chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Tightness in chest; This is a spontaneous report from a contactable healthcare professional (patient) received via database. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on 08Mar2021 at 10:15 AM (Lot Number: EN6201) (at the age of 25 years old) as dose number unknown, single for COVID-19 immunisation. Medical history included birth control use. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient has no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC) taken as birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced tightness in chest on 08Mar2021. The patient has not taken any treatment for the event. The patient recovered from tightness in chest on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Nasopharyngitis
Clinical narrative: Cold like symptoms; bloody nose at least once a day; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 04Mar2021 at 13:15 (at the age of 64-years-old) as dose 1, single for COVID-19 immunisation. Medical history included high blood pressure, anxiety and stage 3 kidney disease. Concomitant medications included lisinopril, sertraline and lorazepam, all taken for an unspecified indication, start and stop dates were not reported. The patient experienced cold like symptoms and bloody nose at least once a day on 05Mar2021 at 04:00. There was no treatment received for the events. The outcome of the events was not recovered.   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, Pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: raised circular red area surrounding the injection site on the left shoulder; raised circular red area surrounding the injection site on the left shoulder; sustained itching and soreness; sustained itching and soreness; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the left arm also reported as left shoulder, on an unspecified date (Batch/lot number not reported), as dose 1, single, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, approximately 1 week following the vaccination, the patient experienced raised circular red area surrounding the injection site on the left shoulder. On an unspecified date, the patient experienced sustained itching and soreness. The events took place after vaccination. The outcome of the event raised circular red area surrounding the injection site on the left shoulder was unknown, and sustained itching and soreness was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nasopharyngitis, Rhinorrhoea, Sneezing
Clinical narrative: sneezing; headache; extreme runny nose; head cold symptoms; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 08Mar2021 17:15 (Batch/Lot number was not reported)(at age 62-years-old) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. There were no other vaccine within 4 weeks. The patient previously took aspirin and experienced drug hypersensitivity.  About 15-16 hours after the vaccination on 09Mar2021 09:00, patient began repeatedly sneezing and having head cold symptoms (extreme runny nose, headache). It felt like a peak day during allergy season. There were on treatment for the events. Outcome of the events was recovering. Patient was not diagnosed with covid prior to vaccination and had not been tested post-vaccination  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rashes; skin itch; This is a spontaneous report from a Pfizer Sponsored Program.  A contactable consumer reported that a female patient (reporter's mother) of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter was calling on behalf of her mother's experience after taking the first dose of the COVID vaccine. The patient was scheduled for her second dose on 10Mar2021 but she has rashes and skin itch. The patient's doctor advised the patient not to take the second dose of the vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: knee pain; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included knee injury in 2021 (prior to vaccination). The patient's concomitant medications were not reported. The patient had a knee injury last week (in 2021, prior to vaccination). On 09Mar2021, the patient received the 1st shot and experienced knee pain. The patient would like to know if she can take Tylenol for knee pain. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Pain, Pain in extremity, Rash
Clinical narrative: severe pain; rashes; pain in back; pain in the back and shoulder down to arm; pain in the back and shoulder down to arm; This is a spontaneous report from a contactable consumer from the Pfizer-sponsored program. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the COVID-19 Vaccine on 05Mar2021 and after two hours, the patient had pain in the back and shoulder down to arm. Then in the morning of 08Mar2021, rashes showed up from the top of the shoulder down to the elbow. She also experienced severe pain on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Constipation, Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: fatigue a lot; constipation; little pain in my joints - knees and heels; arm pain; a little fever; feel a little bad; This is a spontaneous report from a contactable healthcare professional. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 at the age of 52-year-old via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She got the Pfizer vaccine and reports having experienced arm pain, "a little fever" and "feel a little bad" for one day after the vaccine. She still experiences "fatigue a lot" as well as constipation and "little pain in my joints-knees and heels". The outcome of the events arm pain, "a little fever" and "feel a little bad" was unknown, and not recovered for the rest of the events.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fatigue a lot; constipation; little pain in my joints - knees and heels; arm pain; a little fever; feel a little bad; This is a spontaneous report from a contactable healthcare professional. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 at the age of 52-year-old via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She got the Pfizer vaccine and reports having experienced arm pain, "a little fever" and "feel a little bad" for one day after the vaccine. She still experiences "fatigue a lot" as well as constipation and "little pain in my joints-knees and heels". The outcome of the events arm pain, "a little fever" and "feel a little bad" was unknown, and not recovered for the rest of the events.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Burning, itching rash all over body that began the night of the  vaccine; Burning, itching rash all over body that began the night of the  vaccine; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 45-year-old, via an unspecified route of administration, administered in left arm on 21Feb2021 08:30 (Lot Number: EL9269) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced burning, itching rash all over body that began the night of the vaccine on 21Feb2021 20:00 and progressively spread all over 3 days later. The patient did not receive any treatment for the events. The outcome of the events was recovered on 28Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: muscle soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 27Jan2021 at 14:00 (at the age of 34-years-old) (Lot Number: EL3247) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included ibuprofen (strength: 600 mg) and vitamin D3. The patient did not have COVID prior to vaccination and had not been tested for COVID post-vaccination. On 28Jan2021, the patient experienced muscle soreness at injection site. No treatment was received for the event. The outcome of the event recovered on 31Jan2021.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Decreased immune responsiveness, Pruritus
Clinical narrative: I'm not million percent sure if the little bit local itching wasn't; my immune system is already so low that it doesn't over react easily; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included psoriatic arthropathy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date the patient experienced I'm not million percent sure if the little bit local itching wasn't, my immune system is already so low that it doesn't overreact easily, I don't know if it was super easy because my immune system is already so low that it doesn't overreact easily but. following information was not provided during the call: Patient gender The outcome of the events pruritus decreased immune responsiveness was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: event "off label use" deleted. This follow-up report is being submitted to allow appropriate reporting to health authorities.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Fatigue, Hypersensitivity, Pruritus
Clinical narrative: I had like allergic reaction like itching; I had like allergic reaction like itching; I feel hydrated too and I am tired; I feel dehydrated too and I am tired'; This is a spontaneous report from a contactable consumer or other non hcp. A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: EP7534), dose 2 via an unspecified route of administration on 16Mar2021 (Vaccination at the age of 60 years) as DOSE 2, SINGLE for covid-19 immunisation. NDC number and UPC number of COVID Vaccine: Unknown. The patient's medical history and concomitant medications were not reported. Patient previously took bnt162b2 (LOT#: Consumer stated, "EN62, looks like 31 or 51.") on 23Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient had like allergic reaction like itching (hypersensitivity) (pruritus), felt dehydrated too and was tired (fatigue) (dehydration) on an unspecified date. Outcome of the event like allergic reaction like itching (hypersensitivity) was not recovered and other events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. A female patient, of an unspecified age, received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection; batch/lot# and expiration date not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient previously vaccinated with flu shot for influenza immunization on an unspecified date. With the COVID-19 vaccine, patient experienced muscle spasms and soreness in her arm on an unspecified date. Reportedly, it felt like when she gets a flu shot. The outcome of the events: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-2021206222 Same reporter and product, similar event; different patient.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Lymph node pain, Lymphadenopathy
Clinical narrative: Golf ball sized, painful lymph node in bend of left arm.  Right at elbow; Golf ball sized, painful lymph node in bend of left arm.  Right at elbow; Mild diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: EW0162), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 13:00 (Vaccination at the age of 53 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included drug hypersensitivity (Known allergies: Sulfa) from an unknown date. There were no concomitant medications. The patient previously took acetaminophen and experienced drug hypersensitivity, bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: ER7833), dose 1 via an unspecified route of administration, administered in Arm Left on 24Mar2021 14:30 (Vaccination at the age of 53 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced golf ball sized, painful lymph node in bend of left arm. Right at elbow and mild diarrhea on 14Apr2021 08:30. Patient didn't took other vaccine in four weeks, didn't had covid prior vaccination and not tested covid post vaccination. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Headache; exhaustion; sinus pressure; fever; chills; sweats; dizzy; nausea; stomach aches; diarrhea; brain fog; sleep issues; Due to nausea & brain fog unable to work as bookkeeper; This is a spontaneous report from a contactable consumer or other non hcp.   A 57-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 14Mar2021 (Batch/Lot Number: EP7534) as DOSE 1, SINGLE for covid-19 immunisation (57-years at the age of vaccination).Medical history included asthma from an unknown date and unknown if ongoing , hypersensitivity from an unknown date and unknown if ongoing , allergy to animal from an unknown date and unknown if ongoing. Concomitant medication included clarithromycin (CLARITIN [CLARITHROMYCIN]) taken for an unspecified indication, start and stop date were not reported.  The patient experienced headache, exhaustion, sinus pressure, fever, chills, sweats, dizzy, nausea, stomach aches, diarrhea , brain fog, sleep issues, due to nausea & brain fog unable to work as bookkeeper on 14Mar2021. Therapeutic measures were taken as a result of all events. The outcome of the events Headache, exhaustion, nausea, stomach aches, brain fog, sleep issues and Due to nausea & brain fog unable to work as bookkeeper was not resolved and other events was resolved on 2021.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hyperhidrosis, Loss of personal independence in daily activities, Nausea
Clinical narrative: Headache; exhaustion; sinus pressure; fever; chills; sweats; dizzy; nausea; stomach aches; diarrhea; brain fog; sleep issues; Due to nausea & brain fog unable to work as bookkeeper; This is a spontaneous report from a contactable consumer or other non hcp.   A 57-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 14Mar2021 (Batch/Lot Number: EP7534) as DOSE 1, SINGLE for covid-19 immunisation (57-years at the age of vaccination).Medical history included asthma from an unknown date and unknown if ongoing , hypersensitivity from an unknown date and unknown if ongoing , allergy to animal from an unknown date and unknown if ongoing. Concomitant medication included clarithromycin (CLARITIN [CLARITHROMYCIN]) taken for an unspecified indication, start and stop date were not reported.  The patient experienced headache, exhaustion, sinus pressure, fever, chills, sweats, dizzy, nausea, stomach aches, diarrhea , brain fog, sleep issues, due to nausea & brain fog unable to work as bookkeeper on 14Mar2021. Therapeutic measures were taken as a result of all events. The outcome of the events Headache, exhaustion, nausea, stomach aches, brain fog, sleep issues and Due to nausea & brain fog unable to work as bookkeeper was not resolved and other events was resolved on 2021.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort, Pyrexia, Sleep disorder
Clinical narrative: Headache; exhaustion; sinus pressure; fever; chills; sweats; dizzy; nausea; stomach aches; diarrhea; brain fog; sleep issues; Due to nausea & brain fog unable to work as bookkeeper; This is a spontaneous report from a contactable consumer or other non hcp.   A 57-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 14Mar2021 (Batch/Lot Number: EP7534) as DOSE 1, SINGLE for covid-19 immunisation (57-years at the age of vaccination).Medical history included asthma from an unknown date and unknown if ongoing , hypersensitivity from an unknown date and unknown if ongoing , allergy to animal from an unknown date and unknown if ongoing. Concomitant medication included clarithromycin (CLARITIN [CLARITHROMYCIN]) taken for an unspecified indication, start and stop date were not reported.  The patient experienced headache, exhaustion, sinus pressure, fever, chills, sweats, dizzy, nausea, stomach aches, diarrhea , brain fog, sleep issues, due to nausea & brain fog unable to work as bookkeeper on 14Mar2021. Therapeutic measures were taken as a result of all events. The outcome of the events Headache, exhaustion, nausea, stomach aches, brain fog, sleep issues and Due to nausea & brain fog unable to work as bookkeeper was not resolved and other events was resolved on 2021.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Laryngospasm, Pain in extremity, Panic reaction
Clinical narrative: Laryngeal spasm; panicked; sore arm; This is a spontaneous report from a contactable Nurse/patient (reported for herself). A 52-years-old non-pregnant female patient started to receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6208) via intramuscularly administered on left arm on 15Mar2021 10:30 AM (age at vaccination: 51 years old) as a dose 1, single for covid-19 immunisation. Medical history included allergy to latex (latex allergy with prolonged exposure such as wearing latex gloves daily). Patient had no covid prior vaccination. Patient has not been tested for covid post vaccination. The concomitant medications included vitamin B NOS (VITAMIN B) drops, ergocalciferol (VITAMIN D) drops and "unknown calcium supplement". On an unknown date in 15Mar2021 3:30 PM, patient had laryngeal spasm which occurred about 5 hours after the vaccination. My airway started to feel like it was closing up and started to have difficulty breathing. It lasted maybe about a minute or less, but left me panicked. I called my husband who is an ENT physician who considered it a laryngeal spasm. Patient also had sore arm on an unknown date in Mar2021 at vaccinated arm. The patient did not receive any treatment for the events. The outcome of the event sore arm was unknown and other events was resolved on 15Mar2021.  No follow up attempts are possible; Information about lot/batch number cannot be requested. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Urinary incontinence, Vaccination site pain
Clinical narrative: Injection site pain; Severe fatigue; Severe Urinary incontinence; Headaches; This is a spontaneous report from a contactable consumer (patient) reported herself. A 51-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EW0151), via an unknown route of administration in left arm on 17Apr2021 (at the age of 51-years-old) as dose 2, single for COVID-19 immunization at public health department. The patient's medical history included diabetes II, high blood pressure, reflux, anxiety, obesity and menopause. Concomitant medication was not reported. The patient received morphine, Wellbutrin as past medication and experienced known allergies. The patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: ER8727), via an unknown route of administration in left arm on 19Mar2021 (at the age of 51-years-old) as historical vaccine as dose 1, single for COVID-19 immunization. No other vaccine in four weeks. On 17Apr2021, the patient experienced injection site pain, severe fatigue, severe urinary incontinence and headaches. Continued on day 3. No COVID prior vaccination. No COVID tested post vaccination. No treatment for event. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Head injury
Clinical narrative: cut her head; Patients second dose greater than 3 weeks due to fall; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on 27Mar2021 as DOSE 1, SINGLE for covid-19 immunization. Medical history included ongoing gastroesophageal reflux disease Verbatim: acid relux , ongoing hypertension Verbatim: high blood pressure , ongoing anxiety Verbatim: Anxiety. The patient received tetanus, a week after she fell, not given at hospital went to doctor 4-5 days later she gave her a tetanus shot vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications of vaccination. The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. Concomitant medication(s) included omeprazole (OMEPRAZOLE) taken for gastroesophageal reflux disease, start and stop date were not reported.On 17Apr2021 the patient experienced patient fell trying to get to second vaccine, cut her head, patients second dose greater than 3 weeks due. The outcome of event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: To delete the event Missed dose.
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: had smells of burning and gasoline; This is a spontaneous report from a contactable consumer (patient's sister) received via agency. This consumer reported similar events for two patients. This is the 2nd of two reports. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had smells of burning and gasoline. The outcome of the event was unknown.  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-2021187152 same reporter and drug, similar event, different patient
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Diarrhoea, Inflammation, Limb discomfort, Stool analysis
Clinical narrative: Instant and severe diarrhea; White blood cells indicated inflammation.; Heavy legs at night; This is a spontaneous report from a contactable consumer (patient). A 51-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number, Expiry date: not reported) via an unspecified route of administration, administered in arm left on 14Apr2021 at 16:00 (age at vaccination 51-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number and Expiry date: not reported) via an unspecified route of administration, administered in arm left on 22Apr2021 at 16:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included birth control from an unknown date and unknown if ongoing (patient received birth control pills other medications in two weeks). The patient had no known allergies. The patient concomitant medications were not reported. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 15Apr2021 16:00, the patient had experienced instant and severe diarrhoea started about 24 hours after second injection. It had not stopped for over six weeks. I went to the doctor at four weeks and did bloodwork and provided stool sample. White blood cells indicated inflammation. I also had heavy legs at night which was also new and very scary. The patient did not receive treatment for the adverse event. The adverse event resulted in doctor or other healthcare professional office/clinic visit. On an unspecified date 2021, the patient underwent lab tests and procedures which included blood test: unknown result, stool analysis: unknown result. The outcome of events was not recovered.  Follow-up activities closed. Batch/lot number not available for [Vaccine BNT162B2].
Sex: U
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Flatulence, Lethargy, Nausea
Clinical narrative: Ongoing Stomach cramps; Nausea; bloating; lethargy; foul smelling gas; This is a spontaneous report from a contactable Consumer. This Consumer reported similar events for herself and 3 patients. This report is for 1st of 3 patient. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose number unknown, single for COVID-19 immunisation at clinic. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination and did not test for COVID post vaccination. On an unspecified date, the patient experienced ongoing stomach cramps, nausea, bloating, lethargy and foul smelling gas. Effecting the ability to work. Three other people the patient know had all been complaining about the same symptoms. The symptoms were not subsiding. The patient did not receive any treatment for the events. Outcome of the events was unknown.  The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow up.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Burning sensation, Discomfort, Facial pain
Clinical narrative: experiencing shooting pains down my arm where I was vaccinated pain radiates into my shoulder and elbow; experiencing shooting pains down my arm where I was vaccinated pain radiates into my shoulder and elbow, Pain in hand; I feel tingles, burning, itching, and numbness; I feel tingles, burning, itching, and numbness; I feel tingles, burning, itching, and numbness; This also radiates into my hands and my face on the left side has also experienced some shooting pain and numbness; This also radiates into my hands and my face on the left side has also experienced some shooting pain and numbness; This also radiates into my hands and my face on the left side has also experienced some shooting pain and numbness; This also radiates into my hands and my face on the left side has also experienced some shooting pain and numbness; anxiety; My menstrual cycle was also been delayed for 14 days; pretty uncomfortable for me; This is a spontaneous report from a contactable Consumer or other non-health care professional (Patient).  A 22-Years-Old Non-pregnant Female received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no/Lot number: not reported) via an unspecified route of administration on an unknown date at the age of 22-years-old as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. No Known allergies were reported. Historical vaccine included patient took bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation:  solution for injection; Batch no/Lot number: not reported) via an unspecified route of administration, administered in left arm on 31Mar2021 03:00 PM (at the age of 22-years-old) as dose 1, single for COVID-19 immunization. Patient did not receive other vaccines within four weeks and No other medications received within two weeks of vaccination. Patient was not diagnosed with covid prior vaccination and not tested post vaccination. On 02Jun2021 at 10:00 AM, 6 weeks post 2nd vaccine patient has been experiencing shooting pains down her arm where she was vaccinated, pain radiates into her shoulder and elbow. She felt tingles, burning, itching, and numbness and also radiates into her hands and her face on the left side has also experienced some shooting pain and numbness. Patient thought some of that could be anxiety-induced but the arm issues are a bit concerning for her. It does come and go but it has been pretty uncomfortable for her. Her menstrual cycle was also been delayed for 14 days. But it did come. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events caused. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Menstruation delayed, Pain in extremity, Paraesthesia, Pruritus
Clinical narrative: experiencing shooting pains down my arm where I was vaccinated pain radiates into my shoulder and elbow; experiencing shooting pains down my arm where I was vaccinated pain radiates into my shoulder and elbow, Pain in hand; I feel tingles, burning, itching, and numbness; I feel tingles, burning, itching, and numbness; I feel tingles, burning, itching, and numbness; This also radiates into my hands and my face on the left side has also experienced some shooting pain and numbness; This also radiates into my hands and my face on the left side has also experienced some shooting pain and numbness; This also radiates into my hands and my face on the left side has also experienced some shooting pain and numbness; This also radiates into my hands and my face on the left side has also experienced some shooting pain and numbness; anxiety; My menstrual cycle was also been delayed for 14 days; pretty uncomfortable for me; This is a spontaneous report from a contactable Consumer or other non-health care professional (Patient).  A 22-Years-Old Non-pregnant Female received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no/Lot number: not reported) via an unspecified route of administration on an unknown date at the age of 22-years-old as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. No Known allergies were reported. Historical vaccine included patient took bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation:  solution for injection; Batch no/Lot number: not reported) via an unspecified route of administration, administered in left arm on 31Mar2021 03:00 PM (at the age of 22-years-old) as dose 1, single for COVID-19 immunization. Patient did not receive other vaccines within four weeks and No other medications received within two weeks of vaccination. Patient was not diagnosed with covid prior vaccination and not tested post vaccination. On 02Jun2021 at 10:00 AM, 6 weeks post 2nd vaccine patient has been experiencing shooting pains down her arm where she was vaccinated, pain radiates into her shoulder and elbow. She felt tingles, burning, itching, and numbness and also radiates into her hands and her face on the left side has also experienced some shooting pain and numbness. Patient thought some of that could be anxiety-induced but the arm issues are a bit concerning for her. It does come and go but it has been pretty uncomfortable for her. Her menstrual cycle was also been delayed for 14 days. But it did come. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events caused. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: experiencing shooting pains down my arm where I was vaccinated pain radiates into my shoulder and elbow; experiencing shooting pains down my arm where I was vaccinated pain radiates into my shoulder and elbow, Pain in hand; I feel tingles, burning, itching, and numbness; I feel tingles, burning, itching, and numbness; I feel tingles, burning, itching, and numbness; This also radiates into my hands and my face on the left side has also experienced some shooting pain and numbness; This also radiates into my hands and my face on the left side has also experienced some shooting pain and numbness; This also radiates into my hands and my face on the left side has also experienced some shooting pain and numbness; This also radiates into my hands and my face on the left side has also experienced some shooting pain and numbness; anxiety; My menstrual cycle was also been delayed for 14 days; pretty uncomfortable for me; This is a spontaneous report from a contactable Consumer or other non-health care professional (Patient).  A 22-Years-Old Non-pregnant Female received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no/Lot number: not reported) via an unspecified route of administration on an unknown date at the age of 22-years-old as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. No Known allergies were reported. Historical vaccine included patient took bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation:  solution for injection; Batch no/Lot number: not reported) via an unspecified route of administration, administered in left arm on 31Mar2021 03:00 PM (at the age of 22-years-old) as dose 1, single for COVID-19 immunization. Patient did not receive other vaccines within four weeks and No other medications received within two weeks of vaccination. Patient was not diagnosed with covid prior vaccination and not tested post vaccination. On 02Jun2021 at 10:00 AM, 6 weeks post 2nd vaccine patient has been experiencing shooting pains down her arm where she was vaccinated, pain radiates into her shoulder and elbow. She felt tingles, burning, itching, and numbness and also radiates into her hands and her face on the left side has also experienced some shooting pain and numbness. Patient thought some of that could be anxiety-induced but the arm issues are a bit concerning for her. It does come and go but it has been pretty uncomfortable for her. Her menstrual cycle was also been delayed for 14 days. But it did come. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events caused. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Pain chest; This is a spontaneous report from a contactable consumer. This 15-year-old female contactable consumer(patient) reported that.  A 15-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 12Jun2021 09:00 as (At the age of 15-years) dose 2, single for covid-19 immunisation. Medical history included back pain from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient was not pregnant at the time of vaccination. No other vaccine in four weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 22May2021 09:00 AM as (At the age of 15-years) dose 1, single for covid-19 immunisation. It was Unknown if patient had covid prior vaccination. No covid tested post vaccination. No Known allergies ware reported. The patient experienced pain chest on 14Jun2021 08:00. Patient did not receive any treatment for events. The outcome of event was not recovered at the time of report.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Headache
Clinical narrative: Chest pain; shortness of breath; headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 61-years-old non-pregnant female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN6708 and Expiration date was unknown) via intramuscular route of administration, administered in left arm on 03Mar2021 at 18:00 hours as dose 1, single for Covid-19 immunization. The patient medical history was not reported. Patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient received unspecified medications as concomitant medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 01May2021 at 00:00 hours, patient experienced chest pain, shortness of breath and headache. Patient did not receive any treatment for the events. The outcome of all the events was unknown.  Information on the lot/ batch number has been requested.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Fluzone taken on 15-sep-2021, estimated date of delivery: 09-Oct-2021, with nno reported advere event; Initial information was received on 15-Sep-2021 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 29 years old female patient who was exposed to vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] on 15-sep-2021, estimated date of delivery: 09-oct-2021 at unknown gestation period (exposure during pregnancy).   Data regarding this pregnancy were received prospectively.  The date of last menstrual period was reported as 2021.  The estimated due date is 09-Oct-2021.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  The patient had no previous pregnancy/ies.   On 15-Sep-2021, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (Suspension for injection, lot 4T7325QA and expiry date: 30-Jun-2022) via intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of vaccine exposure during pregnancy (latency: same day).  At the time of reporting, no adverse event was reported.  Additionally, at time of reporting, the pregnancy is still ongoing and the outcome of the pregnancy was unknown.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: administered PENTACEL to a patient without reconstituting/ only liquid portion was administered with no reported adverse event; Initial information was received on 14-Sep-2021 regarding an unsolicited valid non-serious case from a other healthcare professional  via Media Information (under reference 00768848).  This case involves a 2-month-old female patient who was administered with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without reconstituting/ given only liquid portion (product preparation issue).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) (other dosing details were not reported).  On 09-Sep-2021, the patient received 0.5 ml first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (1x, total, lot UJ542AA, expiry date 10-Jul-20222) via an intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to inappropriate reconstitution technique (same day).  It was reported "caller states that they administered PENTACEL to a patient without reconstituting. Caller clarifies, only liquid portion was administered to patient. Caller asks what they should do for the patient in this situation.   At the time of reporting no adverse event was reported and the outcome was unknown for the reported event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Initial information was received on 14-Sep-2021 regarding an unsolicited valid non-serious case from a other health professional.