chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: lack of effect with Botox Cosmetic; COVID; This is a spontaneous report received from other healthcare professional in response to the mail. This other-HCP reported similar events for 5 female patients have all experienced lack of effect with Botox Cosmetic, and they have never seen that before. This case is for the patient 2.  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation and botulinum toxin type a (BOTOX, Batch/Lot Number: C6700C3; Expiration Date: Oct2023) via an unspecified route of administration on an unspecified date at an unspecified dose and frequency for an unspecified indication. Medical history included covid-19 positive. The patient's concomitant medications were not reported. Reporter was requesting replacement of the vials that were used for those patients. She states Botox cosmetic is not working for 5 patients with the "last three 100 unit vials that we've ordered from you guys". Positive COVID diagnosis is on record and patient got the first dose of her vaccination (possibly Pfizer, but HCP office unsure), and didn't get the second dose due to patient getting COVID. Reporter also wants to order Botox Cosmetic, since "all (she) has left is the vial with some in it" and said she will request Medical Information transfer her to Botox Customer Service after they resolve her inquiry. The patient was not hospitalized or was hospitalization prolonged as a result of the AE. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.; Sender's Comments: Based on the known safety profile and limited information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Covid-19.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate increased, Hypertension, Hypoaesthesia, Pruritus
Clinical narrative: Blood pressure went up to 170 /100; Numbing of my neck and left side of my face to my nose; Increased pulse rate; back and head itching; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm left on 29Mar2021 09:15 (Batch/Lot number: ER8734) (at the age of 64-year-old) as 1st dose, single for COVID-19 immunisation. Medical history included allergies to dairy, cats, sulfa drugs, seasonal allergies and blood pressure. The patient was on unspecified medication (received within 2 weeks of vaccination) to control blood pressure. 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 29Mar2021 09:30, within 15 minutes of injection, the patient had numbing of neck and left side of my face to my nose and blood pressure went up to 170 /100. 12 hours later back and head itching, afterwards but now it seems to be calm down and had increased pulse rate. Due to events patient visited doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with Benadryl. The outcome of the event increased pulse rate was unknown, and all other events was recovered on an unknown date in 2021.  Follow-up attempts are needed. Further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bedridden, Gait inability, Paraesthesia, Vaccination site pain, Vomiting
Clinical narrative: Vomiting; Paraesthesia foot; Bed ridden; Unable to walk; Vaccination site pain; This is a spontaneous report from a contactable physician.    A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular on 26Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for rheumatoid arthritis.The patient medical history was not reported. The patient's concomitant medications were not reported. On 29Mar2021, patient experienced unable to walk with outcome of recovering , vaccination site pain with outcome of recovering , vomiting on 30Mar2021 with outcome of unknown , paraesthesia foot  on 29Mar2021 with outcome of recovering , bed ridden on 29Mar2021 with outcome of unknown.  The action taken in response to the event(s) for bnt162b2 was not applicable , for adalimumab was unknown.  No follow up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Eye disorder, Musculoskeletal disorder
Clinical narrative: Upper extremity dysfunction; Eye disorder; This is a spontaneous report from a non-contactable consumer based on the information received by Pfizer.   A elderly female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, for rheumatoid arthritis. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced upper extremity dysfunction on an unspecified date with outcome of not recovered , eye disorder on an unspecified date with outcome of not recovered.  The action taken in response to the event(s) for bnt162b2 was not applicable , for adalimumab was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthenia, Fatigue
Clinical narrative: WEAKNESS; Fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 40 mg for rheumatoid arthritis. The patient medical history was not reported. Concomitant medication(s) included lisinopril; sildenafil citrate (ELEVE); cyanocobalamin/folic acid. On Mar2021, patient experienced weakness with outcome of unknown , fatigue with outcome of not recovered.  The action taken in response to the event(s) for bnt162b2 was not applicable , for adalimumab was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Psoriasis, Rash papular, Urticaria
Clinical narrative: severe psoriasis; Large and small red welts and bumps; Large and small red welts and bumps; It is incredibly itchy; This is a spontaneous report received from a contactable consumer (patient). This 61-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 left arm on 24Mar2021 at 18:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis, and penicillin early generation allergy, both from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. The patient had no allergies to foods. Concomitant medications included prednisone 5 mg from an unknown date for an unknown indication. Prior to vaccination the patient received azathioprine from an unknown date for an unknown indication and experienced drug allergy; infliximab (REMICADE) from an unknown date for an unknown indication and experienced psoriasis; adalimumab (HUMIRA) from an unknown date for an unknown indication and experienced psoriasis; and received the first dose of BNT162B2 (lot number unknown) on 24Feb2021 at 18:15 (at the age of 60-years-old) for COVID-19 immunisation. The patient had not received any other vaccines in the four weeks prior to the COVID vaccine. The patient reported that on 04Apr2021 he developed severe psoriasis within three weeks of the vaccine; further stating he developed similar reactions to infliximab and adalimumab and generally had received methotrexate to control the reaction. He reported large and small red welts and bumps on his arms, torso and hands, as well as to a lesser extent his face, scalp, buttocks, legs and feet. He reported it was incredibly itchy, similar to poison ivy or bad psoriasis. He reported not having these symptoms prior to the vaccine, that there had been no intervening medicines, and that he had no food allergies. The clinical outcomes of severe psoriasis, large and small red welts and bumps, and it was incredibly itchy were not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Vomiting
Clinical narrative: Medical history and concomitant medications were not reported. The reporter stated that her mom got her COVID shot yesterday and did not feel too well. The patient was throwing up and had a bad headache. The reporter inquired what the patient could take. The clinical outcomes of did not feel too well, throwing up and had a bad headache were unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: The patient didn't have any medical conditions or medications that she is taking. It was reported that I am experiencing chest pains, is this normal? When I breath in it hurts in the left side of my chest. The event started on an Apr2021 with outcome of unknown. The event was reported as non-serious.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Swelling
Clinical narrative: Swelling observed on the neck on the same side as the vaccinated arm; Swollen in my neck like lymph node; I feel tight; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER COVID 19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 15:30 (Lot number: ER8733) as single dose for covid-19 immunisation at the age of 48-year-old. The patient was not pregnant at vaccination. There were no medical history and concomitant medication. No allergy to medications, food, or other products. The patient was not diagnosed with COVID 19 prior to vaccination and hasn't been tested for COVID 19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling observed on the neck on the same side as the vaccinated arm on 17Apr2021 with outcome of not recovered and no treatment received for the event. The event was reported as non-serious. It was further reported as "I had a vaccine on 06Apr, so now I felt in the left hand that, swollen in my neck like lymph node. Is it related to the vaccine because I feel tight?". The event "I feel tight" was stated in Apr2021 with outcome of unknown. The event swollen in my neck like lymph node was started on 17Apr2021 with outcome of not recovered and no treatment received for the event.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Investigation, Nasopharyngitis, Polymerase chain reaction
Clinical narrative: cold symptoms; I started feeling bad on Monday; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported as "I am due to my get second dose today and I currently am experiencing cold symptoms. I started feeling bad on Monday and got a rapid and a PCR test and both were negative. I feel much better than I did." The events started on 2021 with outcome of recovering. The patient underwent lab tests and procedures which included investigation: a rapid and a PCR test and both were negative in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: really achy/flu-like aches; a really bad headache; joint soreness; am still nauseous; I had the chills; sweats; extreme fatigue; This is a spontaneous report from a contactable consumer (patient). This 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation and experienced extreme fatigue and headache. The patient reported experiencing really achy flu-like aches, a really bad headache, and joint soreness, described as painful to walk down the steps, for the first 36 hours. The patient further reported still feeling nauseous, stating she got "it" on Friday afternoon; she had chills and "now" she had the sweats and fatigue, further described as extreme fatigue that she fell asleep at her son's baseball game. She stated she was "never ever" warm and she was sweating "right now." The clinical outcomes of nauseous, sweats and extreme fatigue were not recovered; the outcomes of really achy/flu-like aches, headache, joint soreness, and chills were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: really achy/flu-like aches; a really bad headache; joint soreness; am still nauseous; I had the chills; sweats; extreme fatigue; This is a spontaneous report from a contactable consumer (patient). This 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation and experienced extreme fatigue and headache. The patient reported experiencing really achy flu-like aches, a really bad headache, and joint soreness, described as painful to walk down the steps, for the first 36 hours. The patient further reported still feeling nauseous, stating she got "it" on Friday afternoon; she had chills and "now" she had the sweats and fatigue, further described as extreme fatigue that she fell asleep at her son's baseball game. She stated she was "never ever" warm and she was sweating "right now." The clinical outcomes of nauseous, sweats and extreme fatigue were not recovered; the outcomes of really achy/flu-like aches, headache, joint soreness, and chills were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Constipation
Clinical narrative: Constipation; This is a spontaneous report from a non-contactable consumer (patient). This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 18Apr2021, reported as "today" between 10:15 and 10:30, as a single dose for COVID-19 immunisation. Medical history included handicap, broken hip and cane use, all from unknown dates and unknown if ongoing. Concomitant medications were not reported. The patient reported receiving the first dose of BNT162B2 "today" (as of 18Apr2021) between 10:15 and 10:30. She called to inquire if constipation could be a side effect of the vaccine, further reporting she usually had a bowel movement after lunch. She reported her doctor told her if she didn't have a bowel movement she could have some "BENEFIBER." The event was reported as non-serious. The clinical outcome of constipation was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Hypersensitivity, Nasal congestion
Clinical narrative: The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included fexofenadine (ALLEGRA) and rabeprazole from unknown dates for unknown indications. On 17Apr2021, 24 hours after the vaccine, the patient experienced shaking and chills. She was feeling fatigued. The patient slept for 3 hours, woke up around 20:00 on 17Apr2021, and had severe allergy attack all night even though allergy medications were taken. No medications were working. She had symptoms such as severe nasal congestion, sinus pressure, difficulty breathing after using inhaler, burning throat and nasal passages, shortness of breath. It was the worst allergy attack she had ever had. It felt like her immune system shut down and was reacting to everything she was allergic to on a large scale. The patient reported she did not receive any treatment for the events. The outcomes of shaking, chills, severe nasal congestion, sinus pressure, difficulty breathing, burning throat and nasal passages, and shortness of breath were not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal discomfort, Paranasal sinus discomfort, Throat irritation, Tremor
Clinical narrative: The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included fexofenadine (ALLEGRA) and rabeprazole from unknown dates for unknown indications. On 17Apr2021, 24 hours after the vaccine, the patient experienced shaking and chills. She was feeling fatigued. The patient slept for 3 hours, woke up around 20:00 on 17Apr2021, and had severe allergy attack all night even though allergy medications were taken. No medications were working. She had symptoms such as severe nasal congestion, sinus pressure, difficulty breathing after using inhaler, burning throat and nasal passages, shortness of breath. It was the worst allergy attack she had ever had. It felt like her immune system shut down and was reacting to everything she was allergic to on a large scale. The patient reported she did not receive any treatment for the events. The outcomes of shaking, chills, severe nasal congestion, sinus pressure, difficulty breathing, burning throat and nasal passages, and shortness of breath were not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Mood altered, Pain
Clinical narrative: Really bad headache; "moody aches"; "moody aches"; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0170) via an unspecified route of administration on 17Apr2021 at 14:30 (at the age of 58-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. the patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included amlodipine from an unknown date for an unknown indication. On 17Apr2021 the patient experienced a really bad headache and "moody aches" the first 24 hours after injection. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of headache and "moody aches" were recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8727; expiration date: 31Jul2021) via an unspecified route of administration on 15Apr2021 as a single dose for COVID-19 immunization. Medical history included irritable bowel syndrome (IBS), heart problem, and "allergies (the sinusitis)." Concomitant medications included atenolol from an unknown date for tachycardia, heart problem. Today (18Apr2021) the patient experienced a mild headache. She had the first dose and was fine there while she sat for 15 or 20 minutes. She was normal that day. Today (18Apr2021) she had a mild headache but she also had allergies and yesterday (17Apr2021) she drank a little bit of wine to keep her nerves because it was getting crazy, "this new variant and everything." The patient asked if it was okay to take paracetamol (TYLENOL), aspirin, or ibuprofen (ADVIL). The outcome of mild headache was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Contusion, Headache, Magnetic resonance imaging
Clinical narrative: headaches; rashes; bruising; nerve damage; skin sensitivity; This is a spontaneous report from a contactable consumer (patient). An unspecified age and gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810 Expiry date: 04Mar2021), dose 1 via an unspecified route of administration on 11Feb2021, as single for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. It was reported that patient received Pfizer Covid vaccine on 11Feb2021. Since then, the patient had terrible headaches, rashes, bruising, and skin sensitivity which the doctors believe to be nerve damage. It resulted in multiple hospital trips in February, and close to a dozen doctors visits since then. Patient has taken multiple tests to determine exactly what going on, including blood tests, CT scans, and an MRI.As you might imagine, this has resulted in extremely expensive medical bills. The patient suffered everyday from side effects which the patient did not even know could happen from a vaccine. The patient was hoping it would go away on its own, but this had been going on nearly 3 months at this point and did not show signs of stopping any time soon. The patient thought was doing the right thing by getting the COVID vaccine, but would never take another one again. The patient underwent multiple tests as mentioned above and has resulted in extremely expensive medical bills. over 2 months later. This has resulted in medical bills that would keep the patient in debt for years, as well as pain that affected every day. The patient needed financial assistance to pay for these medical bills and for the doctors appointments and tests that would come up. The patient underwent lab tests and procedures which included blood tests, CT scans, and an MRI on unspecified date. The outcome of events was not recovered.  Follow-up (10May2021): This is a follow up-spontaneous report from a contactable consumer. New information included: The events and clinical information was added.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nerve injury, Rash, Sensitive skin
Clinical narrative: headaches; rashes; bruising; nerve damage; skin sensitivity; This is a spontaneous report from a contactable consumer (patient). An unspecified age and gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810 Expiry date: 04Mar2021), dose 1 via an unspecified route of administration on 11Feb2021, as single for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. It was reported that patient received Pfizer Covid vaccine on 11Feb2021. Since then, the patient had terrible headaches, rashes, bruising, and skin sensitivity which the doctors believe to be nerve damage. It resulted in multiple hospital trips in February, and close to a dozen doctors visits since then. Patient has taken multiple tests to determine exactly what going on, including blood tests, CT scans, and an MRI.As you might imagine, this has resulted in extremely expensive medical bills. The patient suffered everyday from side effects which the patient did not even know could happen from a vaccine. The patient was hoping it would go away on its own, but this had been going on nearly 3 months at this point and did not show signs of stopping any time soon. The patient thought was doing the right thing by getting the COVID vaccine, but would never take another one again. The patient underwent multiple tests as mentioned above and has resulted in extremely expensive medical bills. over 2 months later. This has resulted in medical bills that would keep the patient in debt for years, as well as pain that affected every day. The patient needed financial assistance to pay for these medical bills and for the doctors appointments and tests that would come up. The patient underwent lab tests and procedures which included blood tests, CT scans, and an MRI on unspecified date. The outcome of events was not recovered.  Follow-up (10May2021): This is a follow up-spontaneous report from a contactable consumer. New information included: The events and clinical information was added.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Skin sensitisation
Clinical narrative: headaches; rashes; bruising; nerve damage; skin sensitivity; This is a spontaneous report from a contactable consumer (patient). An unspecified age and gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810 Expiry date: 04Mar2021), dose 1 via an unspecified route of administration on 11Feb2021, as single for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. It was reported that patient received Pfizer Covid vaccine on 11Feb2021. Since then, the patient had terrible headaches, rashes, bruising, and skin sensitivity which the doctors believe to be nerve damage. It resulted in multiple hospital trips in February, and close to a dozen doctors visits since then. Patient has taken multiple tests to determine exactly what going on, including blood tests, CT scans, and an MRI.As you might imagine, this has resulted in extremely expensive medical bills. The patient suffered everyday from side effects which the patient did not even know could happen from a vaccine. The patient was hoping it would go away on its own, but this had been going on nearly 3 months at this point and did not show signs of stopping any time soon. The patient thought was doing the right thing by getting the COVID vaccine, but would never take another one again. The patient underwent multiple tests as mentioned above and has resulted in extremely expensive medical bills. over 2 months later. This has resulted in medical bills that would keep the patient in debt for years, as well as pain that affected every day. The patient needed financial assistance to pay for these medical bills and for the doctors appointments and tests that would come up. The patient underwent lab tests and procedures which included blood tests, CT scans, and an MRI on unspecified date. The outcome of events was not recovered.  Follow-up (10May2021): This is a follow up-spontaneous report from a contactable consumer. New information included: The events and clinical information was added.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy skin abnormal, Headache, Pain, Small fibre neuropathy
Clinical narrative: headaches; rashes; bruising; nerve damage; skin sensitivity; This is a spontaneous report from a contactable consumer (patient). An unspecified age and gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810 Expiry date: 04Mar2021), dose 1 via an unspecified route of administration on 11Feb2021, as single for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. It was reported that patient received Pfizer Covid vaccine on 11Feb2021. Since then, the patient had terrible headaches, rashes, bruising, and skin sensitivity which the doctors believe to be nerve damage. It resulted in multiple hospital trips in February, and close to a dozen doctors visits since then. Patient has taken multiple tests to determine exactly what going on, including blood tests, CT scans, and an MRI.As you might imagine, this has resulted in extremely expensive medical bills. The patient suffered everyday from side effects which the patient did not even know could happen from a vaccine. The patient was hoping it would go away on its own, but this had been going on nearly 3 months at this point and did not show signs of stopping any time soon. The patient thought was doing the right thing by getting the COVID vaccine, but would never take another one again. The patient underwent multiple tests as mentioned above and has resulted in extremely expensive medical bills. over 2 months later. This has resulted in medical bills that would keep the patient in debt for years, as well as pain that affected every day. The patient needed financial assistance to pay for these medical bills and for the doctors appointments and tests that would come up. The patient underwent lab tests and procedures which included blood tests, CT scans, and an MRI on unspecified date. The outcome of events was not recovered.  Follow-up (10May2021): This is a follow up-spontaneous report from a contactable consumer. New information included: The events and clinical information was added.  Information about lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID/ Got COVID after being vaccinated; tested positive for COVID/ Got COVID after being vaccinated; This is a spontaneous report from a contactable nurse and consumer. A 59-year-old female patient (unknown if pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 15Jan2021 12:30 (Lot: EL3248; Expiry: Apr2021) as 1 st dose, single then on 05Feb2021 14:15 (Lot: EL3248; Expiry: Apr2021) as 2 nd dose, single; both intramuscular in left arm (at the age of 59-years-old) for covid-19 immunisation. The vaccination facility type was workplace clinic and not administered at a military facility. It was unknown if pregnant at the time of vaccination. No additional vaccines administered on same date of bnt162b2. The patient did not have covid and was not diagnosed prior vaccination. The other vaccine in four weeks was unknown. The patient had no medical history, no family history and no concomitant medications. Since vaccination, the patient got tested on the 23Apr2021 for COVID-19 and got results back tested positive for COVID on 24Apr2021 PCR Nasal Swab with no treatment. The patient got COVID after being vaccinated. The patient got COVID after getting both vaccines. The patient started getting symptoms on Wednesday evening (on 21Apr2021). That evening she experienced a head cold, she was stuffy, headache, runny nose, and sore throat. The nurse considered the event as non-serious as did not resulted in death, non-life threatening, did not cause/prolong hospitalization, not disabling/incapacitating and no congenital anomaly/birth defect. The patient wanted to call to let Pfizer know that even though she was vaccinated she did contract COVID. She had it now. The event did not require emergency room nor physician office visit. The patient thought the vaccine helped her. Her husband had COVID and she got it from him, but he didn't get vaccinated. The husband's case was a lot worse than hers and she thinks it has helped her not have a bad case. The patient was in no way blaming Pfizer, she just wanted to say that it made it less of a bad case. The outcome of the events was recovering.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Vaccination Failure, COVID-19 and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Pyrexia, Thrombosis
Clinical narrative: may have blood clots; since she took the first COVID vaccine, she did have some symptoms. Her face flushed, like she had a temperature and experienced fatigue; since she took the first COVID vaccine, she did have some symptoms. Her face flushed, like she had a temperature and experienced fatigue; since she took the first COVID vaccine, she did have some symptoms. Her face flushed, like she had a temperature and experienced fatigue; This is a spontaneous report from a contactable consumer received from a non-Pfizer sponsored program,, received from a contactable consumer, based on information received by Pfizer. This case is split for a 80 year old patient taking COVID vaccine and experienced face flushed, fatigue.  This 80-year-old female patient received first dose of (PFIZER BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: unknown), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. Medical history included high frequency ablation (vein), breast cancer from 2015 to an unknown date (34 radiation treatment to left breast and no recurrence of the cancer), radiotherapy (breast cancer), atrial fibrillation from Jan2016 to an unknown date, surgery (she had 6 veins removed from her legs). Concomitant medication(s) included apixaban (ELIQUIS) taken for cerebrovascular accident prophylaxis (batch no. 1745824) (oral, 5 milligram, twice a day) in 2017 or 2018, losartan taken for blood pressure (50 mg once daily), paracetamol (TYLENOL) taken for pain (as needed (but not every day)), vitamin b nos, ascorbic acid, zinc, colecalciferol and cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]). The patient experienced since she took the first COVID vaccine, she did have some symptoms, her face flushed, like she had a temperature and experienced fatigue, and may have blood clots. The patient reported that she may have blood clots but was unsure because she did not underwent any tests to confirm. The patient was due for her second COVID-19 vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Overdose, Product preparation error
Clinical narrative: patient who received an undiluted dose of the Pfizer Covid vaccine; patient who received an undiluted dose of the Pfizer Covid vaccine; Light-headed; This is a spontaneous report from a contactable pharmacist. A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Formulation: Solution for injection, Batch/Lot Number: ER8727; Expiration Date: Jul2021), Via an unspecified route of administration, administered on 26Apr2021 09:30 as single dose for COVID-19 immunization. NDC number of Pfizer Covid vaccine was 59267-1000-01. The patient medical history and concomitant medications were not reported. on 26Apr2021, The reporter was a clinical pharmacist coordinator for a hospital system in Mississippi. Was notified by one of the clinics administering the Covid vaccine that a patient had got the vaccine without it being diluted. They had gotten 0.3ml undiluted vaccine from the vial (undiluted dose of the pfizer covid vaccine) and the patient was little lightheaded from 26Apr2021. The outcome of events was unknown.  Follow-up (28Apr2021): New information received from the mail trail sent includes: Patient is 69 years old, (ethnicity withheld) female, DOB: (withheld) Amendment: This follow up is being submitted to amend previously reported information: The event recoded to patient who received an undiluted dose of the Pfizer Covid vaccine to Product concentrate not diluted and overdose and to delete the event wrong diluent used.  No follow-up attempts are possible; No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Impaired work ability
Clinical narrative: unable to work since vaccinated; severe allergy reaction; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Mar2021 (Batch/Lot number was not reported) at 1st dose, single for covid-19 immunisation. Medical history included COVID in Jan2021. The patient's concomitant medications were not reported. On 18Mar2021, the patient experienced severe allergy reaction since first dose of Pfizer vaccine. Unable to take 2nd dose advised. The patient continued to have severe medical problems which her medical doctors were unclear. She felt like she was poisoned on top of underline ailments since 911 and going through 912 since vaccine. Patient stated that she needs medical advice, unable to work since vaccinated, worse than the covid she had in Jan2021. The patient stated "Help, feel like I'm dying slowly". Outcome of the events was unknown  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: very sleepy; This is a spontaneous report from a non-contactable consumer (the patient's husband) from a Pfizer-sponsored program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date in Apr2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose 2-3 days ago, and she was very sleepy (Apr2021). The outcome of the event was unknown.    No follow-up attempts are possible; information about batch/Lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got Covid; got Covid; This is a spontaneous follow-up report received from Pfizer sponsored Program via a contactable nurse (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration, first single dose and second single dose on an unspecified date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she got Covid for the SECOND time after she received both Pfizer vaccines. She was a nurse but wear Personal Protective Equipment (PPE) all the time. The outcome of the event was unknown.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a non-contactable consumer via a Pfizer sales representative. A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a headache after the second dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report from a Pfizer sponsored program, received report from a contactable male consumer (patient).A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 05Apr2021 (Batch/Lot number: EW0150) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified patient was sick. The patient stated he did not take the 2nd dose of the Covid-19 vaccine which was on last 26Apr2021 because he was sick then and he wanted to reschedule his 2nd dose appointment. The outcome of event was Unknown.  There were no unaddressed medical questions referred or forwarded to Medical Information.  Follow up (28Apr2021):New information was received from consumer included: additional lot number added.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Neuropathy peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Neuropathy; her left foot now has the same stinging, burning, pain that the right toe; swelling has decreased in the right foot; but continues in the left; her left foot now has the same stinging, burning, pain that the right toe/her left foot now has the same stinging, burning, pain that the right toe; her right foot was numb and tingling; her right foot was numb and tingling; Right foot turning purple intermittently; This is a spontaneous report from a contactable consumer. A 22-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 16Apr2021 (Batch/Lot Number: ER8731) as 2nd dose, single for covid-19 immunisation. Medical history included Hashimoto's thyroiditis, premature ovarian failure and covid-19. Concomitant medications were not reported. After the second shot the patient received in Apr2021, she was sitting for the 15 minutes after the vaccine and her right foot was numb and tingling. Her left foot was fine. At home after the vaccine the patient had her feet propped up and her toes were purple.  They did not think about it being any type of side effect from the Covid Vaccine; they thought maybe her foot was wrapped too tightly. On Monday, 26Apr2021, her big toe on her left foot now has the same stinging, burning, pain that the right toe had in it when this all began. Her toes on both feet are still turning purple off and on.  The doctor says that since when they are pressed the purple goes away then comes back it is okay. Both feet were swollen at one time.  The swelling has decreased in the right foot; but continues in the left. It was believed that the patient was suffering from neuropathy. The patient was recovering from the event peripheral swelling. The outcome of the events was pain in extremity and skin coloring was not recovered. The outcome of other events was unknown.   Information about lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Skin discolouration
Clinical narrative: Neuropathy; her left foot now has the same stinging, burning, pain that the right toe; swelling has decreased in the right foot; but continues in the left; her left foot now has the same stinging, burning, pain that the right toe/her left foot now has the same stinging, burning, pain that the right toe; her right foot was numb and tingling; her right foot was numb and tingling; Right foot turning purple intermittently; This is a spontaneous report from a contactable consumer. A 22-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 16Apr2021 (Batch/Lot Number: ER8731) as 2nd dose, single for covid-19 immunisation. Medical history included Hashimoto's thyroiditis, premature ovarian failure and covid-19. Concomitant medications were not reported. After the second shot the patient received in Apr2021, she was sitting for the 15 minutes after the vaccine and her right foot was numb and tingling. Her left foot was fine. At home after the vaccine the patient had her feet propped up and her toes were purple.  They did not think about it being any type of side effect from the Covid Vaccine; they thought maybe her foot was wrapped too tightly. On Monday, 26Apr2021, her big toe on her left foot now has the same stinging, burning, pain that the right toe had in it when this all began. Her toes on both feet are still turning purple off and on.  The doctor says that since when they are pressed the purple goes away then comes back it is okay. Both feet were swollen at one time.  The swelling has decreased in the right foot; but continues in the left. It was believed that the patient was suffering from neuropathy. The patient was recovering from the event peripheral swelling. The outcome of the events was pain in extremity and skin coloring was not recovered. The outcome of other events was unknown.   Information about lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Dyspnoea, Lymphadenopathy, Mammogram, Ultrasound scan
Clinical narrative: Persistent swollen lymph glands in left armpit. Extreme shortness of breath.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Laboratory test, Pregnancy
Clinical narrative: Miscarried on may 13, 2021, exactly 3 weeks later.  I was 6 weeks at the time of miscarriage.  I have one healthy child and no history of miscarriage.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: coughed; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer Sponsored Program. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. During the call, the patient coughed and stated he/she didn't have Covid because he/she got the Pfizer vaccine. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.