chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Bone scan, Illness, Osteoporosis, Vaccination complication
Clinical narrative: Vaccination related malaise; Very Sick After Covid-19 Vaccine; Osteoporosis; This is a Spontaneous report based on information received by Pfizer from AbbVie (Manufacturer Control Number#: 21K-163-4102232-00).   A 62-years-old female patient received BNT162B2 (Pfizer/BioNTech solution for injection), dose 3 intramuscular on 24Sep2021 (Batch/Lot number was not reported) as DOSE 3, SINGLE for covid-19 immunization(Age at vaccination 62 years); adalimumab (HUMIRA), subcutaneous from Feb2021 (Batch/Lot number was not reported) to Feb2021, at DOSE NUMBER UNKNOWN, SINGLE for colitis ulcerative. The patient past medical history included Non-smoker user, Alcohol Use/Socially from an unknown date and unknown if ongoing and Colitis ulcerative from an unknown date and unknown if ongoing. Concomitant medication(s) included mesalamine (MESALAMINE) taken for colitis ulcerative, start and stop date were not reported; vitamin D (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported and calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported. On 03Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 03Apr2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. on an unspecified date in Sep2021, the patient experienced Possible Osteoporosis. On 24Sep2021, the patient experienced Very Sick After Covid-19 Vaccine and Vaccination related malaise. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient underwent lab tests and procedures which included bone scan: 2.6 no unit on Sep2021 Normal value: >2.5. The event outcome was not recovered for Osteoporosis and recovered for Vaccination related malaise and Very Sick on 26Sep2021.  Causality for HUMIRA 40MG/0.4ML (ADALIMUMAB) The reporter's causality for the event(s) of Possible Osteoporosis and Very Sick After Covid-19 Vaccine with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Off label use, Product use issue
Clinical narrative: headache observed; Other vaccine same date vaccine date 30Sep2021; Dose received: 3; Booster; This is a spontaneous report from a contactable consumer.  A 79-year-old female patient received third dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot number was not reported ), dose 3 via an unspecified route of administration on 30Sep2021 as dose 3 (booster), single (at the age of 79-year-old ) for COVID-19 immunization and influenza vaccine (FLU VACCINE VII), via an unspecified route of administration from 30Sep2021 (Batch/Lot number was not reported) to 30Sep2021, at dose number unknown, single for immunization. Facility type Vaccine was Pharmacy or Drug Store. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have covid prior vaccination and no covid tested post vaccination. Historical vaccine included bnt162b2 second dose (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot number was not reported), dose 2 via an unspecified route of administration on unspecified date ad dose 2 single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot number was not reported), dose 1 via an unspecified route of administration on unspecified date dose 1 single for COVID-19 immunization. On 30sep2021 the patient received other vaccine same date vaccine date, dose received: 3, booster. On Oct2021, headache observed. No treatment was received for the event headache. The outcome of the event headache was recovered.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Extra dose administered, Fatigue, Headache
Clinical narrative: vomiting; nausea; chills; body aches; large swollen lymph node in arm pit; swelling and pain in neck and shoulder; swelling and pain in neck and shoulder; swelling and pain in neck and shoulder; swelling and pain in neck and shoulder; fever; headache; extreme fatigue; dose_number=3; dose_number=3; This is a spontaneous report from a contactable Other HCP (patient). A 32-year-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: Not Reported, Expiry Date: Not Reported), via unspecified route, administered in Left Arm on 28Sep2021 (at the age of 32-year-old) at 16:45 as dose 3 (booster), single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The medical history included allergy to arthropod sting (bees). The patient concomitant medication included oral contraceptive nos (ORAL CONTRACEPTIVE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported. The patient previously took first and second dose of bnt162b2 via unspecified route, administered in Left Arm on an unspecified date (both at the age of 32-year-old) as dose 1, single and dose 2, single respectively both doses for covid-19 immunisation. The patient previously also took pertussis vaccine for pertussis and experienced drug hypersensitivity and cipro [ciprofloxacin] and experienced drug hypersensitivity. The patient was allergic to cipro and pertussis vaccine, and bees. No covid prior vaccination. No covid tested post vaccination. On 29Sep2021 at 14:00 (24 hours post vaccination), the patient experienced vomiting, nausea, chills, body aches, large swollen lymph node in arm pit, swelling and pain in neck and shoulder, fever, headache, extreme fatigue. The patient did not receive any treatment for the reported event. Outcome of the events was recovered with sequelae.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Neck pain, Off label use, Pain
Clinical narrative: vomiting; nausea; chills; body aches; large swollen lymph node in arm pit; swelling and pain in neck and shoulder; swelling and pain in neck and shoulder; swelling and pain in neck and shoulder; swelling and pain in neck and shoulder; fever; headache; extreme fatigue; dose_number=3; dose_number=3; This is a spontaneous report from a contactable Other HCP (patient). A 32-year-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: Not Reported, Expiry Date: Not Reported), via unspecified route, administered in Left Arm on 28Sep2021 (at the age of 32-year-old) at 16:45 as dose 3 (booster), single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The medical history included allergy to arthropod sting (bees). The patient concomitant medication included oral contraceptive nos (ORAL CONTRACEPTIVE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported. The patient previously took first and second dose of bnt162b2 via unspecified route, administered in Left Arm on an unspecified date (both at the age of 32-year-old) as dose 1, single and dose 2, single respectively both doses for covid-19 immunisation. The patient previously also took pertussis vaccine for pertussis and experienced drug hypersensitivity and cipro [ciprofloxacin] and experienced drug hypersensitivity. The patient was allergic to cipro and pertussis vaccine, and bees. No covid prior vaccination. No covid tested post vaccination. On 29Sep2021 at 14:00 (24 hours post vaccination), the patient experienced vomiting, nausea, chills, body aches, large swollen lymph node in arm pit, swelling and pain in neck and shoulder, fever, headache, extreme fatigue. The patient did not receive any treatment for the reported event. Outcome of the events was recovered with sequelae.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling, Vomiting
Clinical narrative: vomiting; nausea; chills; body aches; large swollen lymph node in arm pit; swelling and pain in neck and shoulder; swelling and pain in neck and shoulder; swelling and pain in neck and shoulder; swelling and pain in neck and shoulder; fever; headache; extreme fatigue; dose_number=3; dose_number=3; This is a spontaneous report from a contactable Other HCP (patient). A 32-year-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: Not Reported, Expiry Date: Not Reported), via unspecified route, administered in Left Arm on 28Sep2021 (at the age of 32-year-old) at 16:45 as dose 3 (booster), single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The medical history included allergy to arthropod sting (bees). The patient concomitant medication included oral contraceptive nos (ORAL CONTRACEPTIVE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported. The patient previously took first and second dose of bnt162b2 via unspecified route, administered in Left Arm on an unspecified date (both at the age of 32-year-old) as dose 1, single and dose 2, single respectively both doses for covid-19 immunisation. The patient previously also took pertussis vaccine for pertussis and experienced drug hypersensitivity and cipro [ciprofloxacin] and experienced drug hypersensitivity. The patient was allergic to cipro and pertussis vaccine, and bees. No covid prior vaccination. No covid tested post vaccination. On 29Sep2021 at 14:00 (24 hours post vaccination), the patient experienced vomiting, nausea, chills, body aches, large swollen lymph node in arm pit, swelling and pain in neck and shoulder, fever, headache, extreme fatigue. The patient did not receive any treatment for the reported event. Outcome of the events was recovered with sequelae.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Arthralgia
Clinical narrative: two sores on both knees; This is a spontaneous report received from a contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date, two weeks before the time of report as dose number unknown, single for COVID-19 immunisation; dupilumab (DUPIXENT), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient developed two sores on both knees. The patient was not sure whether it was from the vaccine or the DUPIXENT. The patient was unable to speak to RPH as she was at work. The action taken in response to the event and for dupilumab was unknown. The clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Immunisation, Off label use, Pruritus, Rash
Clinical narrative: Hives; Rash; Itching; Allergic reaction; I received the 3rd shot for the Pfizer, the booster; I received the 3rd shot for the Pfizer, the booster; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported, Expiration date: unknown), via an unspecified route of administration on 16Sep2021 as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (Lot number and expiration date not reported) as dose 1, single and second dose of bnt162b2 (Lot number and expiration date not reported) as dose 2, single, both via an unspecified route of administration on an unknown date for COVID-19 immunization. On 05Oct2021, the patient got an allergic reaction, a rash, hives, and itching. Patient wanted to know if that was possible that after three weeks, he gets a reaction. The outcome of events was unknown.  QR comment: Reporter type was not available over the call, hence reporter type was captured as consumer or non-healthcare professional by default.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; Rash; Itching; Allergic reaction; I received the 3rd shot for the Pfizer, the booster; I received the 3rd shot for the Pfizer, the booster; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported, Expiration date: unknown), via an unspecified route of administration on 16Sep2021 as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (Lot number and expiration date not reported) as dose 1, single and second dose of bnt162b2 (Lot number and expiration date not reported) as dose 2, single, both via an unspecified route of administration on an unknown date for COVID-19 immunization. On 05Oct2021, the patient got an allergic reaction, a rash, hives, and itching. Patient wanted to know if that was possible that after three weeks, he gets a reaction. The outcome of events was unknown.  QR comment: Reporter type was not available over the call, hence reporter type was captured as consumer or non-healthcare professional by default.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on stomach; This is a spontaneous report from a contactable consumer or other non-health-care-professional (patient). A 24-year-old non-pregnant female patient received BNT162B2 (Pfizer COVID-19 Vaccine Formulation: Solution for Injection Batch/Lot number: Unknown Expiration Date: Unknown), via an unspecified route of administration, administered in Right Arm on 05Oct2021 (at the age of 24-year-old), as DOSE 1, SINGLE for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient received influenza vaccine via an unspecified route of administration, administered in Arm Left on 05Oct2021, at unspecified dose for an unspecified indication. The patient medical history was not reported. The patient had no covid prior vaccination. Concomitant medication(s) included Paroxetine; Buspirone Multi for her "Aller-flo" and Ethinylestradiol, levonorgestrel (SRONYX), all taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced drug hypersensitivity. Patient did not receive any other vaccine in four weeks. The patient experienced rash on stomach on 06Oct2021. The patient was not tested for covid post vaccination. No treatment was received to treat the event. Outcome of event was resolving at the time of this report.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Immunisation, Lymphadenopathy, Off label use, Pyrexia
Clinical narrative: swollen lymph node under armpit (size of orange/grapefruit); fever; chills; Off-label use; Booster; This is a spontaneous report from a contactable consumer (patient). A 32-years-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: 301258a) via an unspecified route of administration, administered in Arm Left on 06Oct2021 at 11:45 (at the age of 32-year-old) as dose 3 (booster), single for COVID-19 immunization and received influenza vaccine (FLU), via an unspecified route of administration on 06Oct2021 (Batch/Lot Number: ut7325la), as dose 1, single for an unspecified indication. The medical history and concomitant medications were not reported. Patient had no known allergies. The patient received first dose of BNT162B2 on 12Mar2021 (lot number:en6205, administered on arm left) and received second dose on 20Feb2021 (lot number:el9266, administered on arm left) for covid-19 immunisation. . The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 06Oct2021 at 11:45 the patient experienced off-label use and booster. On 07Oct2021 at 14:00 the patient experienced swollen lymph node under armpit (size of orange/grapefruit), fever and chills. Patient did not receive treatment for the events. The outcome of the events swollen lymph node under armpit (size of orange/grapefruit), fever and chills was not resolved. No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain
Clinical narrative: minor aches and pain; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 59-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection Batch/Lot number) via an unspecified route of administration on an unspecified date (at the age of 59 year) as dose 2, single and first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection Batch/Lot number)  via an unspecified route of administration on an unspecified date (at the age of 59 year) as dose 1, single for COVID-19 immunisation. The patient  received tofacitinib citrate (XELJANZ XR, Formulation: Prolonged-release tablet, Strength 11 mg), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at a dose of 11 mg for an unspecified indication. The patient medical history was no reported and concomitant medication were not reported. It was reported that the patient bought relief factor to relieve of minor aches and pain. Action taken with tofacitinib citrate was unknown. The outcome of event was unknown.  No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained.
Sex: U
Vaccine: COVID19, UNK, UNK
Symptoms: Dizziness, Feeling abnormal, Headache, Nausea
Clinical narrative: Nausea; I am nauseous; Headache; Dizziness; I''m dizzy; I feel really weird like I threw up; This is a spontaneous case received from a contactable consumer (Patient) via Pfizer sponsored program. A 61-year-old patient of unspecified gender received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 04Oct2021 as dose 1, single for COVID-19 immunization; oxycodone (OXYCODONE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 10 mg, 4x/day for an unspecified indication; lisinopril (LISINOPRIL), route of administration, start and stop date, batch/lot number and dose were not reported for blood pressure measurement . The patient medical history included hearing disability. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced nausea, headache and dizziness and reported that felt really weird like threw up. It was reported that, patient felt really weird like threw up yesterday and hadn't thrown up, patient didn't remember the last time had thrown up like that, patient was nauseous, dizzy, it was just really affected the patient. Patient wanted to know if it was okay to get the second shot and took 3 other medications, took blood pressure medication Lisinopril and took Oxycodone and Morphine. So patient wondered if anything had a reaction with that. Patient was little hard of hearing, and took them due to disability and was very scared to get the COVID-19 vaccine. The action taken in response to the event(s) for oxycodone and lisinopril was unknown. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Wrong product administered
Clinical narrative: She received a booster dose of Pfizer/Biontech COVID-19 vaccine,; She received a booster dose of Pfizer/Biontech COVID-19 vaccine; She received a booster dose of Pfizer/Biontech COVID-19 vaccine; a flu shot was administered, instead of COVID-19; This is a spontaneous report from a contactable consumer or other non hcp.     A adult female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection(Batch/Lot number was not reported), dose 3 intramuscularly, administered in Arm Left on 10Sep2021 (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at  for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.It was Reported that, on 10Sep2021, The patient experienced she received a booster dose of pfizer/biontech covid-19 vaccine with outcome of unknown , she received a booster dose of pfizer/biontech covid-19 vaccine, interchange of vaccine products along with immunization, a flu shot was administered, instead of covid-19  on 10Sep2021 with outcome of unknown.  Therapeutic measures were taken as a result of she received a booster dose of pfizer/biontech covid-19 vaccine, (off label use), she received a booster dose of pfizer/biontech covid-19 vaccine (interchange of vaccine products), a flu shot was administered, instead of covid-19 (wrong product administered).case was assesses as non serious.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis, Scab, Skin laceration
Clinical narrative: very mild psoriasis on my hands for years/after my Vaccination my hands have gone crazy; cuts and crusting skin; cuts and crusting skin; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 64-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER2613, Expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 28Mar2021 12:30 (age at vaccination was 64 years) as dose 2, single for COVID-19 immunization. The patient's medical history included none from an unknown date and unknown if ongoing. The patient have known allergies. The patient did not receive any concomitant medications or other medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously carrageenan and experienced drug hypersensitivity. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6205, Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 07Mar2021 15:00 (age at vaccination was 64 years) as dose 1, single for COVID-19 immunization. On 05Apr2021 the patient experienced very mild psoriasis on my hands for years/after my vaccination my hands have gone crazy and cuts and crusting skin. The events were non serious. Patient have had very mild psoriasis on his hands for years. Patient never had it checked out because he just assumed that it was rough/dry skin from working hard. Several weeks after his Vaccination his hands have gone crazy. Patient have cuts and crusting skin. His right hand was worse and they are driving him crazy. Nothing was working and he will be at the doctors soon. No treatment was received for the adverse events. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Off label use, Product use issue
Clinical narrative: Lump in right armpit; Product use for unapproved combination; Off-Label Use; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received bnt162b2 (COVID 19 Pfizer), dose 2 via an unspecified route of administration, administered in right arm on 01Oct2021 12:00 (Batch/Lot number was not reported) as dose 2, single at the age of 34 years old for COVID-19 immunisation; influenza vaccine, via an unspecified route of administration administered in right arm on 01Oct2021 (Batch/Lot number was not reported, at unspecified dose for immunisation. The patient was not pregnant. Medical history included chronic hives, possible lupus. No known allergies. There were no concomitant medications in two weeks. Historic vaccine was bnt162b2 administered in right arm on 08Sep2021 as dose 1, single at the age of 34 years old for COVID-19 immunization. No other vaccine in four weeks. The patient experienced lump in right armpit on 09Oct2021 20:00. No treatment received. No covid prior vaccination. No covid tested post vaccination. The outcome of events was unknown.  The lot number for bnt162b2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Pain in extremity
Clinical narrative: I got my third shot the booster shot not the second shot; I got my third shot the booster shot not the second shot; Sore arm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date were unknown), via an unspecified route of administration on 08Oct2021 as dose 3 (booster), single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sore arm on an unknown date. On an unspecified date, the patient experienced I got my third shot the booster shot not the second shot. Consumer stated, "I got an email today saying that, confirming my second COVID dose given yesterday. It was my third dose not my second". Consumer stated, "The sore arm. All I wanna do is get the records straight that I got my third shot the booster shot not the second shot". The outcome of the events were unknown.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Anger, Confusional state, Depressed mood, Dizziness, Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: 30130D7), dose 3 via an unspecified route of administration, administered in Arm Right on 07Oct2021 07:55 as dose 3 (booster), single for covid-19 immunisation. Medical history included asthma Stated that he has had asthma for a few years. Stated that he was diagnosed two years ago.The patient's concomitant medications were not reported. Patient previously took first dose 1 and second dose of bnt162b2 (BNT162B2, solution for injection), via unspecified route of administration, administered on unknown date (Batch/Lot Number: unknown), as single dose for covid-19 immunisation. It was reported that, on 07Oct2021 20:00 patient experienced tired, dizzy, nauseous and had confusion, about 5 minutes after the shot at 8:00pm. Stated that he felt depressed and angry after 8pm.The outcome of the event malaise was unknown and rest all other events were not recovered. Follow-Up (15Oct2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: 30130D7), dose 3 via an unspecified route of administration, administered in Arm Right on 07Oct2021 07:55 as dose 3 (booster), single for covid-19 immunisation. Medical history included asthma Stated that he has had asthma for a few years. Stated that he was diagnosed two years ago.The patient's concomitant medications were not reported. Patient previously took first dose 1 and second dose of bnt162b2 (BNT162B2, solution for injection), via unspecified route of administration, administered on unknown date (Batch/Lot Number: unknown), as single dose for covid-19 immunisation. It was reported that, on 07Oct2021 20:00 patient experienced tired, dizzy, nauseous and had confusion, about 5 minutes after the shot at 8:00pm. Stated that he felt depressed and angry after 8pm.The outcome of the event malaise was unknown and rest all other events were not recovered. Follow-Up (15Oct2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: severe hair loss/getting handfuls coming out; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient experienced severe hair loss/getting handfuls coming out on an unspecified date with outcome of unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow-up (11Oct2021): This is a follow up spontaneous report from a contactable consumer. This consumer (patient) reported information included. Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Off label use
Clinical narrative: off label use; Patient had moderna and received 3rd pfizer vaccine; This is a spontaneous report from a contactable pharmacist. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 301358A) via intramuscular route of administration, administered in Arm Left on 03Oct2021 16:30 as dose 3 (booster), single for covid-19 immunisation; influenza vaccine inact sag 3v (FLUAD), via an unspecified route of administration on 03Oct2021 (Lot Number: 312849) at unspecified dose for an unspecified indication. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Patient has previously received 2 doses of Moderna vaccine. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not having covid prior vaccination and has not been covid tested post vaccination. On 03Oct2021 16:30, patient had moderna and received 3rd pfizer vaccine. Patient has not received any treatment for adverse event. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Erythema of eyelid, Headache, Heart rate increased, Influenza like illness
Clinical narrative: Muscle weakness; Unable to swallow; rapid heart beat; eyes red around rims of eyelids; Headache; flu like symptoms; body aches; sharp pains in quads; eyes red around rims of eyelids; stiffness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 08Oct2021 (Lot Number: FF2589) as DOSE 1, SINGLE for COVID-19 immunization at the age of 44 years old in the Pharmacy or Drug Store. Medical history included melanoma, cervical cancer carcinoma, current HSV1&2 and deathly allergic to escargot from an unknown date. The patient's concomitant medications were not reported. The patient previously took Keflex, clindamycin and tramadol and experienced anaphylactic response. The patient has not been COVID-9 tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. The patient experienced unable to swallow, rapid heart beat, eyes red around rims of eyelids then followed by severe headache, flu like symptoms - body aches, sharp pains in quads, muscle weakness and stiffness on 08Oct2021 18:30. The outcome of the events was recovering. The patient did not received treatment for the events.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Musculoskeletal stiffness, Myalgia, Ocular hyperaemia, Pain
Clinical narrative: Muscle weakness; Unable to swallow; rapid heart beat; eyes red around rims of eyelids; Headache; flu like symptoms; body aches; sharp pains in quads; eyes red around rims of eyelids; stiffness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 08Oct2021 (Lot Number: FF2589) as DOSE 1, SINGLE for COVID-19 immunization at the age of 44 years old in the Pharmacy or Drug Store. Medical history included melanoma, cervical cancer carcinoma, current HSV1&2 and deathly allergic to escargot from an unknown date. The patient's concomitant medications were not reported. The patient previously took Keflex, clindamycin and tramadol and experienced anaphylactic response. The patient has not been COVID-9 tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. The patient experienced unable to swallow, rapid heart beat, eyes red around rims of eyelids then followed by severe headache, flu like symptoms - body aches, sharp pains in quads, muscle weakness and stiffness on 08Oct2021 18:30. The outcome of the events was recovering. The patient did not received treatment for the events.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Heavy menstrual bleeding, Hypoaesthesia, Migraine, Nausea
Clinical narrative: I bled heavy clots for a week; A burning sensation throughout my entire body/burning of low back; numb hands and fingers but at times they tingle; numb hands and fingers but at times they tingle; migraine every morning; blurry vision; tachycard; severe nerve pain in my back; nausea; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: 301458A) as dose 1, single for COVID-19 immunization at pharmacy or drug store. Medical history was none. The patient did not receive any other vaccine within four weeks of Pfizer vaccine. There were no concomitant medications. The patient experienced a burning sensation throughout her entire body, burning of low back, numb hands and fingers but at times they tingle, severe nerve pain in her back, nausea and migraine every morning, blurry vision, tachycardia and she bled heavy clots for a week on 15Sep2021. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No treatment was received as a result of the events. The patient was not diagnosed with COVID prior to vaccination and had not been tested for COVID post vaccination. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Paraesthesia, Tachycardia, Vision blurred
Clinical narrative: I bled heavy clots for a week; A burning sensation throughout my entire body/burning of low back; numb hands and fingers but at times they tingle; numb hands and fingers but at times they tingle; migraine every morning; blurry vision; tachycard; severe nerve pain in my back; nausea; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: 301458A) as dose 1, single for COVID-19 immunization at pharmacy or drug store. Medical history was none. The patient did not receive any other vaccine within four weeks of Pfizer vaccine. There were no concomitant medications. The patient experienced a burning sensation throughout her entire body, burning of low back, numb hands and fingers but at times they tingle, severe nerve pain in her back, nausea and migraine every morning, blurry vision, tachycardia and she bled heavy clots for a week on 15Sep2021. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No treatment was received as a result of the events. The patient was not diagnosed with COVID prior to vaccination and had not been tested for COVID post vaccination. The outcome of the events was not recovered.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Immunisation
Clinical narrative: Severe headache; muscle aches; Joint pain; chills; Fever; Nausea; Vomiting; Fatigue; DOSE 3; DOSE 3; This is a spontaneous report from a contactable consumer (patient). This 71-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Arm Left on 08Oct2021 13:00 (Lot Number: FE3590) at age of 71-years-old as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization.  Medical history included diabetes, Blood pressure high (hbp), cholesterol, Transient ischaemic attack (TIA), Known allergies: sulfa. Concomitant medications included hctz; atenolol; rosuvastatin; clopidogrel; insulin. The patient previously received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, EP7534) on 19Mar2021 11:00 AM at age of 70-years-old in Left arm for COVID-19 immunization, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, EN6198) on 26Feb2021 11:00 AM at age of 70-years-old in Left arm for COVID-19 immunization, metformin and experienced allergies, azithromycin and experienced allergies, Betadine and experienced allergies. The patient experienced severe headache, muscle aches, joint pain, chills, fever, nausea, vomiting, fatigue on 08Oct2021 19:00. No treatment received for these events. No covid prior vaccination. No covid tested post vaccination. The outcome of the events severe headache, muscle aches, joint pain, chills, fever, nausea, vomiting, fatigue was recovering, of other events was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Off label use, Pyrexia, Vomiting
Clinical narrative: Severe headache; muscle aches; Joint pain; chills; Fever; Nausea; Vomiting; Fatigue; DOSE 3; DOSE 3; This is a spontaneous report from a contactable consumer (patient). This 71-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Arm Left on 08Oct2021 13:00 (Lot Number: FE3590) at age of 71-years-old as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization.  Medical history included diabetes, Blood pressure high (hbp), cholesterol, Transient ischaemic attack (TIA), Known allergies: sulfa. Concomitant medications included hctz; atenolol; rosuvastatin; clopidogrel; insulin. The patient previously received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, EP7534) on 19Mar2021 11:00 AM at age of 70-years-old in Left arm for COVID-19 immunization, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, EN6198) on 26Feb2021 11:00 AM at age of 70-years-old in Left arm for COVID-19 immunization, metformin and experienced allergies, azithromycin and experienced allergies, Betadine and experienced allergies. The patient experienced severe headache, muscle aches, joint pain, chills, fever, nausea, vomiting, fatigue on 08Oct2021 19:00. No treatment received for these events. No covid prior vaccination. No covid tested post vaccination. The outcome of the events severe headache, muscle aches, joint pain, chills, fever, nausea, vomiting, fatigue was recovering, of other events was unknown.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Back pain, Sinusitis
Clinical narrative: loss of smell after weeks of sinusitis that begin the next day after vaccination; loss of smell after weeks of sinusitis that begin the next day after vaccination; severe back pain; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), dose 2, via an unspecified route of administration, administered in the left arm on 24Aug2021 at 10:00 (Batch/Lot number was not reported) at the age of 31-years-old, single, for COVID-19 immunization. The patient had no relevant medical history. The patient had no known allergies, did not have COVID prior to vaccination, and did not receive any other vaccine in four weeks. There were no concomitant medications (no other medications in two weeks). The patient received the first dose of BNT162B2 on 04Aug2021 at 10 AM (Lot number: FA9585) in the left arm. The patient experienced loss of smell after weeks of sinusitis that began the next day after vaccination and severe back pain on 25Aug2021 at 18:00. The patient did not receive any treatment for the events. The patient was not tested for COVID after the vaccination. Outcome of the events was not recovered. The case was reported as serious (disability or permanent damage).  The lot number for BNT162B2 was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site inflammation, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer or other non healthcare professional from a Pfizer sponsored Program  Support. A 94-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: not reported, expiration date: not reported) via an unspecified route of administration, administered in Arm Left on 07Oct2021 as dose 3 (booster), single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced swelling at injection site, redness at injection, experiencing the arm where he received the injection is inflamed and swollen for the past 5 days. The arm swelled and it was very red and has been lasting about 3 or 4 days now and it was still there. Clinical outcome of the event was updated as unknown. The lot number for vaccine was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Haematemesis, Hypersensitivity, Pruritus, Syncope
Clinical narrative: couldn't breathe; fainted; threw up blood; allergic reaction all over her body; itchy; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 single dose on an unspecified date for Covid-19 immunization. The patient experienced fainted on 09Jul2021, couldn't breathe on 09Jul2021, threw up blood on 09Jul2021, itchy in Jun2021, allergic reaction all over her body on 09Jul2021. The patient was hospitalized for couldn't breathe from 21Jun2021 to an unknown date. Clinical course reported as patient was fine after first dose but two months after second dose experienced side effects of itchy and fainted. She was taken to the ER for treatment on 21Jun2021 01Jul2021 and 09Jul2021. Side effects specific to the third ER visit include couldn't breathe, threw up blood, fainted and had an allergic reaction all over her body. Patient never had heart problems before. The family and coworkers believe these side effects are from the vaccine. The patient was seen by her family doctor her said these were not side effects from the vaccine. Outcome of events was unknown. Events couldn't breathe, threw up blood, fainted required physician office visit.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Vaccination site swelling, Weight
Clinical narrative: asked how long was his heart going to hurt; left arm was swollen; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on an unspecified date (Batch/Lot Number: 301568A) as dose 1, single for covid-19 immunisation.  Medical history included blood pressure abnormal, triple bypass CABG 3 surgery on my heart 3 years ago (2019), pain in my hip and back. Concomitant medication(s) included nebivolol hydrochloride (BYSTOLIC) taken for blood pressure abnormal, start and stop date were not reported; oxycodone hydrochloride, paracetamol (PERCOCET) taken for pain in my hip and back, start and stop date were not reported. The patient stated that his left arm was swollen on an unspecified date. He asked how long was his heart going to hurt (onset unknown). There was no treatment received for the events Patient stated he was going to the ER. Outcome of the event of left arm swollen was unknown while for the other event was not recovered.   Follow-up attempts are completed. No further information is expected.