chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Blood thyroid stimulating hormone, Blood thyroid stimulating hormone increased, Body temperature, Fatigue
Clinical narrative: body aches; 101.9 fever; significant swollen glands on R side of neck; significant swollen glands on R side of neck with pain; sleep was interrupted; low grade fever; fatigue; 4 lb weight loss; elevated TSH; lymph/thyroid swelling; 2 nodules on the thyroid; This is a spontaneous report from a contactable other hcp. A elderly Non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6200, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 01Mar2021 09:30 as dose 2, single for covid-19 immunisation. Medical history included Thyroiditis 25 years ago, inc BP, inc cholesterol, hypothyroid. Concomitant medication(s) included atorvastatin (ATORVASTATIN); levothyroxine (LEVOTHYROXINE); lisinopril (LISINOPRIL). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 06Feb2021 as dose 1, single for covid-19 immunisation and experienced 16 days after first Pfizer vaccine on 06Feb2021 developed swelling on L side of neck, Tenderness over thyroid mid and L side. 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. Patient visited doctor or other healthcare professional office/clinic visit. On 13Mar2021 the patient experienced in L arm with body aches, 101.9 fever, significant swollen glands on r side of neck with pain to palpation particularly over R thyroid, sleep was interrupted, low grade fever, fatigue, 4 lb weight loss, elevated tsh, lymph/thyroid swelling, 2 nodules on the thyroid. she was following up with an endocrinologist. her symptoms cleared up in approximately 8 days start to finish. The patient underwent lab tests and procedures which included blood thyroid stimulating hormone was elevated, ultrasound thyroid was lymph/thyroid swelling, Fever 101.9, Fever was low grade fever, weight was 4 lb weight loss, Blood work result unknown. Patient received treatment of OTC meds, blood work and ultrasound. The outcome of event was lymph/thyroid swelling was unknown, rest of all events was recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck pain, Pain, Pyrexia, Sleep disorder
Clinical narrative: body aches; 101.9 fever; significant swollen glands on R side of neck; significant swollen glands on R side of neck with pain; sleep was interrupted; low grade fever; fatigue; 4 lb weight loss; elevated TSH; lymph/thyroid swelling; 2 nodules on the thyroid; This is a spontaneous report from a contactable other hcp. A elderly Non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6200, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 01Mar2021 09:30 as dose 2, single for covid-19 immunisation. Medical history included Thyroiditis 25 years ago, inc BP, inc cholesterol, hypothyroid. Concomitant medication(s) included atorvastatin (ATORVASTATIN); levothyroxine (LEVOTHYROXINE); lisinopril (LISINOPRIL). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 06Feb2021 as dose 1, single for covid-19 immunisation and experienced 16 days after first Pfizer vaccine on 06Feb2021 developed swelling on L side of neck, Tenderness over thyroid mid and L side. 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. Patient visited doctor or other healthcare professional office/clinic visit. On 13Mar2021 the patient experienced in L arm with body aches, 101.9 fever, significant swollen glands on r side of neck with pain to palpation particularly over R thyroid, sleep was interrupted, low grade fever, fatigue, 4 lb weight loss, elevated tsh, lymph/thyroid swelling, 2 nodules on the thyroid. she was following up with an endocrinologist. her symptoms cleared up in approximately 8 days start to finish. The patient underwent lab tests and procedures which included blood thyroid stimulating hormone was elevated, ultrasound thyroid was lymph/thyroid swelling, Fever 101.9, Fever was low grade fever, weight was 4 lb weight loss, Blood work result unknown. Patient received treatment of OTC meds, blood work and ultrasound. The outcome of event was lymph/thyroid swelling was unknown, rest of all events was recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Thyroid mass, Ultrasound thyroid, Weight, Weight decreased
Clinical narrative: body aches; 101.9 fever; significant swollen glands on R side of neck; significant swollen glands on R side of neck with pain; sleep was interrupted; low grade fever; fatigue; 4 lb weight loss; elevated TSH; lymph/thyroid swelling; 2 nodules on the thyroid; This is a spontaneous report from a contactable other hcp. A elderly Non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6200, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 01Mar2021 09:30 as dose 2, single for covid-19 immunisation. Medical history included Thyroiditis 25 years ago, inc BP, inc cholesterol, hypothyroid. Concomitant medication(s) included atorvastatin (ATORVASTATIN); levothyroxine (LEVOTHYROXINE); lisinopril (LISINOPRIL). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 06Feb2021 as dose 1, single for covid-19 immunisation and experienced 16 days after first Pfizer vaccine on 06Feb2021 developed swelling on L side of neck, Tenderness over thyroid mid and L side. 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. Patient visited doctor or other healthcare professional office/clinic visit. On 13Mar2021 the patient experienced in L arm with body aches, 101.9 fever, significant swollen glands on r side of neck with pain to palpation particularly over R thyroid, sleep was interrupted, low grade fever, fatigue, 4 lb weight loss, elevated tsh, lymph/thyroid swelling, 2 nodules on the thyroid. she was following up with an endocrinologist. her symptoms cleared up in approximately 8 days start to finish. The patient underwent lab tests and procedures which included blood thyroid stimulating hormone was elevated, ultrasound thyroid was lymph/thyroid swelling, Fever 101.9, Fever was low grade fever, weight was 4 lb weight loss, Blood work result unknown. Patient received treatment of OTC meds, blood work and ultrasound. The outcome of event was lymph/thyroid swelling was unknown, rest of all events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fall, Fatigue, Feeling abnormal
Clinical narrative: nausea; dizzy; fell; hit my head; fever; lymph node in neck very swollen and painful; lymph node in neck very swollen and painful; fatigue; brain fog; chills; body aches; This is a spontaneous report from a contactable consumer or other non hcp.     A 32-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: ER8729), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 11:30 as dose 2, single for covid-19 immunisation. Medical history included. Concomitant medication(s) included potassium (POTASSIUM); escitalopram oxalate (ESCITAL); loratadine (CLARITINE). Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, on 16Mar2021 07:15 PM (Batch/Lot Number was EN68207) as single dose for covid-19 immunisation.It was Reported that, The patient experienced chills, body aches 13Apr2021 13:00 with outcome of not recovered, brain fog on 15Apr2021 with outcome of recovered , fatigue on 16Apr2021 with outcome of not recovered, fever, lymph node in neck very swollen and painful, lymph node in neck very swollen and painful on 21Apr2021 with outcome of not recovered , nausea, dizzy, fell, hit my head on 22Apr2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 23Apr2021 Nasal Swab. Therapeutic measures were taken as a result of chills (chills), body aches (pain), brain fog (feeling abnormal), fatigue (fatigue), fever (pyrexia), lymph node in neck very swollen and painful (lymphadenopathy), lymph node in neck very swollen and painful (lymph node pain), nausea (nausea), dizzy (dizziness), fell (fall) hit my head (head injury).  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Head injury, Lymph node pain, Lymphadenopathy, Nausea, Pain
Clinical narrative: nausea; dizzy; fell; hit my head; fever; lymph node in neck very swollen and painful; lymph node in neck very swollen and painful; fatigue; brain fog; chills; body aches; This is a spontaneous report from a contactable consumer or other non hcp.     A 32-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: ER8729), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 11:30 as dose 2, single for covid-19 immunisation. Medical history included. Concomitant medication(s) included potassium (POTASSIUM); escitalopram oxalate (ESCITAL); loratadine (CLARITINE). Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, on 16Mar2021 07:15 PM (Batch/Lot Number was EN68207) as single dose for covid-19 immunisation.It was Reported that, The patient experienced chills, body aches 13Apr2021 13:00 with outcome of not recovered, brain fog on 15Apr2021 with outcome of recovered , fatigue on 16Apr2021 with outcome of not recovered, fever, lymph node in neck very swollen and painful, lymph node in neck very swollen and painful on 21Apr2021 with outcome of not recovered , nausea, dizzy, fell, hit my head on 22Apr2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 23Apr2021 Nasal Swab. Therapeutic measures were taken as a result of chills (chills), body aches (pain), brain fog (feeling abnormal), fatigue (fatigue), fever (pyrexia), lymph node in neck very swollen and painful (lymphadenopathy), lymph node in neck very swollen and painful (lymph node pain), nausea (nausea), dizzy (dizziness), fell (fall) hit my head (head injury).  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: nausea; dizzy; fell; hit my head; fever; lymph node in neck very swollen and painful; lymph node in neck very swollen and painful; fatigue; brain fog; chills; body aches; This is a spontaneous report from a contactable consumer or other non hcp.     A 32-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: ER8729), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 11:30 as dose 2, single for covid-19 immunisation. Medical history included. Concomitant medication(s) included potassium (POTASSIUM); escitalopram oxalate (ESCITAL); loratadine (CLARITINE). Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, on 16Mar2021 07:15 PM (Batch/Lot Number was EN68207) as single dose for covid-19 immunisation.It was Reported that, The patient experienced chills, body aches 13Apr2021 13:00 with outcome of not recovered, brain fog on 15Apr2021 with outcome of recovered , fatigue on 16Apr2021 with outcome of not recovered, fever, lymph node in neck very swollen and painful, lymph node in neck very swollen and painful on 21Apr2021 with outcome of not recovered , nausea, dizzy, fell, hit my head on 22Apr2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 23Apr2021 Nasal Swab. Therapeutic measures were taken as a result of chills (chills), body aches (pain), brain fog (feeling abnormal), fatigue (fatigue), fever (pyrexia), lymph node in neck very swollen and painful (lymphadenopathy), lymph node in neck very swollen and painful (lymph node pain), nausea (nausea), dizzy (dizziness), fell (fall) hit my head (head injury).  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Disorientation, Eating disorder, Influenza like illness
Clinical narrative: Severe flu-like symptoms; Unable to keep down food or water; Disoriented; Severe dehydration; Vomiting; Shivering violently; This is a spontaneous report from a non-contactable consumer or other non hcp (Patient).  A 30-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTEH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on an unspecified date as single dose for COVID-19 immunization. Medical history included asthma, depression, allergies to eggplant, kiwi all from an unknown date and unknown if ongoing. Concomitant medication included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN) both taken for an unspecified indication, start and stop date were not reported. patient previously took amoxicillin and experienced drug hypersensitivity. Historical Vaccine included first dose of bnt162b2 on 31Mar2021 for covid-19 immunization. Patient did not receive other vaccine in four weeks. Patient was not diagnosed with covid prior to vaccination. It was reported that exactly 12 hrs after second shot began severe flu-like symptoms: shivering violently and vomiting. Lasted for approximately 14 hours, severe dehydration, unable to keep down food or water. Moderate flu-like symptoms lasted for 2 days and disoriented for about a week. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment for the events. Patient was not tested for covid post vaccination. The outcome for the events was reported as resolved on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Severe flu-like symptoms; Unable to keep down food or water; Disoriented; Severe dehydration; Vomiting; Shivering violently; This is a spontaneous report from a non-contactable consumer or other non hcp (Patient).  A 30-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTEH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on an unspecified date as single dose for COVID-19 immunization. Medical history included asthma, depression, allergies to eggplant, kiwi all from an unknown date and unknown if ongoing. Concomitant medication included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN) both taken for an unspecified indication, start and stop date were not reported. patient previously took amoxicillin and experienced drug hypersensitivity. Historical Vaccine included first dose of bnt162b2 on 31Mar2021 for covid-19 immunization. Patient did not receive other vaccine in four weeks. Patient was not diagnosed with covid prior to vaccination. It was reported that exactly 12 hrs after second shot began severe flu-like symptoms: shivering violently and vomiting. Lasted for approximately 14 hours, severe dehydration, unable to keep down food or water. Moderate flu-like symptoms lasted for 2 days and disoriented for about a week. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment for the events. Patient was not tested for covid post vaccination. The outcome for the events was reported as resolved on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Hypersensitivity
Clinical narrative: Allergy; Considerable hair loss; This is a spontaneous report from a contactable consumer (herself as patient). A 72-years-old non-pregnant female patient received the first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection) (Age at vaccination: 72-years-old) via an unspecified route of administration, administered in Arm Right on 02Apr2021 08:45 (Lot number: ER8727, Expiry date: Unknown) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included chronic lymphocytic leukaemia, heart disease, cholesterol, blood pressure and stent implanted (I just recently had a stent implanted last week Heart Catheterization); all from an unknown date and unknown if ongoing. The patient had known allergies. Concomitant medications included atorvastatin calcium at 80 mg unknown frequency, omeprazole, acetylsalicylic acid (BABY ASPIRIN), prasugrel, hydrochlorothiazide, lisinopril and vitamin d3 (2000 unites); all taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior and received other medications 2 weeks prior to the COVID-19 vaccine. The patient was tested positive for COVID-19 prior to vaccination and had not been tested post vaccination. On 14Apr2021, the patient experienced considerable hair loss and allergy on an unspecified date. She was currently receiving IVIG which is an Immunoglobulin infusion that I get on monthly basis for my Chronic Lymphocytic Leukemia and she just wondering she had a schedule to get a shot in two days her second one and schedule to do her IVIG two days later. She just recently had a stent implanted last week Heart Catheterization. She on blood thinner, Cholesterol medicine, blood pressure. Therapeutic measures were taken as a result of allergy and no treatment was taken for alopecia. The outcome of the event alopecia was not recovered and for another event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, COVID-19, Fatigue, Swelling
Clinical narrative: Fatigue; Neck was super swollen on one side; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient's wife).    A 37-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8734 or EK8734) via an unspecified route of administration, administered in Arm Right on 10Apr2021 12:00 (at the age of 37 years) as dose 1, single for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. Family Medical History included the main concern was that her husband's mother had a heart attack in her 50s and his paternal grandpa died of hardening of arteries when he was 32 years old, so that is why the doctors did a full work up on the heart attack to make sure her husband was completely good there. On an unspecified date in Apr2021 after receiving first dose of vaccine the patient experienced fatigue which lasted for 3 to 4 days, neck was super swollen on one side which lasted for a week and alter ended to visit emergency room and physician visit. Reporter stated the lot number for the first dose of the vaccine is either ER8734 or EK8734, she can't read the person's handwriting on the vaccine record card. Reporter stated the only thing she wanted to note was back in Feb2021 her husband thought he could have had COVID, he wasn't sure so he went to get tested. However, his COVID test results were lost so he never got the test results. She wanted to add that in because she knows if her husband had COVID that could effect things, but he has been feeling fine ever since February. Reporter stated after the first COVID 19 vaccine, her husband was pretty much out of it, like completely out of it. She was concerned and was like "are you going to wake up today?". The fatigue was very real and then his neck was super swollen on one side. That was the only side effects from the first one, it was nothing horrible. She confirms the fatigue was either 2 or 3 days after her husband received the first dose of the vaccine and it lasted a good 3 to 4 days where he was beyond fatigued. His neck being super swollen started pretty soon after the first dose, either the next day or 2 days later and lasted for a week or so. She knows it was really sore when he touched it. The patient underwent lab tests and procedures which included blood clot test was normal on an unknown date, COVID-19: test results were lost on Feb2021. Therapeutic measures were taken as a result of fatigue, neck was super swollen on one side. The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021503792 same patient and reporter, different dose and event.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Condition aggravated, Diplopia, Ear, nose and throat examination, Glycosylated haemoglobin
Clinical narrative: developed and retained diplopia, with increase intensity after the 2nd shot...its been going on for 14 almost 15 weeks.; developed and retained diplopia, with increase intensity after the 2nd shot...its been going on for 14 almost 15 weeks.; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 28Feb2021 (Batch/Lot Number: EN6205) as dose 2, single for covid-19 immunisation at the age of 42-year-old. The patient medical history and concomitant medications were not reported. The patient previously the first dose of bnt162b2 (lot number EN6201) in the right arm on 07Feb2021 (at 42-year-old) as a single dose for COVID-19 immunisation. The patient was allergic to Bactrim. The patient had not received any other vaccines in the four weeks prior to the COVID vaccine. The patient took unspecified concomitant medications within 2 weeks of the COVID-19 vaccine. On 08Feb2021, the patient developed and retained diplopia, with increase intensity after the 2nd shot and it's been going on for 14 almost 15 weeks. The event resulted in Doctor or other healthcare professional office/clinic visit and was treated. Outcome of the events was not recovered. Lab tests included a computerised tomogram (CAT scan); ear, nose, and throat (ENT) scope, and A1C blood tests, all of which were completed on unknown dates with unknown results. Since vaccination the patient was tested for COVID-19 on 05May2021 via nasal swab which was negative.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021550228 Same patient, same drug with different dose, similar AE.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: developed and retained diplopia, with increase intensity after the 2nd shot...its been going on for 14 almost 15 weeks.; developed and retained diplopia, with increase intensity after the 2nd shot...its been going on for 14 almost 15 weeks.; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 28Feb2021 (Batch/Lot Number: EN6205) as dose 2, single for covid-19 immunisation at the age of 42-year-old. The patient medical history and concomitant medications were not reported. The patient previously the first dose of bnt162b2 (lot number EN6201) in the right arm on 07Feb2021 (at 42-year-old) as a single dose for COVID-19 immunisation. The patient was allergic to Bactrim. The patient had not received any other vaccines in the four weeks prior to the COVID vaccine. The patient took unspecified concomitant medications within 2 weeks of the COVID-19 vaccine. On 08Feb2021, the patient developed and retained diplopia, with increase intensity after the 2nd shot and it's been going on for 14 almost 15 weeks. The event resulted in Doctor or other healthcare professional office/clinic visit and was treated. Outcome of the events was not recovered. Lab tests included a computerised tomogram (CAT scan); ear, nose, and throat (ENT) scope, and A1C blood tests, all of which were completed on unknown dates with unknown results. Since vaccination the patient was tested for COVID-19 on 05May2021 via nasal swab which was negative.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021550228 Same patient, same drug with different dose, similar AE.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Insomnia, Rash
Clinical narrative: I am having rash, the rash started just little bit on my stomach, I can feel it all over my body, it's not coming down; Really hard for me to sleep at night time; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EW0199) via an unspecified route of administration in arm left on 13May2021 as single dose for COVID-19 immunization. Medical history included diabetic. Concomitant medications included metformin hydrochloride, saxagliptin hydrochloride (KOMBIGLYZE) for Diabetes. The patient stated that she took the first dose of vaccine on 13May and on an unspecified date in 2021 she is having rash, the rash started just little bit on her stomach and now she can feel it all over my body, it's not coming down and she said that this is more than a one month now and she is still suffering from this rash she said that it's started just little bit and spreading all over and it's really hard for her to sleep at night time also. The patient underwent lab tests and procedures which included blood test, result was unknown. Patient received Cetirizine Hydrochloride as treatment for events. The seriousness of the events was not serious. The outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: my period became very heavy and painful after I completed my vaccination; my period became very heavy and painful after I completed my vaccination; became less predictable; This is a spontaneous report from a contactable consumer (patient). A 35-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0175), via an unspecified route of administration on 07May2021 (at the age of 31-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination and no known allergy. Patient medical history and concomitant medications were not reported. The patient stated that on unspecified date May2021 my period became very heavy and painful after I completed my vaccination. And overall cycle that has always been regular became less predictable. Since it's only been under 2 months since I completed my second shot. Prior to vaccination, the patient did not diagnose with COVID-19, since the vaccination, the patient not been tested for COVID-19. The patient did not received treatment for the adverse event. The outcome of event unknown.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Breast pain, Breast swelling, Contusion
Clinical narrative: Roughly 20 hours post- second vaccine, the lymph nodes in my left became inflamed; My left underarm, breast, and shoulder became swollen and painful with my underarm developing a discolored bruise; My left underarm, breast, and shoulder became swollen and painful, with my underarm developing a discolored bruise; My left underarm, breast, and shoulder became swollen and painful, with my underarm developing a discolored bruise; My left underarm, breast, and shoulder became swollen and painful, with my underarm developing a discolored bruise; My left underarm, breast, and shoulder became swollen and painful, with my underarm developing a discolored bruise; My left underarm, breast, and shoulder became swollen and painful, with my underarm developing a discolored bruise; underarm developing a discolored bruise; underarm developing a discolored bruise; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 28-year-old non pregnant female patient received BNT162B2 (Solution for injection; Batch/Lot Number: EW0198, Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 10Jul2021 09:15AM as DOSE 2, SINGLE for covid-19 immunization (at the age of 28-year-old). Medical history included asthma and known allergies for penicillin, garlic and sulfur from an unknown date and unknown if ongoing. The patient had not received any other vaccine within 4 weeks and other medication in two weeks. Patient was not pregnant at time of vaccination. The patient had not been diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. There were no concomitant medications. Historical vaccine included patient previously took Pfizer (BNT162B2) dose 1 on 11Jun2021 at 09:00AM in left arm for covid-19 immunization. On 11Jul2021 at 05:00 AM the patient experienced Roughly 20 hours post- second vaccine, the lymph nodes in left became inflamed. The patient left underarm, breast and shoulder became swollen and painful, with underarm developing a discolored bruise. The Patient received no treatment for the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Lymphadenitis, Skin discolouration, Swelling
Clinical narrative: Roughly 20 hours post- second vaccine, the lymph nodes in my left became inflamed; My left underarm, breast, and shoulder became swollen and painful with my underarm developing a discolored bruise; My left underarm, breast, and shoulder became swollen and painful, with my underarm developing a discolored bruise; My left underarm, breast, and shoulder became swollen and painful, with my underarm developing a discolored bruise; My left underarm, breast, and shoulder became swollen and painful, with my underarm developing a discolored bruise; My left underarm, breast, and shoulder became swollen and painful, with my underarm developing a discolored bruise; My left underarm, breast, and shoulder became swollen and painful, with my underarm developing a discolored bruise; underarm developing a discolored bruise; underarm developing a discolored bruise; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 28-year-old non pregnant female patient received BNT162B2 (Solution for injection; Batch/Lot Number: EW0198, Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 10Jul2021 09:15AM as DOSE 2, SINGLE for covid-19 immunization (at the age of 28-year-old). Medical history included asthma and known allergies for penicillin, garlic and sulfur from an unknown date and unknown if ongoing. The patient had not received any other vaccine within 4 weeks and other medication in two weeks. Patient was not pregnant at time of vaccination. The patient had not been diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. There were no concomitant medications. Historical vaccine included patient previously took Pfizer (BNT162B2) dose 1 on 11Jun2021 at 09:00AM in left arm for covid-19 immunization. On 11Jul2021 at 05:00 AM the patient experienced Roughly 20 hours post- second vaccine, the lymph nodes in left became inflamed. The patient left underarm, breast and shoulder became swollen and painful, with underarm developing a discolored bruise. The Patient received no treatment for the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rhinorrhoea
Clinical narrative: Sore arm at injection site; very painful for 2 days; Runny nose for 4 hours; This is a spontaneous report from a contactable pharmacist. A 44-years-old female patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3246) via an unspecified route of administration in Arm Left on 03Mar2021 (age at vaccination:44-Years-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination. The patient medical history and concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On Mar2021 the patient experienced sore arm at injection site; very painful for 2 days, runny nose for 4 hours on Mar2021. The outcome of the events pain in extremity, rhinorrhea was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received Pentacel vaccine at 4 months and 12 months with no AE; Initial information was received on 14-Sep-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a patient (age unspecified) who received DIPHTHERIA/TETANUS/5 HYBRID ACPERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] at 4 months and 12 months (Inappropriate schedule of product administration).  It was unknown if the patient had any medical history, concomitant disease or risk factor  The patient's past vaccination(s) included Vaxelis with at 2 months for prophylactic vaccination.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), HIB VACCINE CONJ (MENIGOCOCCAL PROTEIN), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (VAXELIS) for prophylactic vaccination at 6 months.  On unknown dates, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number not reported, Suspension for injection) via unknown route in unknown administration site for prophylactic vaccination at 4 months and 12 months.  It was a case of an actual medication error due to Inappropriate schedule of product administration   It was reported "This account is utilizing Vaxelis at 2 months and 6 months and using Pentacel at 4 months and 12 months"  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy with no reported adverse event; Initial information received on 15-Sep-2021 regarding an unsolicited valid non-serious case from an other health professional and physician.  This case involves a 28 years old female pregnant patient who was exposed to vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE]. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported event occurred at 30 weeks of gestation period (exposure during pregnancy).  The date of last menstrual period was reported as 14-Feb-2021.  The estimated delivery due date was 08-Nov-2021.  The information on patient's previous pregnancy was unknown.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 15-Sep-2021, the patient received a dose of suspect FLUZONE (lot 4T7325GA and expiration date: 30-Jun-2022) via intramuscular route in an unknown administration site for prophylactic vaccination.  It was a case of vaccine exposure during pregnancy (same day latency).  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were laboratory data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, patient had no adverse event and the outcome was unknown for the reported event.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.
Sex: F
Vaccine: FLU4
Symptoms: Rash, Tachycardia
Clinical narrative: tachycardia; increased respirations by the end of her shift; a rash on her back and chest, rash spread to her face and scalp and went down below; Initial information regarding an unsolicited valid non serious case was received from physician and consumer/non-health care professional via Medical Information (Reference number- 00766524) and transmitted to Sanofi on 13-Sep-2021.  This case involves a 45-year-old female patient who experienced tachycardia, increased respirations by the end of shift (respiration rate increased), and a rash on her back and chest, rash spread to her face and scalp and went down below (rash) after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. Past medical treatment, vaccination and family history were not provided.  The patient's past medical treatment, vaccination and family history were not provided.  Past medical history was reported, the patient had ongoing drug allergy, cosmetic allergy and spice allergy.  Concomitant medications included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) LORATADINE (CLARITIN [LORATADINE]) PARACETAMOL (TYLENOL) allergy prophylaxis.  On 24-Sep-2014, the patient received a total first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [frequency: once, strength: standard, lot UI169AA, expiry date not reported] via an intramuscular route in right deltoid for prophylactic vaccination.  In 2014, the patient developed a non-serious rash on her back and chest, rash spread to her face and scalp and went down below (rash) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On an unknown date the patient developed a non-serious tachycardia, increased respirations by the end of her shift (respiration rate increased) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No other vaccines.  The reporter reported "Caller states that she received the vaccine at the hospital that she worked for and they are now trying to mandate a coronavirus disease (COVID-19) vaccine for all employees. caller is trying to determine if the FLUQUAD ID PF vaccine contained any of the same preservatives as the COVID-19 vaccine so that she may be exempt from receiving it. caller states that she prophylactically took Benadryl, Claritin, and Tylenol prior to the FLUQUAD ID PF vaccine because of her allergy history."   Other laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the events.  On unknown date, patient was recovered for all events.
Sex: F
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: Infs split virus; Initial information received on 13-Sep-2021 regarding an unsolicited valid  non-serious case received from a consumer or non- healthcare professional (hcp).  This case involves female patient (age not reported) who experienced infs (influenza) split virus when received vaccine INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On 30-Nov-2010, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE (lot number: UH214AB and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On 30-NOV-2010 the patient developed a non-serious infs (influenza) split virus (influenza) same day following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the event [Infs (influenza) split virus].  The event outcome was unknown for influenza.; Sender's Comments:  00766451:
Age: 6.0
Sex: M
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a patient received IPOL vaccine third dose on 6 year of age and fourth dose on 16 years of age/ No AE; Initial information received on 14-Sep-2021 regarding an unsolicited valid non-serious case received from an other health care professional via consumer via Medical Information number: 00767893 via phone.  This case involves a six-year-old male patient who received a third dose of IPV (VERO) [IPOL] and fourth dose of the same vaccine at 16 years of age (inappropriate schedule of product administration).  The patient's past vaccinations included first dose of IPOL [POLIO VACCINE INACT 3V (VERO)] in Jul-2005 at three month of age and second dose of the same vaccine in Sep-2005 at five month of age for prophylactic vaccination respectively.  The patient's medical history, past medical treatments and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and MENINGOCOCCAL VACCINE B [Meningitis B vaccine] for prophylactic vaccination respectively.  On an unknown date in January 2011, the patient received a third dose of suspect IPV (VERO) lot number and expiry date not reported via an unknown route in unknown administration site for prophylactic vaccination.  On 17-Aug-2021, the patient received a 0.5 ml fourth dose of suspect IPV (VERO) lot number: R1F972M, expiry date not reported, strength: standard, frequency: once via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate schedule of vaccine administered (latency same day).   It was reported "Caller states that a patient has already received a full series of IPOL vaccinations and that the practice accidentally began a second series starting on 17-Aug-2021. Caller states that the patient is scheduled to come in for their second dose of their second series of IPOL and wanted to know if there was any risk in this and how to proceed. Caller states that the patient previously received IPOL in July and September of 2005 at ages 3 and 5 months as well as in January of 2011 at age 6 years and most recently on 17-Aug-2021 at age 16 years. Caller asked about safety of the vaccine. Fifth dose was scheduled."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   There will be no information on the lot number of the third dose of vaccine in this case.
Age: 0.17
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: influenza vaccine expired in June was administered to a baby with no reported adverse event; Initial information received on 14-Sep-2021 regarding an unsolicited valid non-serious case from physician and consumer/ non healthcare professional via Media Information (under reference 00767922).  This case involves a 9 months old male patient who received an expired dose of QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 13-Sep-2021, the patient received a 0.5 mL dose of suspect FLUZONE QIV (total, lot UT700BA and expiration date: 30-Jun-2021) via intramuscular route in the right thigh for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported "HCP (health care professional) states influenza vaccine expired in June was administered to a baby and would like recommendations on what to do."  At time of reporting, no adverse event was reported and the outcome was unknown for the reported event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.