chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe bodyaches; Especially back & front thigh to below knee; Especially back & front thigh to below knee; Especially back & front thigh to below knee; Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UUNKOWN) via an unspecified route of administration in the right arm on 07Apr2021 at 15:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, diabetes 2 and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included multiple plus insulin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 07Apr2021 at 16:30, the patient experienced severe body aches especially back & front thigh to below knee, fatigue and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events severe body aches especially back & front thigh to below knee, fatigue and headache were not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: Swollen left hand and fingers; Swollen left hand and fingers; Tingling; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 08Apr2021 at 17:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included cardiomyopathy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 08Apr2021 at 17:45, the patient experienced swollen left hand, fingers and tingling. Less severe on right side. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen left hand, fingers and tingling was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Dysgeusia, Gait disturbance
Clinical narrative: arm got sore; upset stomach; terrible taste on the mouth  - metallic taste; does not have much of an appetite and gait is a little off; does not have much of an appetite and gait is a little off; chills; sweats; headache; feeling sick; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8729), via an unspecified route of administration, administered in Arm Right on 06Apr2021 (at the age of 85-year-old) as single dose for COVID-19 immunization. Medical history included prior Covid virus survivor, that she was hospitalized in Apr2020 and intubated, states she had to have surgery a couple of weeks ago, had vocal cord surgery due to damage from being intubated, prior to vaccine. History of COVID 19 infection and was intubated 07Apr2021 (as reported)- Patient undergone surgery for removal of large cyst in the vocal cord last Mar2021. She had cellulitis in left arm around a year and a half ago so she got the vaccine in her right. Concomitant medication(s) included atorvastatin taken for cholesterol from an unspecified start date and ongoing. The patient experienced chills, sweats, headache, upset stomach, no appetite, terrible taste on the mouth - metallic taste and gait was off since 08Apr2021; arm got sore since 09Apr2021. Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE last 07Apr2021 (as reported) and she experienced feeling sick, chills, sweats, headache, arm got sore, upset stomach, terrible taste on the mouth - metallic taste. The patient stated she had her first dose of the Pfizer Covid vaccine on Tuesday morning 06Apr2021, states she had never been that sick, states she felt like she had every side effect she could possibly have. After the vaccine she was alright during the day and at home, states she then woke up in the early hours Thursday morning, 08Apr2021, states she had a headache, sweats, chills, that her arm did not bother her until this morning (09Apr2021), had upset stomach, the taste in her mouth was unbelievable, felt a little better, was improving, did not have much of an appetite and gait was a little off, but better. Asking if the 2nd dose will give her more side effects and if she could still get the 2nd shot because of the reactions. Caller wanted to know if she should have not gotten the vaccine since she had Covid last year. Outcome of the event sore arm, gait is off was not recovered; feeling sick was unknown; other events was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Malaise, Pain in extremity
Clinical narrative: arm got sore; upset stomach; terrible taste on the mouth  - metallic taste; does not have much of an appetite and gait is a little off; does not have much of an appetite and gait is a little off; chills; sweats; headache; feeling sick; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8729), via an unspecified route of administration, administered in Arm Right on 06Apr2021 (at the age of 85-year-old) as single dose for COVID-19 immunization. Medical history included prior Covid virus survivor, that she was hospitalized in Apr2020 and intubated, states she had to have surgery a couple of weeks ago, had vocal cord surgery due to damage from being intubated, prior to vaccine. History of COVID 19 infection and was intubated 07Apr2021 (as reported)- Patient undergone surgery for removal of large cyst in the vocal cord last Mar2021. She had cellulitis in left arm around a year and a half ago so she got the vaccine in her right. Concomitant medication(s) included atorvastatin taken for cholesterol from an unspecified start date and ongoing. The patient experienced chills, sweats, headache, upset stomach, no appetite, terrible taste on the mouth - metallic taste and gait was off since 08Apr2021; arm got sore since 09Apr2021. Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE last 07Apr2021 (as reported) and she experienced feeling sick, chills, sweats, headache, arm got sore, upset stomach, terrible taste on the mouth - metallic taste. The patient stated she had her first dose of the Pfizer Covid vaccine on Tuesday morning 06Apr2021, states she had never been that sick, states she felt like she had every side effect she could possibly have. After the vaccine she was alright during the day and at home, states she then woke up in the early hours Thursday morning, 08Apr2021, states she had a headache, sweats, chills, that her arm did not bother her until this morning (09Apr2021), had upset stomach, the taste in her mouth was unbelievable, felt a little better, was improving, did not have much of an appetite and gait was a little off, but better. Asking if the 2nd dose will give her more side effects and if she could still get the 2nd shot because of the reactions. Caller wanted to know if she should have not gotten the vaccine since she had Covid last year. Outcome of the event sore arm, gait is off was not recovered; feeling sick was unknown; other events was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Arthritis in both right and left wrists; This is a spontaneous report from a contactable consumer, the patient. An 84-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 29Jan2021 at 12:00 (at the age of 84-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 20Feb2021 (at the age of 84-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), atorvastatin (MANUFACTURER UNKNOWN), tamsulosin hydrochloride (FLOWMAX) and metoprolol (MANUFACTURER UNKNOWN), all taken for an unspecified indication from an unknown date and unknown if ongoing. On 29Jan2021, the patient experienced arthritis in both right and left wrists. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event and included treatment with naproxen sodium (ALEVE). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arthritis in both right and left wrists was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Vertigo
Clinical narrative: Dizziness; Vertigo; Sweating 2-3 min after injectionLasted 1-2 min; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 14:45 (at the age of 27-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient did not receive any medications within two weeks of vaccination. On 09Apr2021 at 14:45, 2 to 3 minutes after the injection, the patient experienced dizziness, vertigo and sweating which lasted for 1 to 2 minutes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness, vertigo and sweating was recovered on 09Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity, Vomiting
Clinical narrative: extreme nausea; fatigue; Repeated vomiting beginning at approximately the 25th hour and continuing for the next several hours / was unable to keep food or liquid down for another approximate 24 hours thereafter.; Sharp pain in toes began within hours of first injection; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 18Mar2021 at 15:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Patient was not pregnant. Medical history included asthma and hypertension. The patient had no known allergies to medications, food or other products. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN), montelukast sodium (SINGULAIR) and hydrochlorothiazide (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. On 18Mar2021, the patient experienced sharp pain in toes began within hours of first injection. On 19Mar2021 at 16:30 (as reported), approximately 22hours from first injection the patient experienced extreme nausea and fatigue, followed by repeated vomiting beginning at approximately the 25th hour and continuing for the next several hours. The patient was unable to keep food or liquid down for another approximate 24 hours thereafter. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with ondansetron (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sharp pain in toes, nausea, fatigue and vomiting were recovered on unknown date in 2021. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 08Apr2021 at 15:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow up report is being submitted to amend previously reported information: added Vaccination Facility information, revised narrative to add "patient was not pregnant", removed dose 2 from suspect dose regimen.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Constipation, Dizziness, Fatigue, Ill-defined disorder
Clinical narrative: Dizzy; Congested; Upset stomach; Beginning of a migraine that did not develop; Fatigue; Constipation; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0151) via an unspecified route of administration in the right arm on 06Apr2021 at 15:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included menopause and osteopenia. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included estrogens conjugated (PREMARIN) and ibandronate sodium (IBANDRONATE); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6204) via an unspecified route of administration in the left arm on 16Mar2021 at 10:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. On 06Apr2021 at 22:00, the patient felt dizzy, congested, upset stomach, beginning of a migraine that did not develop, fatigue and constipation. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizzy, congested, upset stomach, beginning of a migraine that did not develop, fatigue and constipation was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Dizzy; Congested; Upset stomach; Beginning of a migraine that did not develop; Fatigue; Constipation; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0151) via an unspecified route of administration in the right arm on 06Apr2021 at 15:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included menopause and osteopenia. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included estrogens conjugated (PREMARIN) and ibandronate sodium (IBANDRONATE); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6204) via an unspecified route of administration in the left arm on 16Mar2021 at 10:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. On 06Apr2021 at 22:00, the patient felt dizzy, congested, upset stomach, beginning of a migraine that did not develop, fatigue and constipation. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizzy, congested, upset stomach, beginning of a migraine that did not develop, fatigue and constipation was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: Severe muscle pain on arm, shoulders; Severe muscle pain on arm, shoulders; Severe muscle pain on arm, shoulders; This is a spontaneous report from a contactable consumer or other non hcp. A 62-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: EWO150), via an unspecified route of administration on 04Apr2021 (at the age of 62-year-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 09Apr2021 the patient experienced severe muscle pain on arm, shoulders. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient did not receive any treatment for the adverse event. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a non-contactable consumer. A female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced fever after injection. The clinical outcome of the event fever after injection was unknown at the time of this report  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Updated primary reporter information, patient details (country) and added Vaccination Facility Country.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Sore arm, mild itching, both occurring at the injection site/Mild soreness at injection site (similar to flu shot), mild itching - nothing substantial; Sore arm, mild itching, both occurring at the injection site/Mild soreness at injection site (similar to flu shot), mild itching - nothing substantial; This is a spontaneous report from a contactable consumer or other non-healthcare professional.  A 50-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration, on 02Apr2021 09:30 AM (at the age of 50-year-old), in left arm as dose 1, single for COVID-19 immunization and also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735), via an unspecified route of administration, on 23Apr2021 09:45 AM (at the age of 50-year-old), in left arm as dose 2, single for COVID-19 immunization. Medical history included Colitis ulcerative from an unknown date and unknown if ongoing. Allergies to medications, food, or other products reported as none known. Concomitant medications included balsalazide taken for an unspecified indication, start and stop date were not reported and tylenol taken for an unspecified indication, on day of vaccination only. Patient did not taken any other vaccine in four weeks. Patient had not diagnosed with COVID-19 Prior to vaccination and patient had not been tested for COVID-19 Since the vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 02Apr2021 the patient experienced sore arm, mild itching, both occurring at the injection site/mild soreness at injection site (similar to flu shot), mild itching - nothing substantial. Same events occurred after prime and boost and with roughly same time course. Soreness first apparent about 5 hrs post-injection reaching peak about 10 hrs post-injection, persisted for about 2.5 days. Itching first noticed approx. 24 hrs post-injection, disappeared after about 2.5 days. Patient was taken 3 max strength Tylenol/day (spaced morning, afternoon, night) on day of and day after each injection to mitigate side effects. Mild soreness at injection site (similar to flu shot), mild itching nothing substantial, disappeared after 2-3 days, patient took tylenol max strength (1 pill before inoculation, 1 pill in afternoon, 1 pill in evening) to help reduce any potential side effects. Treatment was not taken for the reported adverse events. The clinical outcome of event was recovered on unspecified date 2021.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling of eyelid
Clinical narrative: Swelling of eyelids and cheekbones; Swelling of eyelids and cheekbones; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient first dose of received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6203) via an unspecified route of administration, administered in right arm on 05Apr2021 10:00 (at the age of 57-year-old) as dose 1, single for covid-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included diabettes from an unknown date and unknown if ongoing and known allergies to chicken, cigarette and smoke from an unknown date and unknown if ongoing. Allergies to medications, food, or other products: Alergia pollo, humo de cigarro. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 06:00, the patient experienced swelling of eyelids and cheekbones. No treatment received for the adverse event. Outcome of the event was not recovered at the time of reporting.    No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash macular
Clinical narrative: Red Spotted rash on feet, legs, trunk, arms, neck and scalp; Red Spotted rash on feet, legs, trunk, arms, neck and scalp; Red Spotted rash on feet, legs, trunk, arms, neck and scalp; Red Spotted rash on feet, legs, trunk, arms, neck and scalp; Red Spotted rash on feet, legs, trunk, arms, neck and scalp; This is a spontaneous report from a contactable consumer (patient himself). A 62-year-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8737) via an unspecified route, administered in Left arm on 08Apr2021 at 08:15 (62-year-old at vaccination) as Dose 2, Single for Covid-19 immunization.  The patient's medical history included hypothyroidism, Allergies to medications, food, or other products such as Amoxicillin. The patient's concomitant medications included sulfamethoxazole, trimethoprim oral tablet within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Prior vaccination, the patient was not diagnosed with Covid-19 and since the vaccination the patient had not been tested for Covid-19.  The patient previously received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EN6208) via an unspecified route administered in left arm on 18Mar2021 at 07:45 (62-year-old at vaccination) as Dose 1, Single for COVID-19 immunization. On 08Apr2021, patient experienced red spotted rash on feet, legs, trunk, arms, neck and scalp. The patient did not receive any treatment medication for the adverse event. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information was expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Off label use, Product use issue, Pyrexia, Vomiting
Clinical narrative: Very high fever (103.5); vomiting; Off label use; Drug use in unapproved population; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EP7533 and expiry date was not reported), via an unspecified route of administration, in Right Arm, on 09Apr2021 at 16:15 (at the age of 39-years-old), as dose 2, single dose for COVID-19 immunization. The patient's medical history included currently breast feeding. The patient had no known allergies to medications, food or other products. Concomitant medications included prenatal vitamins (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing for an unknown indication. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EP6955 and expiry date was not reported), via an unspecified route of administration, in Right Arm, on 17Mar2021 at 16:30 (at the age of 39-years-old), as dose 1, single dose for COVID-19 immunization. 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 receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 02:00, the patient experienced very high fever (103.5 UNSPECIFIED UNITS) and vomiting. It was not reported if the patient received any treatment for the re-ported events. There was an off label use and drug use in unapproved population as the patient had a maternal exposure during breast feeding since an un-known date in 2021. On 10Apr2021, the patient underwent body temperature measurement, and the result was found to be 103.5 (UNSPECIFIED UNITS). The events did not result in doctor or other healthcare professional office/clinic vis-it, emergency room/department or urgent care. The clinical outcome of the events very high fever (103.5), vomiting was recovering at the time of this re-port. The clinical outcome of the events off label use and drug use in unapproved population was unknown at the time of this report.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergies; This is a spontaneous report from a contactable consumer (patient). A 37-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration, administered in left arm on 10Apr2021 08:15 (at the age of 37 years) as dose 1, single for covid-19 immunization. Medical history included allergy to vancomycin, cherries, and seasonal allergies, from an unknown date and unknown if ongoing. Concomitant medications included vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]); and iron taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No covid prior vaccination and not covid tested post vaccination. The patient experienced allergies on 10Apr2021 08:30. Therapeutic measures were taken as a result of event and patient received unspecified treatment. The outcome of event was recovering.  Follow-up attempts completed. Information about lot/batch number cannot be obtained despite the follow-up attempts made. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin disorder
Clinical narrative: Rashes on left leg/rash beginning on his left leg, above the knee going up to the groin; Itchy and has little bumps and it goes from knees to up to the groin/getting worse and it is very itching; Itchy and has little bumps and it goes from knees to up to the groin; This is a spontaneous report received from a contactable consumer (patient's wife). A 77-years-old male patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number, Expiration date, NDC and UPC number was unknown) via an unspecified route of administration on 02Apr2021 (Friday night) as dose 1, single (at the age of 77-years-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Apr2021, Friday night, when he came home later, patient was very itchy, had little bumps and there was a rash beginning on his left leg, above the knee going up to the groin. Now, this reaction got worse yesterday (03Apr2021, Saturday) and it was worse today (04Apr2021, Sunday). Patient 's wife went to the store and brought some Cortisone cream, but the rash does not seem to be going away. And it was still very itching on it. Patient's wife stated that it seems to be getting worse and it was very itching. Patient's wife did not think at first that it had anything to do with the injection. Therapeutic measures were taken as a result of rash and itchy and treatment included cortisone cream. The outcome of rash and itchy was not recovered and unknown for had little bumps.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Fatigue
Clinical narrative: shortness of breath for 11 consecutive days; chest pain/ tightness; chest pain/ tightness; fatigue; This is a spontaneous report from a contactable patient or other non hcp (patient). A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported, Expiry Date: Unknown), dose 1 via an unspecified route of administration on 30Mar2021 (at the age of -years-old) as a DOSE  1, SINGLE for covid-19 immunisation at pharmacy. The patient medical history and concomitant medications were not reported.  On 30Mar2021, the patient experienced shortness of breath for 11 consecutive days, chest pain/ tightness and fatigue. Patient received first dose of vaccine on 30Mar2021. Patient reported that he was experiencing side effects such as shortness of breath for 11 consecutive days, fatigue and chest pain/ tightness. Worried about the second dose due to side effects he was experiencing.  Patient wanted to know if he should get second dose. Patient wanted to know if he does find that he is allergic to vaccine or has to wait to get second dose. Does he need to get two doses again in a year from now. Patient wanted know efficacy of vaccine after one dose. Patient stated, So, I am calling because I want to report some side effects that I have had received I was taking the vaccine of Pfizer (Unspecified Vaccine) on 30Mar2021 and I wanted to know if it is a good idea for me to actually take a second dosage because of the side effects I am presenting half last all this time and they have not gone away. PQC was not present. Outcome of all the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Biopsy, Hypersensitivity, Rash, Urticaria
Clinical narrative: I developed areas of  hives/rash over several parts of my body.; I developed areas of  hives/rash over several parts of my body.; Urticarial Hypersensitivity Reaction; This is a spontaneous report from a contactable nurse (patient) and physician. A 64-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EK9231), via an unspecified route of administration, administered in arm left on 09Jan2021 at 19:00 (07:00 PM) as, dose 1, single for COVID-19 immunization. Second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in arm left on 30Jan2021 at 04:00 PM as dose 2, single for COVID-19 immunization. Medical history was reported as none. Patient had no known allergies. The patients took dietary supplement within in two weeks of vaccination. The patient did not receive any other vaccine in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Jan2021, the patient experienced I developed areas of hives/rash over several parts of my body, urticarial hypersensitivity reaction. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Adverse event: I developed areas of hives/rash over several parts of my body. This began after the first vaccine (not immediately, days later) and became severe after the second vaccine dose. I saw my dermatologist DR. I also saw an allergist and had extensive allergy testing done. I eventually had a biopsy of the rash done. It showed Urticarial Hypersensitivity Reaction. It was reviewed by Dr. The patient underwent lab tests and procedures which included allergy testing was unknown; biopsy: urticarial hypersensitivity reaction. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient received treatment for the events. The outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Petechiae, Rash
Clinical narrative: Rash in both arms; Red-blurred petechiae that are so uniforms and skin looks very red; Red-blurred petechiae that are so uniforms and skin looks very red; This is a spontaneous report from a contactable consumer (patient) and other-health care professional. A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: Not Reported, Expiry Date: Not Reported), via an unspecified route of administration, administered in Arm right on 01Apr2021 16:15 (at the age of 46-year-old) as dose 1, single for covid-19 immunisation at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. The patient medical history concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient did not have any known allergies to medications, food, or other products. On 03Apr2021 at 14:00, the patient experienced rash on both arms, red-blurred petechiae that are so uniforms and skin looks very red. The patient did not receive any treatment for the reported adverse event. As per the reporter, the seriousness criteria of the reported events were non-serious. The event does not lead to any of the seriousness criteria such death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. Outcome of the event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: COVID-19, Malaise, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Fever; symptoms of COVID-19 infection/ tested for COVID-19 infection and the result was positive; This is a spontaneous report from a non-contactable consumer (patient's father). A 17-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) at the age of 17 years, as a single dose for vaccination. The patient's medical history and concomitant medications were not reported. The patient previously received meningococcal group b rlp2086 (TRUMENBA) on an unspecified date for vaccination. On 09Apr2021, 5 hours later, the patient developed fever and other symptoms of COVID-19 infection. The patient was tested for COVID-19 infection and the result was positive. The patient's father wanted to know if there was a cross reaction between the administration of the vaccine Trumenba and a COVID-19 laboratory test. He also wanted information about "if the vaccine Trumenba is given more than once to a 17-year-old patient." Outcome of the events was unknown.    No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Fatigue, Headache, Insomnia
Clinical narrative: tight chest/dry or tight chest a week after receiving the 1st dose; low grade fever; body ache; chills; headaches; exhaustion and insomnia at the same time; exhaustion and insomnia at the same time; This is a spontaneous report from a contactable consumer.   This female consumer (patient) of unspecified age reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on 03Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 10Apr2021, the patient experienced tight chest/dry or tight chest a week after receiving the 1st dose, low grade fever, body ache, chills, headaches, exhaustion and insomnia at the same time. It was great. She had no repercussions. On 10Apr2021, she had a low-grade fever, body ache, chills, headaches, exhaustion and insomnia at the same time and tight chest. It was a week later/after she got the vaccine. Her husband (age: 65) received the Pfizer vaccine, had it 2 weeks before. His side effects were within the first 3 days which was normal. When she got her shot and did not feel anything for a week. then wham, he was sleeping on his. He was tired. He had low grade fever and chills for 5 days. Mine was later. Her dad (age 94) also received the Pfizer vaccine. He did not have any side effects and he did not even feel the needle and 2nd shot (he got on the 10th) he felt the shot this time. So far so good. He was feeling great. She wants to know if it was normal to experience fever, headache, insomnia and dry or tight chest a week after receiving the 1st dose. She received the 1st dose last 03Apr2021 and 2nd dose will be on 24Apr2021. Provided contact number and hours of operation. Unaddressed medical questions referred or forwarded to Medical Information. Outcome was unknown for all the events.  Follow-up (12Apr2021): This is a follow-up spontaneous report from a contactable consumer reported verbatim and event description.  No follow up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: tight chest/dry or tight chest a week after receiving the 1st dose; low grade fever; body ache; chills; headaches; exhaustion and insomnia at the same time; exhaustion and insomnia at the same time; This is a spontaneous report from a contactable consumer.   This female consumer (patient) of unspecified age reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on 03Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 10Apr2021, the patient experienced tight chest/dry or tight chest a week after receiving the 1st dose, low grade fever, body ache, chills, headaches, exhaustion and insomnia at the same time. It was great. She had no repercussions. On 10Apr2021, she had a low-grade fever, body ache, chills, headaches, exhaustion and insomnia at the same time and tight chest. It was a week later/after she got the vaccine. Her husband (age: 65) received the Pfizer vaccine, had it 2 weeks before. His side effects were within the first 3 days which was normal. When she got her shot and did not feel anything for a week. then wham, he was sleeping on his. He was tired. He had low grade fever and chills for 5 days. Mine was later. Her dad (age 94) also received the Pfizer vaccine. He did not have any side effects and he did not even feel the needle and 2nd shot (he got on the 10th) he felt the shot this time. So far so good. He was feeling great. She wants to know if it was normal to experience fever, headache, insomnia and dry or tight chest a week after receiving the 1st dose. She received the 1st dose last 03Apr2021 and 2nd dose will be on 24Apr2021. Provided contact number and hours of operation. Unaddressed medical questions referred or forwarded to Medical Information. Outcome was unknown for all the events.  Follow-up (12Apr2021): This is a follow-up spontaneous report from a contactable consumer reported verbatim and event description.  No follow up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Severe headache; nausea; dizziness; joint pain; injection site swelling and redness; injection site swelling and redness; fatigue; fever; This is a spontaneous report received from contactable consumer (patient) reported for herself. A 44-year-old female patient received first dose of bnt162b2 (Pfizer COVID 19 vaccine, solution for injection, Lot number: ER8729), via an unspecified route on 08Apr2021 at 09:45 (age at vaccination: 44-year-old), as a single dose for covid-19 immunization. Medical history mentioned as none. The patient concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No allergies were reported. Patient received any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. On 09Apr2021 at 05:00, patient experienced severe headache, nausea, dizziness, joint pain, injection site swelling and redness, fatigue and fever. Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Severe headache; nausea; dizziness; joint pain; injection site swelling and redness; injection site swelling and redness; fatigue; fever; This is a spontaneous report received from contactable consumer (patient) reported for herself. A 44-year-old female patient received first dose of bnt162b2 (Pfizer COVID 19 vaccine, solution for injection, Lot number: ER8729), via an unspecified route on 08Apr2021 at 09:45 (age at vaccination: 44-year-old), as a single dose for covid-19 immunization. Medical history mentioned as none. The patient concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No allergies were reported. Patient received any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. On 09Apr2021 at 05:00, patient experienced severe headache, nausea, dizziness, joint pain, injection site swelling and redness, fatigue and fever. Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Muscular weakness
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), at the age of 61, via an unspecified route of administration, in left arm, on Mar 28, 2021, at 12:45, single dose, for COVID-19 immunisation. Medical history included diabetes and high cholesterol. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient previously took Zithromax Z-pack and experienced drug hypersensitivity. Other medications in two weeks reported as yes. On Mar 30, 2021, at 12:00, patient experienced muscles weakness, frequent chest pain and left arm weak/weakness in her left arm. No treatment received for the events. The outcome of the events: not recovered. No follow-up attempts possible. No further information expected.