chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Developed rash on my elbows first now all over my back, Trunck, both thigh buttock./ They are itchy and red; Itchy/ Developed rash on my elbows first now all over my back, Trunck, both thigh buttock./ They are itchy and red; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Jan2021 at 17:00(at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included cancer (reported as Cancer on medication). Concomitant medications included palbociclib (IBRANCE) and letrozole (MANUFACTURER UNKNOWN) for unknown indications from an unknown date. The patient had no known allergies to medications, food or other products. 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 09Feb2021 the patient developed rash on elbows first and now all over the back, trunk, both thigh buttock. They were itchy and red. 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. The clinical outcome of the events rash on elbows first and now all over the back, trunk, both thigh buttock, they were itchy and red was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymph node pain, Lymphadenopathy, Peripheral swelling, Spinal pain
Clinical narrative: About 48 hours after shot: sore, swollen lymph nodes, also stabbing pains in the lymph nodes (neck, armpits, left side of chest and groin); About 48 hours after shot: sore, swollen lymph nodes, also stabbing pains in the lymph nodes (neck, armpits, left side of chest and groin); About 24 hours after shot: swollen hands and feet but was gone by the second morning; The morning after: some joint pain, severe pain in spine but only lasted a couple of hours; The morning after: some joint pain, severe pain in spine but only lasted a couple of hours; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration in the left arm on 10Apr2021 at 13:15 (Lot Number: EW0150), at the age of 52-year-old, as a single dose for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included heart pounding/palpitations and migraine. The patient did not have any allergies to food, medications, or other products. Concomitant medications included propranolol, iron, ibuprofen, and unspecified multivitamin. 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 11Apr2021 at 06:30, the morning after, patient experienced some joint pain, severe pain in spine but only lasted a couple of hours. On 11Apr2021 at 13:15, about 24 hours after the shot, the patient experienced swollen hands and feet but was gone by the second morning. On 12Apr2021 at 13:15, about 48 hours after shot, the patient experienced sore, swollen lymph nodes, also stabbing pains in the lymph nodes (neck, armpits, left side of chest and groin). Therapeutic measures were taken as a result of some joint pain and severe pain in spine and included treatment with TYLENOL. No treatment was received for other events (swollen hands and feet; sore/stabbing pains in lymph nodes and swollen lymph nodes). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events some joint pain and severe pain in spine was recovered on 11Apr2021 (unspecified time). The clinical outcome of the event swollen hands and feet but was gone by the second morning was recovered on 12Apr2021. The clinical outcome of the events sore, swollen lymph nodes, also stabbing pains in the lymph nodes (neck, armpits, left side of chest and groin) was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph nodes on the left side swelled up; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown) via an unspecified route of administration in the right  arm on 09Apr2021(at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, diabetes, sleep apnea and COVID-19. Concomitant medications were not reported. The patient had known allergy to horse serum/tetanus, The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown) via an unspecified route of administration in the left  arm on 16Mar2021 at 10:30 (at the age of 55-year-old) as a single dose for COVID-19 immunisation.  The patient previously took Alka-Seltzer plus cold medicine, MSG for an unknown indication and experienced allergy. Prior to the vaccination, the patient was 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 12Apr2021 the patient experienced lymph nodes on the left side swelled up. Therapeutic measures were not taken as a result of these events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event lymph nodes on the left side swelled up was recovering at the time of this report.   No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Hypoaesthesia oral, Pruritus
Clinical narrative: facial numbness; Itching/itching on arms and legs; Her mouth is also numb; driving her crazy; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8732) via an unspecified route of administration, administered in Arm Left on 12Apr2021 at 08:00 (at the age of 54-year-old) as dose 2, single for COVID-19 immunisation. Patient's medical history (including any illness at time of vaccination) was none. Concomitant medication(s) included vitamin d nos (VITAMIN D) taken for an unspecified indication, start and stop date were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER2613, NDC and expiry are not provided) via an unspecified route of administration, administered in Arm Left on 22Mar2021 (at the age of 54 years old) as single for COVID-19 immunisation. Additional vaccines administered on same date of the pfizer suspect was none. The patient experienced facial numbness, Itching/itching on arms and legs, her mouth is also numb, driving her crazy on 12Apr2021. Reported as, Her face from the forehead down to her lips are numb. Her mouth was also numb. She feels like she has been to the dentist. It was driving her crazy. She was also itching on her arms and legs. Numbness started about 45 minutes after the vaccine followed by itching around 11:00 am. Outcome of all the events were not recovered.  No follow-up attempts are needed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female 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 left on 04Mar2021 at 10:30(at the age of 68-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and diverticulitis from unknown dates and unknown if ongoing. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN), celecoxib (CELEBREX) and lorazepam (ATIVAN); all from unknown date for an unspecified indication. The patient had no known allergies to medications, food or other products. Prior to 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 05Mar2021 at 12:00 the patient experienced Heart palpitations. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event Heart palpitations was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Palpitations, Peripheral swelling, SARS-CoV-2 test, Swelling face
Clinical narrative: Swelling of face; Heart palpitations; Pain at the joints of wrist, elbow, and shoulder which is the opposite of injection site; Hand swelling; Swelling of bilateral feet; This is a spontaneous report from a contactable nurse. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 10:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any medication within two weeks of vaccination. The patient previously took Amoxicillin and experienced drug allergy. 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. On 06Apr2021 the patient experienced swelling of right side of face, heart palpitations, pain in joints of wrist, elbow and shoulder which is opposite of injection site, bilateral feet and hand swelling. No therapeutic measures were taken as a result of the events. The events resulted in emergency room/department or urgent care. On 08Apr2021, the patient underwent nasal swab test and the result was negative. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swelling of right side of face, heart palpitations, pain in joints of wrist, elbow and shoulder which is opposite of injection site, bilateral feet and hand swelling was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Headache; Fatigue; Nausea; Vomiting; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 08Apr2021 at 10:45 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any other medications in two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 18Mar2021 at 09:30 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 14:00, the patient experienced headache, fatigue, nausea, vomiting, chills and fever. 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. The clinical outcome of the events headache, fatigue, nausea, vomiting, chills and fever were resolved on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache; Fatigue; Nausea; Vomiting; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 08Apr2021 at 10:45 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any other medications in two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 18Mar2021 at 09:30 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 14:00, the patient experienced headache, fatigue, nausea, vomiting, chills and fever. 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. The clinical outcome of the events headache, fatigue, nausea, vomiting, chills and fever were resolved on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I started having nightly headaches exactly 36 hours after the second dose vaccine.  It happened every night for five days followed by every other night until now.; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old, male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955/ER8733) via an unspecified route of administration in the left arm on 26Mar2021 at 10:00 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. No relevant medical history reported. The patient reported of no known allergies to medications, food, or other products. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 05Mar2021 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 at 21:00, the patient experienced nightly headaches exactly 36 hours after the second dose of the vaccine. The patient reported that it happened every night for five days followed by every other night until now. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the event started having nightly headaches exactly 36 hours after the second dose vaccine was resolving.   No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Allergic reaction; hives; This is a spontaneous report from a contactable consumer, the patient, received through the agency. A 29-year-old [non-pregnant] adult female received the second dose of intramuscular BNT162B2 (solution for injection, Lot unknown expiry information not provided) as a single dose in the left arm on 06Apr2021 at 14:00 (at 29-years-old) for COVID-19 immunization. Relevant medical history included Anaphylaxis, Polycystic ovarian syndrome (PCOS), and known [unspecified] allergies. Concomitant medications included drospirenone, ethinylestradiol betadex clathrate (YAZ); escitalopram oxalate (LEXAPRO); metformin; cetirizine hydrochloride (ZYRTEC); vitamin D NOS; and cyanocobalamin (VITAMIN B 12). The patient denied any diagnosis of COVID prior to receiving the vaccine and the patient was not pregnant at the time of vaccine. The patient denied being tested for COVID-19 since receiving the vaccine. The patient previously received COVID-19 immunization with the first dose of intramuscular BNT162B2 (solution for injection, Lot unknown expiry information not provided) as a single dose in the right arm on 16Mar2021 at 13:00 (at 29-years-old). The patient reported that on 06Apr2021 at 17:00 she experienced an allergic reaction including hives; which resulted in a visit to an emergency room/department or urgent care. Treatment for the events included intravenous steroids and oral steroids for six days after, as well as diphenhydramine hydrochloride (BENADRYL). The outcome of the events Allergic reaction including hives was recovering.   Information on batch/lot number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Road traffic accident
Clinical narrative: Bike accident; This is a spontaneous report from a contactable other healthcare professional (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left rm on 20Mar2021 14:30 (Batch/Lot Number: ER2613), at the age of 45 years old, as dose 1, single for covid-19 immunisation in a public health clinic/veterans administration facility. The patient's medical history was not reported. No known allergies. No covid prior to vaccination and was not covid tested post vaccination. Concomitant medication included cefalexin (CEPHALEXINE) taken for an unspecified indication, start and stop date were not reported. On 08Apr2021 13:00, the patient experienced bike accident. The event resulted in emergency room/department or urgent care. Treatment included stitches. The patient received tetanus shot on 08Apr2021 in left arm. The patient was recovering from the event. The patient received dose 2 of Pfizer COVID 19 vaccine on 10Apr2021 15:15 in right arm.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Road traffic accident and the suspect drug bnt162b2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Significant rash at waist on left and right sides above legs; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 07Apr2021 at 15:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and shingles, both since unknown dates and for unknown durations. The patient previously took codeine (MANUFACTURER UNKNOWN) for an unknown indication and experienced drug allergy. Concomitant medications included metformin (MANUFACTURER UNKNOWN), atorvastatin calcium (LIPITOR), losartan (MANUFACTURER UNKNOWN), lansoprazole (MANUFACTURER UNKNOWN), and acetylsalicylic acid (ASPRIN); all for an unknown indication and since unknown dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021 at 00:15 the patient experienced a significant rash at the waist on the left and right sides above the legs, which was similar to when he had shingles. The event 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 reported event. The clinical outcome of the event significant rash at the waist on the left and right sides above legs was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Product preparation issue
Clinical narrative: The vial was not diluted properly, it was only diluted with 0.8mls; The vial was not diluted properly, it was only diluted with 0.8mls; This is a spontaneous report from a non-contactable pharmacist. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an intramuscular route of administration in the left arm on 09Apr2021 (at the age of 17-year-old) as a 0.3 ml single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies to medications, food or other products. It was unknown if the patient received any medication within two weeks of vaccination. 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, the patient was given a dose of 0.3 ml but the vial was not diluted properly, it was only diluted with 0.8mls.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on chest, stomach, back and legs; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 06Apr2021 at 15:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included losartan (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 16Mar2021 at 16:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient previously received azithromycin (ZITHROMAX) on an unknown date and experienced drug allergy. 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 09Apr2021 at 07:00, the patient experienced rash on chest, stomach, back and legs. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event rash on chest, stomach, back and legs was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: I started to feel dizzy and feel very lethargic two days after the covid vaccine, Pfizer, 1st shot. It has been 12 days and am still dizzy.; The fatigues and low energy are still continued.; The fatigues and low energy are still continued; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 30Mar2021 at 10:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included joint inflammation and backache. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), Multivitamins (MANUFACTURER UNKNOWN), Probiotics (MANUFACTURER UNKNOWN) and omega-3 NOS (OMEGA-3) from an unknown date and for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Vicodin for an unknown indication on an unknown date and experienced drug allergy. 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 01Apr2021, the patient experienced to feel dizzy and feel very lethargic two days after the covid vaccine, Pfizer, 1st shot. Even after 12 days she was still dizzy. The fatigues and low energy are still continued. The dizziness was mild to moderate still able to do daily chores but with low energy. Due to being dizzy she avoided driving or walking outside. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events dizzy and feel very lethargic two days after the covid vaccine, Pfizer, 1st shot. Even after 12 days she was still dizzy. The fatigues and low energy are still continued. The dizziness was mild to moderate still able to do daily chores but with low energy were not resolved at the time of report.  No follow up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Ear pain, Feeling abnormal, Headache, Hypoaesthesia oral
Clinical narrative: Enlarged throat tonsils, white spots on tonsils that looked like strep; Al delayed. Arm soreness/Thigh soreness; Al delayed. Arm soreness/Thigh soreness; rash; blisters on fingers; Headaches in back of head; Ear aches, both sides; numb lips; Overwhelming feeling of doom; lymph nodes enlarged; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162B2, via an unspecified route of administration, administered in Arm Left on 31Mar2021 08:30 (Lot Number: ER8737), at the age of 39-year-old, as dose 1, single for COVID-19 immunization. Medical history included asthma, mild COPD, allergies to strawberries, allergy to penicillin, allergy to dogs and allergy to bees, all from an unknown date and unknown if ongoing. Concomitant medications included salbutamol sulfate (PROAIR DIGIHALER) taken for an unspecified indication, start and stop date were not reported. On 31Mar2021 17:00, the patient experienced Enlarged throat tonsils, white spots on tonsils that looked like strep, AI delayed, arm soreness/thigh soreness, rash, blisters on fingers, headaches in back of head, ear aches both sides, numb lips, overwhelming feeling of doom and lymph nodes enlarged. Events resulted in Doctor or other healthcare professional office/clinic visit nd Emergency room/department or urgent care. The patient was not pregnant at the time of vaccination. 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. The patient underwent lab tests and procedures which included COVID Test (Nasal Swab): negative both on 03Apr2021 and on 12Apr2021. Therapeutic measures were taken as a result of all events and included steroids and an antibiotic in case of infection. The outcome of the events was not recovered.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Pharyngitis streptococcal, Rash, SARS-CoV-2 test
Clinical narrative: Enlarged throat tonsils, white spots on tonsils that looked like strep; Al delayed. Arm soreness/Thigh soreness; Al delayed. Arm soreness/Thigh soreness; rash; blisters on fingers; Headaches in back of head; Ear aches, both sides; numb lips; Overwhelming feeling of doom; lymph nodes enlarged; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162B2, via an unspecified route of administration, administered in Arm Left on 31Mar2021 08:30 (Lot Number: ER8737), at the age of 39-year-old, as dose 1, single for COVID-19 immunization. Medical history included asthma, mild COPD, allergies to strawberries, allergy to penicillin, allergy to dogs and allergy to bees, all from an unknown date and unknown if ongoing. Concomitant medications included salbutamol sulfate (PROAIR DIGIHALER) taken for an unspecified indication, start and stop date were not reported. On 31Mar2021 17:00, the patient experienced Enlarged throat tonsils, white spots on tonsils that looked like strep, AI delayed, arm soreness/thigh soreness, rash, blisters on fingers, headaches in back of head, ear aches both sides, numb lips, overwhelming feeling of doom and lymph nodes enlarged. Events resulted in Doctor or other healthcare professional office/clinic visit nd Emergency room/department or urgent care. The patient was not pregnant at the time of vaccination. 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. The patient underwent lab tests and procedures which included COVID Test (Nasal Swab): negative both on 03Apr2021 and on 12Apr2021. Therapeutic measures were taken as a result of all events and included steroids and an antibiotic in case of infection. The outcome of the events was not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Polymenorrhoea
Clinical narrative: Rapid heart rate for 48 hours; Shortness of breath; Menstrual cycle day 2 when got vaccineand it stopped that night; This is a spontaneous report from a contactable healthcare professional, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 15:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included Severe Acute Respiratory Syndrome (SARS) prior to 4 years. The patient had no allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to 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 30Mar2021 at 15:30, the patient experienced rapid heart rate for 48 hours and shortness of breath. The patient was on the second day of menstrual cycle and it had stopped that night. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events rapid heart rate was resolved on 01Apr2021, while that of shortness of breath and shortened menstrual cycle were resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Severe pain in left shoulder; Pain in left hip; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 08Mar2021 at 13:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included malignant neoplasm of rectum and finished chemo for cancer in Jun2020. The patient did not have allergies to medications, food or other products. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN) all for unknown indications from an unknown date and unknown if ongoing. 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. On 08Mar2021, the same day of vaccination,  the patient experienced, severe pain in her left shoulder and left hip and the pain was so intense she couldn't move properly and could not lay on left side for about 4 weeks from first shot. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe pain in her left shoulder and left hip was recovering at the time of this report. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 05Apr2021 at 13:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever(mild); body pains(moderate); headache(moderate); chills(Severe); nausea(mild); This is a spontaneous report from a contactable consumer, the patient. A 38-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 11Apr2021 at 18:00(at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included covid-19. The patient did not receive any medication within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Apr2021 the patient experienced exact same symptoms after receiving the shot when he had a Covid in august, like fever(mild), body pains(moderate), headache(moderate), chills (Severe), nausea(mild). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever(mild), body pains(moderate), headache(moderate), chills (Severe), and nausea(mild) were not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Headache, Herpes zoster, Pain in jaw
Clinical narrative: Oral shingles; ear/jaw aches; ear/jaw aches; Chills; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 70-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Ew0150 or cw0150) via an unspecified route of administration on 05Apr2021 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medication included levothyroxine (MANUFACTURER UNKNOWN) from an unknown date and for an unknown indication. Prior to 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 an unknown date in Apr2021, the patient experienced oral shingles, chills, headache and ear/jaw aches. The adverse events resulted 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 reported events which included treatment with valacyclovir from an unknown date. The clinical outcome of the event oral shingles, chills, headache and ear/jaw aches were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: First vaccine was received while menstruating, menstruation lasted for 5 days past normal; This is a spontaneous report from a contactable consumer (patient). A 26-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EP7534), via an unspecified route of administration, administered in Arm Left on 17Mar2021 at 10:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history reported as None. There were no concomitant medications reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. No allergies to medications, food, or other products. On an unspecified date in Mar2021, the patient experienced first vaccine was received while menstruating, menstruation lasted for 5 days past normal. No treatment received for the adverse event. The outcome of event was recovered on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dysphonia, Dyspnoea
Clinical narrative: little trouble taking a deep breath; voice is hoarse; a bit tightness in my chest; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 08:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient had not been 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, the patient experienced a little trouble while taking a deep breath, her voice was hoarse, a little bit hard to take a breath and also felt a bit tightness in her chest upon waking a couple of times. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events trouble while taking a deep breath, voice was hoarse and tightness in her chest were not resolved at this time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Joint injury, Pyrexia
Clinical narrative: fever; ankles hurt; This is a spontaneous report from a contactable consumer or other non-Hcp. This Contactable consumer reported for an unknown male patient. A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Lot number: Unknown, Expiry date: Unknown) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever and ankles hurt on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased, Decreased appetite, Fatigue
Clinical narrative: Extreme fatigue; Loss of appetite; Low blood sugar; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female 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 left on 31Mar2021 at 18:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 with unknown start date and end date. The patient had no known allergies. Concomitant medications included buspirone (MANUFACTURER UNKNOWN) and ethinylestradiol, levonorgestrel (LOSEASONIQUE) on unknown date for an unspecified indication. Prior to the vaccination, the patient was 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 03Apr2021 at 09:00 the patient experienced extreme fatigue, loss of appetite and low blood sugar. Therapeutic measures were not taken as a result of these events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event extreme fatigue, loss of appetite and low blood sugar was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: 1 hour post vaccine menstruation immediately stopped 4 days early; This is a spontaneous report from a contactable consumer. This 26-Years-Old female consumer (patient) reported that:   A 26-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP8735), via intramuscular route of administration administered in Arm Left on 07Apr2021 (at the age of 26-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 07Apr2021, the patient experienced 1 hour post vaccine menstruation immediately stopped 4 days early. The clinical outcome of event was recovered on unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Pretty severe body aches; Fatigue; Headache; This is a spontaneous report from a contactable nurse, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 09Apr2021 at 10:15 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included depression, anxiety, gastroesophageal reflux disease (GERD), migraine and COVID-19. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), propranolol (MANUFACTURER UNKNOWN), buspirone hydrochloride (BUSPAR), omeprazole (MANUFACTURER UNKNOWN) and cynara cardunculus; malus spp. vinegar extract; taraxacum officinale (apple cider) (MANUFACTURER UNKNOWN), all used for unknown indication and from an unknown date. The patient previously took morphine and Norco and experienced allergy to the drugs. Prior to vaccination, the patient was 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 11:00, the patient experienced pretty severe body aches, 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. The clinical outcome of the events pretty severe body aches, fatigue and headache was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Myalgia, Nausea
Clinical narrative: Very severe headache; Extreme muscle aches; Extreme stomach ache; Nausea; This is a spontaneous report from a contactable consumer, the patient. An elderly non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 09Apr2021 at 19:00 as a single dose for COVID-19 immunisation. The patient's medical history included tuberculosis, the patient reported that she had come in contact with the tuberculosis (at the age of 13) and the tuberculosis became active at the age of 23 when the patient was in college and working and she had recovered with "scare tissue in the lungs". The patient also had high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included losartan (MANUFACTURER UNKNOWN) taken once a day from an unknown date for high blood pressure. The patient previously received atenolol and experienced a drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left am on 19Mar2021 at 18:30 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 10Apr2021 at 10:00, the patient experienced very severe headache (8 hours), extreme muscle aches, extreme stomach ache and nausea so bad that the patient almost went to the local emergency room. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events very severe headache, extreme muscle aches, extreme stomach ache and nausea were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: had numbness in my right hand for 2 days; This is a spontaneous report received from contactable consumer or other non health care professional by Pfizer from product quality complaint.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and Expiration date: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, after vaccination, the patient had numbness in right hand for 2 days. The clinical outcome of event was unknown.   Information about lot/batch number cannot be obtained. No follow-up attempts are needed. No further information is expected.