous report from a contactable consumer (patient). A 44-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number er8731), dose 2 via an unspecified route of administration, administered in Arm Right on 06Apr2021 as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 (Batch/Lot Number: ep7533) as DOSE 1, SINGLE for covid-19 immunization. No other vaccine in four weeks, and other medications in two weeks: asprin 81mg. Medical history included sinus disorder from an unknown date and unknown if ongoing. Concomitant medication(s) included acetylsalicylic acid (ASPRIN) taken for an unspecified indication, start and stop date were not reported. The patient previously took septra and experienced hypersensitivity. On 22May2021 the patient experienced i am currently having severe menstrual flow, i was on the aspirin before without such a heavy flow. my current flow is almost 10x what it was, also i am now having frequent head aches. No COVID prior vaccination, and no COVID tested post vaccination. On 06Apr2021 dose number: 2 administration date: 06apr2021/dose number: 1 administration date: 06apr2021. 06Apr2021 the outcome of event on 06Apr2021 was recovered, and other events was not recovered  Follow-up (24Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Dry skin, Fatigue, Feeling hot
Clinical narrative: rash; It started with fatigue; chills; I had extreme body heat; dry skin; burning sensation in my arms and feet; This is a spontaneous report from a contactable consumer (Patient) or other non-HCP.  A 39-year-old male received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EW0150) via an intramuscular route of administration, administered in Arm Left on 01Apr2021 (at 16:30) (age at the time of vaccination was 39-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Relevant medical history and concurrent conditions included No Gallbladder, have weak digestion because of it from an unspecified date. Concomitant medications received within 2 weeks of vaccination included Vitamin D3 supplement. The patient had no relevant past drug history. The patient had no known allergies. The patient had no prior vaccinations within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 01May2021 (at 01:00), the patient experienced It started with fatigue, chills, I had extreme body heat, dry skin, burning sensation in my arms and feet. On 02May2021, the patient experienced rash. The patient received Steroids and antihistamines as treatment medications. The patient underwent lab tests and medical procedures on 10May2021 which included Full blood count which showed result Normal and Metabolic function test which showed result Normal. The clinical outcome of It started with fatigue, chills, I had extreme body heat, dry skin, burning sensation in my arms and feet was Not recovered, while the clinical outcome of rash was unknown.  Follow-Up (20Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Metabolic function test, Rash
Clinical narrative: rash; It started with fatigue; chills; I had extreme body heat; dry skin; burning sensation in my arms and feet; This is a spontaneous report from a contactable consumer (Patient) or other non-HCP.  A 39-year-old male received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EW0150) via an intramuscular route of administration, administered in Arm Left on 01Apr2021 (at 16:30) (age at the time of vaccination was 39-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Relevant medical history and concurrent conditions included No Gallbladder, have weak digestion because of it from an unspecified date. Concomitant medications received within 2 weeks of vaccination included Vitamin D3 supplement. The patient had no relevant past drug history. The patient had no known allergies. The patient had no prior vaccinations within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 01May2021 (at 01:00), the patient experienced It started with fatigue, chills, I had extreme body heat, dry skin, burning sensation in my arms and feet. On 02May2021, the patient experienced rash. The patient received Steroids and antihistamines as treatment medications. The patient underwent lab tests and medical procedures on 10May2021 which included Full blood count which showed result Normal and Metabolic function test which showed result Normal. The clinical outcome of It started with fatigue, chills, I had extreme body heat, dry skin, burning sensation in my arms and feet was Not recovered, while the clinical outcome of rash was unknown.  Follow-Up (20Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Dyspnoea, Fatigue
Clinical narrative: aguesia; anosmia; fatigue; body aches; cough; shortness of breath; This is a spontaneous report from a contactable other-health care professional.  A 25-year-old male patient BNT162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number EK5730) in left arm, intramuscularly as dose 2, single on 23Mar2021 for covid-19 immunization. The patient age at vaccination was 24 years old. The patient medical history and concomitant medications were not reported. Vaccination history included BNT162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number EJ1685) in left arm, intramuscularly as dose 1, single on 01Mar2021 for covid-19 immunization. On 14Jul2021, the patient experienced aguesia, anosmia, fatigue, body aches, cough and shortness of breath. The outcome of events was Not recovered.  Follow-up attempts are completed. No further information is expected
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: aguesia; anosmia; fatigue; body aches; cough; shortness of breath; This is a spontaneous report from a contactable other-health care professional.  A 25-year-old male patient BNT162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number EK5730) in left arm, intramuscularly as dose 2, single on 23Mar2021 for covid-19 immunization. The patient age at vaccination was 24 years old. The patient medical history and concomitant medications were not reported. Vaccination history included BNT162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number EJ1685) in left arm, intramuscularly as dose 1, single on 01Mar2021 for covid-19 immunization. On 14Jul2021, the patient experienced aguesia, anosmia, fatigue, body aches, cough and shortness of breath. The outcome of events was Not recovered.  Follow-up attempts are completed. No further information is expected