chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Rash, Vasculitis
Clinical narrative: vasculitis; Rash All over Body; This is a spontaneous report from a contactable consumer (Patient). A 69-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 21May2021 at the age of 69-years-old (Lot Number: EW0167) as single dose for COVID-19 immunization. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), First Dose, Anatomical Location: Left Arm, on 30Apr2021 at the age of 69-years-old (Lot Number: ER8731) for COVID-19 immunization. Medical History included ongoing Diabetes, ongoing Heart Trouble; 7 Bypasses, ongoing Vertigo, ongoing Sleep Apnea, ongoing Restless Leg Syndrome, ongoing High Blood Pressure, ongoing High Cholesterol, Lyme Disease. Concomitant medication reported as: "Caller states he is on a bunch of medications, but he doesn't feel they are relevant because he has been taking them for a long time, quite a few years." Caller states he got the shot and he has a rash all over his body there are little red dots everywhere, even his privates. Caller states he has been to a Dermatologist and a Rheumatologist and they don't know what it is. Caller states they took a biopsy and 15 vials of blood. Caller states it has gotten bigger and it is spreading. Caller states one part is changing shape, some are all dots and some look like scrapes. Caller states the ones that look like scrapes showed up Saturday. Caller states the Rheumatologist had him stop a couple of his medications and he put him on Benadryl and it didn't do him any good. Caller states he went to the Rheumatologist again today and they took 15 vials of blood. Caller states he asked him the rash could be a reaction from the Covid shot but he couldn't be sure. Caller states the doctor prescribed Prednisone, it is ready for him to pick up, he wants him to take it for 4 weeks and see him in 6 weeks. Starting in June head to toe rash, little red doses. Indicates flat, do not itch. All over body including privates. Pink, fade out then red again. Since beginning of Jun2021. HCP initially indicate vasculitis. Potential Duplicate AE. Rash All over Body was reported as worsened. The patient experienced rash all over body in May2021 with outcome of not recovered, vasculitis on an unspecified date with outcome of unknown.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Limb injury
Clinical narrative: My arm  beginning to hurt; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: FF8841) as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient reported "I didn't expected to get the Pfizer booster shot today, I was calling to make appointment for us to get it and they said oh we have an opening so I went in and I got it and they came with a yellow paper and it said something about don't take Tylenol or something before and I don't know if I get but now it's been some hours after my arm beginning to hurt but I didn't know whether you can take Tylenol after for a day because (voice incomprehensive)  that's what I wanna know". The event outcome was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Vomiting
Clinical narrative: Coughing; Throwing up; Complaining about her breathing; This is a spontaneous report from a contactable consumer or other non hcp.    A 95-years-old female patient received bnt162b2 (BNT162B2 PFIZER BIOTECH COVID 19 MRNA VACCINE SOLUTION FOR INJECTION), dose 3 via an unspecified route of administration on an immunisation. Medical history included dyspnoea. Patient has had breathing problems before and has been on breathing medicine. The patient's concomitant medications were not reported. It was reported that, the patient experienced coughing, throwing up, complaining about her breathing on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of coughing (cough), throwing up (vomiting), complaining about her breathing (dyspnoea). Patient has been taking plenty of fluids and drinking Gatorade.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus/ it was worsening and has continued; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as dose 3 (booster), single for COVID-19 immunisation. Medical history included tinnitus from Feb2021 and ongoing. The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 on 14Jan2021 and the second dose on 04Feb2021 for COVID-19 immunization and experienced Tinnitus. The patient called and reported a personal side effect from the COVID vaccine. He stated he got his first dose on 14Jan2021 and second dose on 04Feb2021, 3 weeks later. He stated that he had the onset of tinnitus and could not recall the exact date in there, all he can recall was it was the beginning of Feb2021 and could not recall if it was after the first or 2nd dose. He relayed that it lingered and now he got the booster last Thursday, 7 days ago (unspecified date in 2021) and the tinnitus became worse. He stated that he noticed last Friday that it was worsening and has continued. He has been researching and has seen a small number reporting but like over 10, 000 but based on how many have received the vaccine, it is not more than 1%. He stated that he is concerned for himself and for others. The outcome of the event was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Muscle twitching, Nerve injury, Prostate examination
Clinical narrative: body twitching; nerve damage; This is a spontaneous report from a contactable consumer (patient's wife). A 78-year-old male patient (reporter's husband) received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), second dose via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. Medical history included atrophy from an unknown date and unknown if ongoing, prostate infection from an unknown date and unknown if ongoing. The patient previous received first dose of bnt162b2(Batch/Lot number was not reported) for COVID-19 immunization and developed got sick. The patient's concomitant drug was not reported. The patient experienced body twitching, nerve damage on an unspecified date. She and her husband aged 78 received the second dose of the Pfizer BioNTech Covid 19 vaccine. Her husband, aged 78, nine days after the second dose developed body twitching and nerve damage which he is still experiencing. His primary doctor says to get the booster dose but his neurologist says to hold off. When probed about adverse events related to husband: Reporter stated, her husband he is not here and she didn't have his card. She was going to say 9 days after he had his second Pfizer. With the first one he got sick. With the second one about 9 days, 2 weeks later (as reported) he came down with muscle twitches, so he has been to every doctor and he has nerve damage now. He is about 5 (foot) 8 (inches) and about 185-186 (pounds). Other Medical conditions: Reporter stated, he has atrophic, now it's prostate and like other things that has come with him older. There are two labs test down the last one was the prostate and so the other one was and so one in his regard quest (further clarifications unknown). The patient underwent lab tests and procedures which included Lab test: unknown results, prostate: unknown results both on an unspecified date. The outcome of events was not resolved.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101450679 same patient, different event, different dose of vaccine
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cerebrovascular accident, Drug ineffective, Paralysis
Clinical narrative: had the virus twice; had the virus twice; stroke; paralyzed; This is a spontaneous report from a contactable consumer (patient's sister). A 95-year-old female patient 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 1, single, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history included COVID-19 (had the virus twice). The patient's concomitant medications were not reported. The reporter said the doctor wants her to give consent whether to allow the patient to take the booster dose, and the flu vaccine. She said they came to an agreement that her sister (patient) will not get the booster dose until she gets the antibiotics out of her system. With that, consumer wanted to know if her sister should still get the booster dose or if it would just put her in danger. The patient experienced stroke and was paralyzed. She had the virus twice and had already received both doses of the Pfizer-BioNTech Covid-19 Vaccine. The patient just got off antibiotics because of "Cipus." The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Hypersomnia, Pain in extremity
Clinical narrative: sleeping 10 hours a night; right arm is still very sore; has very poor appetite; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 21Oct2021 13:45 (lot number: 320308D; expiry date: unknown) at the age of 73-years-old, as dose 3 (BOOSTER), single for Covid-19 immunization. The patient had no relevant medical history and family history and was not taking concomitant medications. She had no change in medications, no change in nutritional intake and no significant change in nutritional intake. Patient does not smoke. There were no changes in medical conditions or her health and no exposure to anything. The vaccine was administered in a pharmacy grocery store. The patient previously received 1st dose BNT162B2 on 31Mar2021 (lot number: EP7533) and the 2nd dose on 21Apr2021 (lot number: EN6204) both administered in the right arm for COVID-19 immunization. After the 1st dose she had absolutely no side effects and may have slept well that night and then after the 2nd dose she had nothing regarding no side effects. The patient did not receive other vaccines on the same date as BNT162B2. The patient previously received influenza vaccine (FLUZONE) for immunisation. She had the flu shot for seniors 3 weeks before the 3rd dose of the Pfizer COVID Vaccine and the flu shot was Fluzone HD 65 plus and has the lot number on it of PF2021-22 injection 0.7mL with NDC 49281-0121-65 and it was administered on 28Sep2021. She had received flu shots for many years and never had any side effects from any vaccine or from the flu shots. Patient stated that she had her 3rd dose on 21Oct2021 which was last Thursday, and her right arm was still very sore. She was still sleeping 10 hours a night and only getting up one time and still has very poor appetite. She does not have nausea and does not have fever but still has the sore arm and was still sleeping which was very nice but thought she should do her part and report this. Her arm soreness was a little better and was in her right arm where all three doses of the Pfizer COVID vaccines were administered. She got the 3rd dose of the vaccine at 1:45pm or 1:50pm and by 6:00pm at night was when she started noticing the poor appetite and it was a little better today. The events did not require emergency room and Physician's Office visit. Outcome of the event sleeping 10 hours a night was not recovered, while for the other events was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Hyperthyroidism, Investigation, Thyroiditis, Thyroxine
Clinical narrative: asymptomatic hyperthyroidism; painless thyroiditis; This is a literature report from the Thyroid, abstracts, entitled: Painless thyroiditis after mRNA vaccination for severe acute respiratory syndrome coronavirus 2 (sars-cov-2).  Thyroid dysfunction has been described following SARS-CoV-2 infection, but data on thyroid dysfunction following SARS-CoV-2 vaccination are extremely limited. The author reported the first 3 cases of painless thyroiditis in patients shortly after receiving an mRNA vaccine for SARS-CoV-2. A 29-year-old female with history of Graves disease in remission and off methimazole, now euthyroid on levothyroxine 25 mcg/day for pre-conception optimization, presented with asymptomatic hyperthyroidism after labs drawn five days after her second dose of mRNA-SARS-CoV-2 vaccine(Pfizer) revealed TSH of 0.01 lIU/mL, FT4 of 3.15 ng/dL, TT3 of 162 ng/dL and a negative TSI index. She was asked to hold levothyroxine and labs obtained four weeks later showed normal FT4 and TT3. Awareness about the possibility of thyroiditis in the post vaccination period can help prevent initiation of medical therapy or large adjustments in thyroid medication doses and invites more frequent thyroid testing in patients in whom thyroid dysfunction is suspected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Hyperthyroidism and BNT162B2.  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.
Sex: F
Vaccine: COVID19
Symptoms: Tri-iodothyronine
Clinical narrative: asymptomatic hyperthyroidism; painless thyroiditis; This is a literature report from the Thyroid, abstracts, entitled: Painless thyroiditis after mRNA vaccination for severe acute respiratory syndrome coronavirus 2 (sars-cov-2).  Thyroid dysfunction has been described following SARS-CoV-2 infection, but data on thyroid dysfunction following SARS-CoV-2 vaccination are extremely limited. The author reported the first 3 cases of painless thyroiditis in patients shortly after receiving an mRNA vaccine for SARS-CoV-2. A 29-year-old female with history of Graves disease in remission and off methimazole, now euthyroid on levothyroxine 25 mcg/day for pre-conception optimization, presented with asymptomatic hyperthyroidism after labs drawn five days after her second dose of mRNA-SARS-CoV-2 vaccine(Pfizer) revealed TSH of 0.01 lIU/mL, FT4 of 3.15 ng/dL, TT3 of 162 ng/dL and a negative TSI index. She was asked to hold levothyroxine and labs obtained four weeks later showed normal FT4 and TT3. Awareness about the possibility of thyroiditis in the post vaccination period can help prevent initiation of medical therapy or large adjustments in thyroid medication doses and invites more frequent thyroid testing in patients in whom thyroid dysfunction is suspected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Hyperthyroidism and BNT162B2.  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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pruritus, Rash, Urticaria
Clinical narrative: Body rash like hives all over; Body rash like hives all over; itching; booster; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), at the age of 30 years old, via an unspecified route of administration in left arm on 25Oct2021 at 13:00 as dose 3 (booster), single for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Patient had no COVID prior vaccination. It was unknown if patient had known allergies. Medical history was acidity. Patient did not receive other vaccine in four weeks. Concomitant medication in two weeks included omeprazole taken for acidity. The patient previously received the first dose of BNT162B2 (lot number: unknown) on 29Mar2021 (at the age of 29 years old) and the second dose of BNT162B2 (lot number: unknown) on 19Apr2021 (at the age of 30 years old), both in left arm at single dose for COVID-19 immunisation. The patient experienced body rash like hives all over and itching on 26Oct2021 at 18:30. Patient had to go to urgent care for help and medication. Events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if COVID had been tested post vaccination. Therapeutic measures were taken as a result of events and included treatment with two injections, diphenhydramine hydrochloride (BENADRYL) and other was dexamethoson. Outcome of events body rash like hives all over and itching 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.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Pregnancy test, Ultrasound scan
Clinical narrative: miscarriage; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus. This is the maternal report.  A 34-year-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 06Oct2021 18:45 (Batch/Lot Number: FF8839) as dose 2, single for covid-19 immunisation. Patient received first dose of BNT162B2 on 24Aug2021 12:45 PM in left arm with lot number FC3183. No other vaccine in four weeks. None other medications in two weeks. None medical history. No Covid prior vaccination. Patient last menstrual date: 02Aug2021. Patient received a positive pregnancy test about two weeks after first vaccine at about 6 weeks pregnant. At an ultrasound at 8 weeks 4 days the baby was measuring small (about 7 weeks) and had a lower heart rate. At an ultrasound at 10 weeks the baby measured 7 weeks and 1 day with no heartbeat, resulting in a miscarriage. The event resulted in: healthcare professional office/clinic visit, Congenital anomaly or birth defect, and received treatment. NO covid tested post vaccination. The outcome of miscarriage was recovering as reported.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101551947 Same reporter/drug, different patient and event (fetus case).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chest pain, Fatigue, Investigation
Clinical narrative: Fatigue; joint pain; muscle pain; Some chest pain/tightness.; Some chest pain/tightness.; This is a spontaneous report from a contactable consumer (patient). A 53-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 15Sep2021 at 16:00 (Batch/Lot Number: FD8448) as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none known. No known allergies. Concomitant medication(s) included vitamin d nos (Vitamin D 5000IU daily) taken for an unspecified indication, start and stop date were not reported. No other vaccine in fourweeks. On 22Sep2021, at 16:00, the patient experienced fatigue, muscle and joint pain. Mostly muscle pain in his legs. Some chest pain/tightness. Office exam with X-ray and lab work. On 06Oct2021 16:00, patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in right arm (Batch/Lot Number: FC3182) as DOSE 2, SINGLE for covid-19 immunisation. No covid prior vaccination and not tested post vaccination The patient underwent lab tests and procedures which included investigation: unknown results and x-ray: unknown results on unknown dates. Therapeutic measures were taken as a result of all the events. The outcome of all the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, X-ray
Clinical narrative: Fatigue; joint pain; muscle pain; Some chest pain/tightness.; Some chest pain/tightness.; This is a spontaneous report from a contactable consumer (patient). A 53-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 15Sep2021 at 16:00 (Batch/Lot Number: FD8448) as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none known. No known allergies. Concomitant medication(s) included vitamin d nos (Vitamin D 5000IU daily) taken for an unspecified indication, start and stop date were not reported. No other vaccine in fourweeks. On 22Sep2021, at 16:00, the patient experienced fatigue, muscle and joint pain. Mostly muscle pain in his legs. Some chest pain/tightness. Office exam with X-ray and lab work. On 06Oct2021 16:00, patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in right arm (Batch/Lot Number: FC3182) as DOSE 2, SINGLE for covid-19 immunisation. No covid prior vaccination and not tested post vaccination The patient underwent lab tests and procedures which included investigation: unknown results and x-ray: unknown results on unknown dates. Therapeutic measures were taken as a result of all the events. The outcome of all the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Immunisation, Pruritus, Rash erythematous, Urticaria
Clinical narrative: booster; Itching; Rashes/rash was everywhere/comes up red; Welts; she felt like crap; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received 3rd dose of BNT162B2 (COMIRNATY) at single dose on 05Oct2021 at 58-year-old via an unknown route in left arm for COVID-19 immunization. Medical history included ongoing Hashimoto's disease which was diagnosed 25 years ago as of 28Oct2021. Concomitant drug was not provided. Historical vaccine included 1st and 2nd dose of COVID-19 Vaccine MANUFACTURER UNKNOWN for COVID-19 immunization.  Patient received the booster dose of the Pfizer Covid 19 vaccine on 05Oct2021, and as of 28Oct2021she was still having issues with itching, rashes and welts. The itching had gotten worse. She was told to take Zyrtec until the itching stopped and that it could be a couple weeks, but it had been 3 weeks and there was no improvement. She took a prednisone shot on 28Oct2021. Patient stated like she felt like crap, but everything really started three days after the booster shot.  Patient stated that the rash was everywhere. It was further reported that "someone said that this could be like when you scratch and it comes up red, when it started welting does that mean your histamines". Outcome of the events itching, rashes/rash was everywhere/comes up red, and welts was not resolved. Outcome of the other events was unknown.     The report was assessed as non-serious. The report was not related to a study or programme.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle contractions involuntary, Pain, Vaccination site pain
Clinical narrative: fasciculations at her left shoulder/The next day she was having fasciculations and all of her extremities as well as feeling fasciculations in glutes and left abdomen.; she started developing soreness at injection site; With the fasciculations, sometimes she experiences a pain which she characterizes as under her skin and sharp however fasciculations are sometimes not accompanied by pain.; This is a spontaneous report from a contactable Physician. A 14-year-old female patient (Pregnant: No) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose via intramuscular in left arm on 09Jul2021 and the second dose via unspecified route of administration on an unspecified date in 2021, both as single dose for COVID-19 immunization. The relevant medical history included seasonal allergies from unspecified date. Concomitant medications were not reported. On 09Jul2021 patient had first COVID Pfizer vaccine in left arm. During the day, she started developing soreness at injection site, and then started noticing fasciculations at her left shoulder. The next day she was having fasciculations and all of her extremities as well as feeling fasciculations in glutes and left abdomen. With the fasciculations, sometimes she experienced a pain which she characterized as under her skin and sharp however fasciculations were sometimes not accompanied by pain. She had her second Pfizer vaccine without worsening of her symptoms. The symptoms did continue and would happen multiple times per day. She would herself and noticed these while sitting at school, or when trying to fall asleep. Towards the end of July, she was given a 5-day course of muscle relaxants which significantly alleviated her symptoms. After this, she primarily only had symptoms in her legs, and only occasionally will had symptoms in the glutes, left side of her abdomen, L shoulder. The adverse event result in Doctor or other healthcare professional office/clinic visit. Treatment received for the events included muscle relaxants. The outcome of the events was not recovered.  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 limited information a contributory effect of the vaccine BNT162B2 to the reported event Fasiculation cannot be ruled out.  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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Investigation, Pain in extremity, Peripheral swelling
Clinical narrative: pain on the bottom of the feet disabled me from walking; Severe joint pain in low extremities; massive swelling of feet; pain on the bottom of the feet disabled me from walking; This is a spontaneous report from a contactable consumer. A 38-year-old female consumer (patient) reported for herself that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EW0186) via an unspecified route of administration in left arm on 08Jun2021 11:00AM at single dose for COVID-19 immunisation. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EW0185) via an unspecified route of administration in left arm on 18May2021 12:00PM for COVID-19 immunisation. Relevant medical history included hyperactive thyroid. Concomitant medications were not reported. On 30Jun2021 16:00 the patient had severe joint pain in low extremities, massive swelling of feet, pain on the bottom of the feet disabling her from walking, could not go down/up the stairs. The events resulted in doctor or healthcare professional office/clinic visit. The patient received prescriptions with a lot of tests and X-rays. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, it is unknown whether the patient has been tested for COVID-19. The events were resolving at the time of report.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: pain on the bottom of the feet disabled me from walking; Severe joint pain in low extremities; massive swelling of feet; pain on the bottom of the feet disabled me from walking; This is a spontaneous report from a contactable consumer. A 38-year-old female consumer (patient) reported for herself that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EW0186) via an unspecified route of administration in left arm on 08Jun2021 11:00AM at single dose for COVID-19 immunisation. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EW0185) via an unspecified route of administration in left arm on 18May2021 12:00PM for COVID-19 immunisation. Relevant medical history included hyperactive thyroid. Concomitant medications were not reported. On 30Jun2021 16:00 the patient had severe joint pain in low extremities, massive swelling of feet, pain on the bottom of the feet disabling her from walking, could not go down/up the stairs. The events resulted in doctor or healthcare professional office/clinic visit. The patient received prescriptions with a lot of tests and X-rays. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, it is unknown whether the patient has been tested for COVID-19. The events were resolving at the time of report.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Skin injury
Clinical narrative: Hurt a little; Little shot hole mark; This is a spontaneous report from a contactable consumer (patient's mother), via a Pfizer-sponsored program. A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was reported fine but hurts a little and had the little shot hole mark on an unknown date. The outcome of the events was unknown.   Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer. This consumer reported similar event for 3 patients. This is one of 3 reports. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced shingles on an unknown date after the vaccine, with outcome of unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101473111 same reporter/drug/event, different patient;US-PFIZER INC-202101473797 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting for her cousin's wife. This consumer reported similar event for 3 patients. This is one of 3 reports. A female patient, of unspecified age, received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), on an unspecified date, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. The patient experienced shingles on an unknown date, with outcome of unknown. The batch/lot number for BNT162B2 not provided and will be requested during follow-up. Sender's comments: Linked report(s): PFIZER INC-202101473111 same reporter/drug/event, different patient; PFIZER INC-202101473796 same reporter/drug/event, different patient.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: HORRIBLE cramps during cycle; This is a spontaneous report from a non-contactable Consumer (patient).   A 40-years-old non-pregnant female patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in Arm Left on 15Oct2021 16:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. First dose was received on 23Sep2021 (at the age of 40). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination, no covid tested post vaccination. Medical history was none. No known allergies. There were no concomitant medications.The patient experienced 'horrible cramps during cycle. I have never cramped before. Cramping to the point I feel like I'm going to passing out' on 28Oct2021 20:00. No treatment received. The event outcome was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: I had a severe allergic reaction, I ended up in the emergency room after; This is a spontaneous report from a contactable consumer (patient).   A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 27Oct2021 (at the age of 53-years-old) as single dose for covid-19 immunisation. Medical history included fallot's tetralogy, hypothyroidism, blood pressure abnormal. Concomitant medications included levothyroxine taken for hypothyroidism, start and stop date were not reported; atenolol taken for blood pressure abnormal, start and stop date were not reported; quinidine gluconate taken for an unspecified indication, start and stop date were not reported.  The patient experienced a severe allergic reaction, the patient ended up in the emergency room on an unspecified date with outcome of unknown.  At the emergency room they put her on IV and they gave her fluids.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (reporter's father).   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported. The patient experienced hives (medically significant) on an unspecified date with outcome of not recovered. The patient was perfectly healthy until he got your vaccine for Covid 19. Since the vaccine he has been covered in hives and has had to get steroids and antibiotics, but nothing was helping him. He never got the virus.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Computerised tomogram, Lymphadenopathy
Clinical narrative: She has a lymph node in her armpit where everything started that is a little enlarged; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as single dose at the age of 67-years-old for covid-19 immunisation; crizotinib (XALKORI), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 200 mg for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient stated she has another CAT scan scheduled for next month. She has a lymph node in her armpit where everything started that is a little enlarged. It was found in her last CAT scan. Her doctor thought it could be due to her COVID vaccine but she is not sure since she got the vaccine back in Mar2021. The action taken in response to the event for crizotinib was unknown. Outcome of the event was unknown.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis flare/covid booster seemed to send into flare; Booster; This is a solicited report from a contactable consumer (patient) based on information received by Pfizer.   A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 3 intramuscular in 2021 (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation at the age of 57-year-old; adalimumab (HUMIRA, 40MG/0.4ML, Solution for injection in pre-filled pen), via subcutaneous from Jan2021 (Batch/Lot number was not reported) to an unspecified date, at 40 mg (40 mg,1 in 14 D) for rheumatoid arthritis.  The patient medical history was not reported. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. Concomitant medications included hydroxychloroquine sulfate; venlafaxine hydrochloride (EFFEXOR SR); metoprolol tartrate; vitamin d3; metformin hcl; levothyroxine sodium (SYNTHROID); Olmesartan Medoxomil (BENICAR); acetylsalicylic acid (ASPIRIN COX); ezetimibe (ZETIA); eicosapentaenoic acid ethyl ester (VASCEPA). She previously received first dose and second dose COVID-19 Vaccine manufactured by Pfizer (BNT162B2), via intramuscular for covid-19 immunisation in 2021. She received booster dose COVID-19 vaccine manufactured by Pfizer. In Oct2021, the patient experienced rheumatoid arthritis flare/covid booster seemed to send into flare. The action taken in response to the events for adalimumab was unknown. In Oct2021, the rheumatoid arthritis flare/covid booster seemed to send into flare resolved.  The reporter's assessment of the causal relationship of the events with the bnt162b2 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.  Causality for adalimumab: The reporter's causality for the event of rheumatoid arthritis flare/covid booster seemed to send into flare was probable.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Rheumatoid arthritis and BNT162B2.  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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cardiac discomfort, Chest pain, Differential white blood cell count, Full blood count
Clinical narrative: like having a heart attack; my throat was numb.; It was extreme like after the reflex like pain in my chest; I was having Heart pressure and my heart and my jaw and my throat was numb.; anxiety; my jaw was numb; Booster; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received third dose of bnt162b2 (Batch/Lot Number: FF2587, Expiration date: Unknown, age at the time of vaccination: 71-year-old) via an unspecified route of administration, administered in left upper arm on an unspecified date as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included cancer (have cancer two years ago) and high blood pressure; both from an unknown date and unknown if ongoing. Concomitant medications included letrozole taken for cancer (A chemo pill, To prevent the cancer from coming back), start and stop date were not reported; lisinopril taken for high blood pressure, start and stop date were not reported. The patient previously received bnt162b2 (Batch/Lot Number: EN5318), via an unspecified route of administration, administered in left upper arm on 08Feb2021 (age at vaccination was 70 years) as DOSE 1, SINGLE and bnt162b2 (Batch/Lot Number: EN6198), via an unspecified route of administration, administered in left upper arm on 01Mar2021 (age at vaccination was 71 years) as DOSE 2, SINGLE for covid-19 immunization and experienced like having a heart attack, my throat was numb, It was extreme like after the reflex like pain in my chest, I was having Heart pressure and my heart and my jaw and my throat was numb, my jaw was numb, anxiety. The patient reported that she had adverse reaction Pfizer her second vaccination and exactly the same reaction to the booster. On an unspecified date, the patient received booster dose and the patient was having heart pressure and her heart and jaw and throat was numb. She stated that it was extreme like after the reflex like pain in her chest and numbing in her throat and in her jaw like having a heart attack. When asked about the corrective therapy, the patient reported that she just gave three medication that she was on, because of her cancer. She take Cannabis Mint and anti anxiety at night, a pill, So when she had those adverse effect because at that she was having Heart pressure and her heart and her jaw and her throat was numb so she took a CBD to relax her body to the anxiety after almost a hour it come down. She took Xanax and CBD Mint 2.5 milligram. Petra Kiera Concession Cannabis infused Mint and she have one more pill the anti anxiety pill was Xanax and its 0.5 milligram and alprazolam. The patient underwent lab tests and procedures which included comprehensive metabolic panel, CBC and another differential, Cancer antigen with unknown results on 26Oct2021. Therapeutic measures were taken as a result of the events. Investigation assessment was reported. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Immunisation, Investigation, Metabolic function test, Myocardial infarction
Clinical narrative: like having a heart attack; my throat was numb.; It was extreme like after the reflex like pain in my chest; I was having Heart pressure and my heart and my jaw and my throat was numb.; anxiety; my jaw was numb; Booster; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received third dose of bnt162b2 (Batch/Lot Number: FF2587, Expiration date: Unknown, age at the time of vaccination: 71-year-old) via an unspecified route of administration, administered in left upper arm on an unspecified date as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included cancer (have cancer two years ago) and high blood pressure; both from an unknown date and unknown if ongoing. Concomitant medications included letrozole taken for cancer (A chemo pill, To prevent the cancer from coming back), start and stop date were not reported; lisinopril taken for high blood pressure, start and stop date were not reported. The patient previously received bnt162b2 (Batch/Lot Number: EN5318), via an unspecified route of administration, administered in left upper arm on 08Feb2021 (age at vaccination was 70 years) as DOSE 1, SINGLE and bnt162b2 (Batch/Lot Number: EN6198), via an unspecified route of administration, administered in left upper arm on 01Mar2021 (age at vaccination was 71 years) as DOSE 2, SINGLE for covid-19 immunization and experienced like having a heart attack, my throat was numb, It was extreme like after the reflex like pain in my chest, I was having Heart pressure and my heart and my jaw and my throat was numb, my jaw was numb, anxiety. The patient reported that she had adverse reaction Pfizer her second vaccination and exactly the same reaction to the booster. On an unspecified date, the patient received booster dose and the patient was having heart pressure and her heart and jaw and throat was numb. She stated that it was extreme like after the reflex like pain in her chest and numbing in her throat and in her jaw like having a heart attack. When asked about the corrective therapy, the patient reported that she just gave three medication that she was on, because of her cancer. She take Cannabis Mint and anti anxiety at night, a pill, So when she had those adverse effect because at that she was having Heart pressure and her heart and her jaw and her throat was numb so she took a CBD to relax her body to the anxiety after almost a hour it come down. She took Xanax and CBD Mint 2.5 milligram. Petra Kiera Concession Cannabis infused Mint and she have one more pill the anti anxiety pill was Xanax and its 0.5 milligram and alprazolam. The patient underwent lab tests and procedures which included comprehensive metabolic panel, CBC and another differential, Cancer antigen with unknown results on 26Oct2021. Therapeutic measures were taken as a result of the events. Investigation assessment was reported. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.