chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: extreme sensitivity to light; severe migraines; facial muscle spasms; facial muscle spasms; Extreme stomach pain in upper stomach; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 37-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: FF8814) via an unspecified route of administration, administered in Arm Left on 22Oct2021 16:00 (age 37-years at the time of vaccination), as single dose for COVID-19 immunization. Medical history included colitis ulcerative, generalised anxiety disorder, panic attack, bipolar hypertension retaining of fluid at times insomnia, patient previously took iodine and experienced drug hypersensitivity, allergy to chemicals, rubber sensitivity. Concomitant medication included sertraline hydrochloride (ZOLOFT), lithium, amitriptyline, quetiapine fumarate (SEROQUEL), metoprolol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior to vaccination. On 23Oct2021 20:30 the patient experienced extreme stomach pain in upper stomach, extreme sensitivity to light, severe migraines, and facial muscle spasms. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Apr2020 Nasal Swab, sars-cov-2 test: negative on 16Nov2020 Nasal Swab, sars-cov-2 test: negative on 29Aug2021 Nasal Swab, sars-cov-2 test: negative on 24Sep2021 Blood test done. The outcome of all the events was not recovered.  Follow-Up (01Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex reactivation, Immunisation, Off label use
Clinical narrative: Dose 3; Dose 3; Herpes Simplex reactivation; This is a spontaneous report from a contactable consumer (patient) who reported for herself.  A 66-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EW0191 and expiration date was not reported), dose 3 via an unspecified route of administration, administered in left arm on 27Sep2021 14:30 (Age at vaccination was 66 years) as dose 3 (booster), single for covid-19 immunisation. The facility where the most recent COVID-19 vaccine was administered was drug store. The device date was 26Oct2021. Medical history included coeliac disease, gluten sensitivity from an unknown date and unknown if ongoing. The patient was not diagnosed with covid-19 prior to vaccination. There were no concomitant medications. The patient did not receive any other vaccines within four weeks and any other medications within two weeks prior to the COVID vaccine. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was ENV199 and expiration date were not reported), via an unspecified route of administration, administered in left arm, on 19Mar2021 at 12:30 hours as dose 2, single and dose 1 via an unspecified route of administration (lot number was EL9264 and expiration date were not reported), administered in left arm, on 23Feb2021at 15:00 hours as dose 1, single for COVID-19 immunization. Age at vaccination for both the doses was 66 years. On an unspecified date in 2021 the patient experienced Herpes Simplex reactivation within a week of first two doses and 3 weeks after booster shot. The patient was not tested for covid-19 since vaccination. The patient took Valtrex as therapeutic measure. The outcome of event Herpes Simplex reactivation was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Fatigue, Headache, Nausea
Clinical narrative: Shot area swelled into a huge 3.5 inch hard ball under skin, alot of pain, heat , tenderness, redness; alot of pain; tenderness; redness; headaches; tiredness; nausea; joint pain; This is a spontaneous report from a contactable consumer or other non hcp. A 33-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0172), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 10:15 (at the age of 33-year-old), as dose 2, single for COVID-19 immunization administered at hospital. The patient's medical history included food allergy, Ginger, cinnamon, turmeric, all spice, nutmeg, drug hypersensitivity, dermatitis contact, rubber sensitivity, hypoglycaemia, food allergy from an unknown date and unknown if ongoing. Other medical history was reported as gurd, anxiety, depression, covid-19, PCOS, Immune difficulties, digestive issues, malabsorbtion, constipation. The concomitant medications included trazodone (TRAZODONE), docusate sodium (STOOL SOFTENER) taken for an unspecified indication, start and stop date were not reported. Patient was also taking unspecified Womens multi vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0172) from an unknown date in Mar2021, for COVID-19 immunization, ciprofloxacin and experienced drug hypersensitivity, hycosan and experienced drug hypersensitivity. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced shot area swelled into a huge 3.5 inch hard ball under skin, a lot of pain (pain), heat, tenderness (tenderness), redness, headache, tiredness, nausea joint pain on 03May2021 18:00. Shot area swelled into a huge 3.5 inch hard ball under skin, alot of pain, heat, tenderness, redness. Was getting slowly worst every day untill day 5 when it started to get smaller. She kept applying ice and Benadryl cream. Also about 3 inches under her puncture area there was a fluid like pocket forming. It was about 2.5 inches round and squishy, also painful. 6 days out from shot and swelling of both balls has gone down 75% along with all other symptoms. She also had headaches, tiredness, nausea, joint pain. She had also noticed an increase in heart burn since my first shot in March, and period changes as well. The events were non-serious. No treatment was received for events. Outcome of the events was reported as recovered with sequelae on an unspecified date in 2021..  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling, Tenderness
Clinical narrative: Shot area swelled into a huge 3.5 inch hard ball under skin, alot of pain, heat , tenderness, redness; alot of pain; tenderness; redness; headaches; tiredness; nausea; joint pain; This is a spontaneous report from a contactable consumer or other non hcp. A 33-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0172), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 10:15 (at the age of 33-year-old), as dose 2, single for COVID-19 immunization administered at hospital. The patient's medical history included food allergy, Ginger, cinnamon, turmeric, all spice, nutmeg, drug hypersensitivity, dermatitis contact, rubber sensitivity, hypoglycaemia, food allergy from an unknown date and unknown if ongoing. Other medical history was reported as gurd, anxiety, depression, covid-19, PCOS, Immune difficulties, digestive issues, malabsorbtion, constipation. The concomitant medications included trazodone (TRAZODONE), docusate sodium (STOOL SOFTENER) taken for an unspecified indication, start and stop date were not reported. Patient was also taking unspecified Womens multi vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0172) from an unknown date in Mar2021, for COVID-19 immunization, ciprofloxacin and experienced drug hypersensitivity, hycosan and experienced drug hypersensitivity. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced shot area swelled into a huge 3.5 inch hard ball under skin, a lot of pain (pain), heat, tenderness (tenderness), redness, headache, tiredness, nausea joint pain on 03May2021 18:00. Shot area swelled into a huge 3.5 inch hard ball under skin, alot of pain, heat, tenderness, redness. Was getting slowly worst every day untill day 5 when it started to get smaller. She kept applying ice and Benadryl cream. Also about 3 inches under her puncture area there was a fluid like pocket forming. It was about 2.5 inches round and squishy, also painful. 6 days out from shot and swelling of both balls has gone down 75% along with all other symptoms. She also had headaches, tiredness, nausea, joint pain. She had also noticed an increase in heart burn since my first shot in March, and period changes as well. The events were non-serious. No treatment was received for events. Outcome of the events was reported as recovered with sequelae on an unspecified date in 2021..  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Breast pain, Inappropriate schedule of product administration, Menstruation irregular
Clinical narrative: Injection site hurt every now and then; I have not had a period,; my breast hurt; My sleep is disturbed. I only sleep a total of about 3 hours a night; Vision in my right eye is blurry; im having back & joint pain; im having back & joint pain; The patient administered first and second doses on same date 29Mar2021; This is a spontaneous report from a contactable consumer(patient). A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 29Mar2021 at 15:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:EP6955 ) via an unspecified route of administration in the right arm on 29Mar2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient reported the Facility type Vaccine was Doctor's office/urgent care. Medical history was not reported. The patient reported past drug event of known allergies was Naloxone. Concomitant medication within two weeks of vaccination included Subutex, xanax, vitamins, prebiotic taken for unspecified indication and start dates and stop dates were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Apr2021 at 02:30 the patient experienced not had a period, breast hurt, both injection site hurt every now and then, sleep is disturbed, and I only sleep a total of about 3 hours a night, Vision in my right eye is blurry and having back & joint pain. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Vaccination site pain, Vision blurred
Clinical narrative: Injection site hurt every now and then; I have not had a period,; my breast hurt; My sleep is disturbed. I only sleep a total of about 3 hours a night; Vision in my right eye is blurry; im having back & joint pain; im having back & joint pain; The patient administered first and second doses on same date 29Mar2021; This is a spontaneous report from a contactable consumer(patient). A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 29Mar2021 at 15:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:EP6955 ) via an unspecified route of administration in the right arm on 29Mar2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient reported the Facility type Vaccine was Doctor's office/urgent care. Medical history was not reported. The patient reported past drug event of known allergies was Naloxone. Concomitant medication within two weeks of vaccination included Subutex, xanax, vitamins, prebiotic taken for unspecified indication and start dates and stop dates were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Apr2021 at 02:30 the patient experienced not had a period, breast hurt, both injection site hurt every now and then, sleep is disturbed, and I only sleep a total of about 3 hours a night, Vision in my right eye is blurry and having back & joint pain. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Headache, Herpes zoster, Hypoaesthesia, Immunisation
Clinical narrative: As of today Friday 10/29/21 "I" have blisters on the left side of "my" face and am being monitored for eye involvement as it is on my ophthalmic nerve.; numbness on the left side of her face which turned out to be the start of shingles; On Monday 10/25/21 "I" developed a severe headache; pain; numbness on the left side of her face which turned out to be the start of shingles.; Booster dose; This is a spontaneous report from a contactable other hcp (patient). A 32-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: FF8839) via an unspecified route of administration, administered in Arm Right on 20Oct2021 (at the age of 32 year old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included covid-19 (Prior to vaccination, was the patient diagnosed with COVID-19?Yes). There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient previously taken amoxicillin/clavulanic acid (AUGMENTIN) and experienced rash as a child. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration on 22Jan2021 (at the age of 32-years-old) as dose 1, single and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration on 12Feb2021 (at the age of 32-years-old) as a dose 2, single for COVID-19 immunisation. On 25Oct2021, on Monday, the patient developed severe headache as well as pain and numbness on the left side of her face which turned out to be the start of shingles. On 29Oct2021, Friday, the patient had blisters on the left side of her face and she was being monitored for eye involvement as it was along the ophthalmic nerve. The adverse events resulted in doctor/other health care professional office/clinic visit. Patient received treatment with valaciclovir (VALACYCLOVIR) 1 gram thrice daily for 10 days and eyedrops. The outcome of the event events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: As of today Friday 10/29/21 "I" have blisters on the left side of "my" face and am being monitored for eye involvement as it is on my ophthalmic nerve.; numbness on the left side of her face which turned out to be the start of shingles; On Monday 10/25/21 "I" developed a severe headache; pain; numbness on the left side of her face which turned out to be the start of shingles.; Booster dose; This is a spontaneous report from a contactable other hcp (patient). A 32-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: FF8839) via an unspecified route of administration, administered in Arm Right on 20Oct2021 (at the age of 32 year old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included covid-19 (Prior to vaccination, was the patient diagnosed with COVID-19?Yes). There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient previously taken amoxicillin/clavulanic acid (AUGMENTIN) and experienced rash as a child. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration on 22Jan2021 (at the age of 32-years-old) as dose 1, single and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration on 12Feb2021 (at the age of 32-years-old) as a dose 2, single for COVID-19 immunisation. On 25Oct2021, on Monday, the patient developed severe headache as well as pain and numbness on the left side of her face which turned out to be the start of shingles. On 29Oct2021, Friday, the patient had blisters on the left side of her face and she was being monitored for eye involvement as it was along the ophthalmic nerve. The adverse events resulted in doctor/other health care professional office/clinic visit. Patient received treatment with valaciclovir (VALACYCLOVIR) 1 gram thrice daily for 10 days and eyedrops. The outcome of the event events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Interchange of vaccine products, Off label use, Skin discolouration
Clinical narrative: right eye was swollen with some discoloration on the eye lid and outer skin surrounding the eye/feeling pressure related to the swelling; right eye was swollen with some discoloration on the eye lid and outer skin surrounding the eye; this patient received the Jansen COVID-19 vaccine as her primary COVID-19 vaccination.; this patient received the Jansen COVID-19 vaccine as her primary COVID-19 vaccination.; This is a spontaneous report from a contactable pharmacist via medical information team.  A 54-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration, on 30Oct2021 (Saturday) (age at vaccination: 54 years), as a dose 2 (booster), single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient historical vaccine includes JANSSEN COVID-19 VACCINE started on an unspecified date for primary COVID-19 vaccination. On 31Oct2021 (Sunday), the patient started having a strange reaction.The reporter stated that the patient woke up Sunday and noticed that her right eye was swollen with some discoloration on the eye lid and outer skin surrounding the eye.The patient reported no changes in vision and no pain associated with the swelling but did endorse feeling pressure related to the swelling. The reporter also stated that there was no drainage from the eye. The reporter told the patient to take a Benadryl in the event that this may be a delayed allergic reaction.The reporter spoke with the patient this morning and her symptoms were still the same with no improvement.The caller advised the patient to see her medical doctor for evaluation.The caller would like to know if swelling of the eye one day post vaccination was a side effect that had been reported with the Pfizer COVID-19 vaccine.The reporter declined warm transfer at this time due to being at work with patients waiting on her at the pharmacy. The caller did ask for the website for online reporting. Provided caller with withheld, however, she had not reported online at this time yet. She states that she was currently reporting online to VAERS at the time of this call. Reportedly the response provided regarding delayed non-severe allergic reactions including swelling of the face. The outcome was not recovered for the event right eye was swollen with some discoloration on the eye lid and outer skin surrounding the eye.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Heart rate, Hypertension, Immunisation
Clinical narrative: Booster; some blood pressure changes/blood pressure is a little higher/ around 123/89.  The other day I checked it and left arm readings were 199/93, 199/97/ blood pressure increase was noticed not too long after my Pfizer Covid 19 booster dose; tired; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration on 20Oct2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; tafamidis (VYNDAMAX), via an unspecified route of administration from an unspecified date to an unspecified date, at 61 mg, 4x/day for an unspecified indication. Medical history included pacemaker and defibrillator both before tafamidis, ongoing stress; Patient lived with cousin who was hospitalized and passed away from COVID about 3 weeks ago (as of 02Nov2021). Patient took a COVID test after cousin passed away and it came back negative. The test was done approximately a week before COVID booster shot (Oct2021). Concomitant medication included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included 1st dose of BNT162B2 on 23Mar2021 (age at vaccination was 52-year-old) and 2nd dose of BNT162B2 on 14Apr2021 (age at vaccination was 53-year-old), both for Covid-19 Immunization. Recently, patient had noticed some blood pressure changes based on blood pressure readings taken on an at home wrist monitor. The pulse was OK but blood pressure was a little higher. Typically, it was around 123/89 (2021). The other day patient checked it and left arm readings were 199/93, 199/97; right arm was lower but still high. It's never been over 200.Patient had been under a lot of stress this last month and blood pressure increase was noticed not too long after Pfizer Covid 19 booster dose. Patient just got a Pfizer covid 19 booster shot on 20Oct2021. He was tired but as days went on, he fought it off. Patient preferred not to report since he did not think the blood pressure changes were related to the medications but probably due to stress since patient had been on tafamidis for over a year and did not notice blood pressure changes then. All this was probably related to stress. Action taken in response to tafamidis was unknown. Outcome of tired was recovering. Outcome of other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Event hypertension is considered intercurrent and unrelated to BNT162B2 and tafamidis.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Booster; some blood pressure changes/blood pressure is a little higher/ around 123/89.  The other day I checked it and left arm readings were 199/93, 199/97/ blood pressure increase was noticed not too long after my Pfizer Covid 19 booster dose; tired; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration on 20Oct2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; tafamidis (VYNDAMAX), via an unspecified route of administration from an unspecified date to an unspecified date, at 61 mg, 4x/day for an unspecified indication. Medical history included pacemaker and defibrillator both before tafamidis, ongoing stress; Patient lived with cousin who was hospitalized and passed away from COVID about 3 weeks ago (as of 02Nov2021). Patient took a COVID test after cousin passed away and it came back negative. The test was done approximately a week before COVID booster shot (Oct2021). Concomitant medication included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included 1st dose of BNT162B2 on 23Mar2021 (age at vaccination was 52-year-old) and 2nd dose of BNT162B2 on 14Apr2021 (age at vaccination was 53-year-old), both for Covid-19 Immunization. Recently, patient had noticed some blood pressure changes based on blood pressure readings taken on an at home wrist monitor. The pulse was OK but blood pressure was a little higher. Typically, it was around 123/89 (2021). The other day patient checked it and left arm readings were 199/93, 199/97; right arm was lower but still high. It's never been over 200.Patient had been under a lot of stress this last month and blood pressure increase was noticed not too long after Pfizer Covid 19 booster dose. Patient just got a Pfizer covid 19 booster shot on 20Oct2021. He was tired but as days went on, he fought it off. Patient preferred not to report since he did not think the blood pressure changes were related to the medications but probably due to stress since patient had been on tafamidis for over a year and did not notice blood pressure changes then. All this was probably related to stress. Action taken in response to tafamidis was unknown. Outcome of tired was recovering. Outcome of other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Event hypertension is considered intercurrent and unrelated to BNT162B2 and tafamidis.
Sex: U
Vaccine: COVID19
Symptoms: Eye swelling, Immunisation
Clinical narrative: booster; Swollen eyes; This is a spontaneous report from a contactable pharmacist.   A patient of an unspecified age and gender received BNT162B2 (Pfizer COVID-19 Vaccine Formulation: Solution For injection Batch/Lot Number: FH8020 Expiration Date: Unknown) via an unspecified route of administration on an unspecified date as dose 3 (booster), single for COVID-19 immunization. Patient previously received BNT162B2 (Pfizer COVID-19 Vaccine) on an unspecified date as dose 1, single and dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Swollen eyes and she has given the vaccine for booster. The clinical outcome of the event was unknown.  Pharmacist was unwilling to complete the report. Further probing could not be done. Hence, limited information was available over the call.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Accident, Investigation, Myalgia, Needle issue, Peripheral swelling
Clinical narrative: accident; drowsiness; injection site pain; muscle pain; rash; swollen itchy arm; they used a different type of needle bigger the regular needle; Weight gain:; This is a spontaneous report from a contactable consumer.   A 61-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 08Oct2021 (Batch/Lot Number: FC3184) as DOSE 1, SINGLE for covid-19 immunisation  .  Medical history included hypertension from an unknown date and unknown if ongoing Verbatim: High Blood Pressure , anxiety from an unknown date and unknown if ongoing Verbatim: Anxiety. Concomitant medication(s) included tetanus vaccine toxoid (TETANUS TOXOID) taken for a mini accident, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported.  The patient experienced a mini accident (accident) (medically significant) on an unspecified date with outcome of unknown , drowsiness (somnolence) (non-serious) on an unspecified date with outcome of unknown , injection site pain (vaccination site pain) (non-serious) on an unspecified date with outcome of unknown , muscle pain (myalgia) (non-serious) on an unspecified date with outcome of unknown , rash (rash) (non-serious) on an unspecified date with outcome of unknown , swollen itchy arm (peripheral swelling) (non-serious) on an unspecified date with outcome of unknown , they used a different type of needle bigger the regular needle (needle issue) (non-serious) on an unspecified date with outcome of unknown , weight gain: (weight increased) (non-serious) on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included investigation: unknown results   on   When probed for any Laboratory test, consumer stated, "No, the immunologist did a blood work two days after the shot, which I did on Monday.". The outcome of the events was unknown.   Follow-Up (09Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Somnolence, Vaccination site pain, Weight increased
Clinical narrative: accident; drowsiness; injection site pain; muscle pain; rash; swollen itchy arm; they used a different type of needle bigger the regular needle; Weight gain:; This is a spontaneous report from a contactable consumer.   A 61-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 08Oct2021 (Batch/Lot Number: FC3184) as DOSE 1, SINGLE for covid-19 immunisation  .  Medical history included hypertension from an unknown date and unknown if ongoing Verbatim: High Blood Pressure , anxiety from an unknown date and unknown if ongoing Verbatim: Anxiety. Concomitant medication(s) included tetanus vaccine toxoid (TETANUS TOXOID) taken for a mini accident, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported.  The patient experienced a mini accident (accident) (medically significant) on an unspecified date with outcome of unknown , drowsiness (somnolence) (non-serious) on an unspecified date with outcome of unknown , injection site pain (vaccination site pain) (non-serious) on an unspecified date with outcome of unknown , muscle pain (myalgia) (non-serious) on an unspecified date with outcome of unknown , rash (rash) (non-serious) on an unspecified date with outcome of unknown , swollen itchy arm (peripheral swelling) (non-serious) on an unspecified date with outcome of unknown , they used a different type of needle bigger the regular needle (needle issue) (non-serious) on an unspecified date with outcome of unknown , weight gain: (weight increased) (non-serious) on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included investigation: unknown results   on   When probed for any Laboratory test, consumer stated, "No, the immunologist did a blood work two days after the shot, which I did on Monday.". The outcome of the events was unknown.   Follow-Up (09Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Off label use
Clinical narrative: booster; booster; Diagnosed with COVID; Diagnosed with COVID; This is a Solicited report from a Non-interventional study report from a FACILITATED COLLECT based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # 21K-163-4086192-00). A contactable consumer (patient) reported a 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 3 intramuscular on an unspecified date in 2021 (Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 29Jan2021 (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 05Jan2021 (Batch/Lot number was not reported), all as single dose for covid-19 immunisation; adalimumab (HUMIRA) subcutaneous from an unspecified date (Batch/Lot number was not reported) for moderate to severe rheumatoid arthritis. Medical history included moderate to severe rheumatoid arthritis. The patient's concomitant medications were not reported. On unknown dates, the patient was tested positive for COVID and experienced COVID. In 2021, the patient was diagnosed with COVID after booster shot. The patient underwent lab tests and procedures which included COVID-19 test with positive in 2021 and COVID-19 test with positive on an unknown date. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. The outcome of event was recovered.     The reporter's causality for the event(s) of diagnosed with COVID after booster shot with adalimumab was a reasonable possibility.   The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available in narrative the reported  event of Booster, Off label use and lack of efficacy of suspected vaccine is assessed as related.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient received 2 doses of the Pfizer covid vaccine about 6 months ago. They also got covid infection; Patient received 2 doses of the Pfizer covid vaccine about 6 months ago. They also got covid infection; This is a spontaneous report from a contactable Pharmacist. An adult female patient (over age 18) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on unspecified date in 2021 (about 6 months ago) as single dose, first dose via an unspecified route of administration on unspecified date in 2021 (about 6 months ago) as single dose, for covid-19 immunization. The patient medical history and concomitant medications were not reported. Pharmacist would like to know if there was a timeframe or interval between receiving monoclonal antibodies and a booster dose of the Pfizer covid vaccine. Pharmacist reported that a female patient of unknown age but over age 18, wished to receive a booster dose of the Pfizer covid vaccine due to health conditions. Patient received 2 doses of the Pfizer covid vaccine about 6 months ago. She also got covid infection and received monoclonal antibodies as treatment on unspecified date in 2021. The time the antibodies were received was unknown. The outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 the suspect drug BNT162B2.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: ended up losing my baby at 32weeks and 5 days gestational period; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus/baby. This is a maternal report. A 22-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FF2593), via an unspecified route of administration, administered in Arm Left on 18Oct2021 at 18:45 (at the age of 22-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included asthma, eczema, known allergies: shellfish, peanuts and turkey. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: RC3183), administered in Arm Left on 27Sep2021 at 06:45 PM (at the age of 22-years-old) for COVID-19 immunisation.  The patient ended up losing her baby at 32weeks and 5 days gestational period on 22Oct2021 at 22:00. The event resulted in Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for the event for 3 days. The clinical course was as follows: the Friday after the patient received her final dose of the Pfizer vaccine, she ended up losing her baby at 32weeks and 5 days gestational period. She was told getting the covid vaccine would help but in reality, in her belief, she ended up losing her baby over the vaccine and it has been reported that she was not the only person to have this happen to. She blames the Pfizer vaccine to having lost her child and no one should ever have to go through that at any moment. The mother reported she became pregnant while taking bnt162b2. The mother was 32 Weeks pregnant at the onset of the event. The mother was due to deliver on 13Dec2021. The outcome of the event was unknown.    No follow up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Dizziness, Hypoaesthesia, Palpitations
Clinical narrative: My heart was racing like crazy; I couldn't speak.; my arms and hands were numb; I was also extremely dizzy; This is a spontaneous report from a contactable Consumer (patient). A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 28Oct2021 14:00 (Lot Number: FF2593) at the age of 40 years old as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included known allergies: Penicillin/Shellfish. No Covid prior vaccination. No other vaccine in four weeks. There were no concomitant medications.  On Sunday 31Oct2021 16:00, the patient ended up in the hospital. His heart was racing like crazy, his arms and hands were numb, he couldn't speak. He was also extremely dizzy. AE resulted in Emergency room/department or urgent care. It was unknown if treatment received. The outcome was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Had a positive COVID-19 diagnosis; Had a positive COVID-19 diagnosis; This is a spontaneous report from a contactable pharmacist (patient's wife). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 07May2021 (Batch/Lot Number: EW0176) as dose 2, single and on 16Apr2021 (Batch/Lot Number: EW0169) as dose 1, single; both via an unspecified route of administration vaccinated at the age of 37-years-old for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 30Oct2021, the patient had a positive COVID-19 diagnosis. The patient took two capsules of Decol in the morning and two capsules of Nicol at the night as treatment for the event. Outcome of events was unknown.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Impaired work ability, Nervous system disorder, Suspected COVID-19
Clinical narrative: experienced a breakthrough infection with Covid-19; experienced a breakthrough infection with Covid-19; long haul neurological issues from the Covid-19 infection; unable to work; This is a spontaneous report from a contactable consumer via a representative. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 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's medical history and concomitant medications were not reported. The reporter informed that a female received the Pfizer Covid-19 vaccine, however she experienced a breakthrough infection with Covid-19. The female was currently experiencing long haul neurological issues from the Covid-19 infection and she was unable to work. The reporter informed that the awareness date was on 11Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Immunisation, Loss of consciousness, Pyrexia
Clinical narrative: loss of conciousness; chills; fever of 102F; third dose; This is a spontaneous report from a non-contactable nurse (patient). A 55-year-old non-pregnant female patient received the third (booster) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: FF2590), via an unspecified route of administration on 18Oct2021 (at the age of 55-years-old) at dose 3 (booster), single in the left arm for COVID-19 immunization. The patient has no medical history and concomitant medications. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot No: EL0142) received on 29Dec2021 (at the age of 54-years-old),and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot No: EL1283) received on 15Jan2021 (at the age of 54-years-old); both for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient has no known allergies, did not receive any other vaccines within 4 weeks prior to the COVID-vaccine, and has no other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 18Oct2021 at 22:00, the patient experienced loss of consciousness, chills, and fever of 102F. No treatment was received for the events. The patient underwent lab tests and procedures which included: Body temperature on 18Oct2021: 102 Fahrenheit; and COVID-19 nasal swab on 23Sep2021: negative. Outcome of the events was recovered on Oct2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: loss of conciousness; chills; fever of 102F; third dose; This is a spontaneous report from a non-contactable nurse (patient). A 55-year-old non-pregnant female patient received the third (booster) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: FF2590), via an unspecified route of administration on 18Oct2021 (at the age of 55-years-old) at dose 3 (booster), single in the left arm for COVID-19 immunization. The patient has no medical history and concomitant medications. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot No: EL0142) received on 29Dec2021 (at the age of 54-years-old),and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot No: EL1283) received on 15Jan2021 (at the age of 54-years-old); both for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient has no known allergies, did not receive any other vaccines within 4 weeks prior to the COVID-vaccine, and has no other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 18Oct2021 at 22:00, the patient experienced loss of consciousness, chills, and fever of 102F. No treatment was received for the events. The patient underwent lab tests and procedures which included: Body temperature on 18Oct2021: 102 Fahrenheit; and COVID-19 nasal swab on 23Sep2021: negative. Outcome of the events was recovered on Oct2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: neuropathy in my left arm; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FF2589), in the left arm on 27Sep2021 at 12:00 (at the age of 41-years-old) at dose 1, single for COVID-19 immunisation. Medical history included lung cancer and Crohn's disease. Patient had not COVID prior vaccination and no COVID tested post vaccination. Known allergies reported as none. The patient did not receive other vaccine in four weeks; concomitant medications included unspecified other medications in two weeks. The patient experienced neuropathy in his left arm since the first dose, on 30Sep2021 at 02:00. The neuropathy was very painful at times during sleeping. The event resulted in doctor or other healthcare professional office/clinic visit. A medication was received to treat the event. The patient then received the second dose of BNT162b2 (lot number: FH8027) in the left arm on 18Oct2021 at 12:00. The patient had not recovered from the event.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive covid test result received on03Nov2021; positive covid test result received on03Nov2021; This is a spontaneous report from a contactable consumer. A 58-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Right on 22Mar2021 13:15 (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 intramuscular, administered in Arm Left on 01Mar2021 13:15 (Batch/Lot number was not reported) as DOSE 1,SINGLE at the age of 58-years-old for covid-19 immunisation.  Medical history included Known allergy: PCN.The patient's concomitant medications were not reported.  The patient experienced positive covid test result received on 03Nov2021.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 03Nov2021 Nasal Swab. Outcome of events was unknown. Therapeutic measures were taken as a result of all events.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.