chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Inflammation, Joint swelling, Lymphoedema
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program Pfizer RxPathways via a contactable consumer reported for herself. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) at the age of 56-year-old, as single dose for covid-19 immunization. Medical history included back surgeries, reported she had a history of back surgeries in the past all of which she recovered well from and mild osteoarthritis in the past. The patient's concomitant medications were not reported. The patient received the historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date for Covid-19 immunization. On an unspecified date in 2021, she seemed to be having an ongoing reaction to the vaccine resulting in edema, parasthesia and severe joint pain. She was concerned at this point and would like to know how long it can take for the inflammation in her body to subside. She was extremely healthy and fit and have never experienced anything like this. Caller was calling about the covid vaccine. She was having long term reactions. She had seen several doctors, internist, vascular doctor, neurologist, and orthopedist. Her symptoms were severe joint swelling and pain in her knees and thumbs, she had mild osteoarthritis, paresthesia, neuropathy and severe edema. She is an armature athlete. She was scared because her symptoms were not going away. She wanted to do more than reporting bad side effects she would like to speak to someone to see if there are any other people reporting this. Within a couple weeks began to experience the following symptoms: severe inflammation and joint pain, pain in knees and thumbs, mild osteoarthritis in the past that was now severely inflamed, paresthesia described as pins and needles, neuropathy in the hands and feet falling asleep, burning sensation, severe edema, and lymphedema in the legs. Caller reported she was still experiencing the pain right now and it felt like her knee and thumb joints are on fire. Caller had sought medical care from the orthopedic, vascular, and neurologist. They had checked for DVT and autoimmune diseases. Caller was seeking information if other patients have reported these long lasting symptoms. The outcome of the event severe edema, paresthesia described as pins and needles, severe joint pain was not recovered. The outcome of the other events was unknown. Information on the batch/lot number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Neuropathy peripheral, Oedema, Osteoarthritis, Pain in extremity
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program Pfizer RxPathways via a contactable consumer reported for herself. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) at the age of 56-year-old, as single dose for covid-19 immunization. Medical history included back surgeries, reported she had a history of back surgeries in the past all of which she recovered well from and mild osteoarthritis in the past. The patient's concomitant medications were not reported. The patient received the historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date for Covid-19 immunization. On an unspecified date in 2021, she seemed to be having an ongoing reaction to the vaccine resulting in edema, parasthesia and severe joint pain. She was concerned at this point and would like to know how long it can take for the inflammation in her body to subside. She was extremely healthy and fit and have never experienced anything like this. Caller was calling about the covid vaccine. She was having long term reactions. She had seen several doctors, internist, vascular doctor, neurologist, and orthopedist. Her symptoms were severe joint swelling and pain in her knees and thumbs, she had mild osteoarthritis, paresthesia, neuropathy and severe edema. She is an armature athlete. She was scared because her symptoms were not going away. She wanted to do more than reporting bad side effects she would like to speak to someone to see if there are any other people reporting this. Within a couple weeks began to experience the following symptoms: severe inflammation and joint pain, pain in knees and thumbs, mild osteoarthritis in the past that was now severely inflamed, paresthesia described as pins and needles, neuropathy in the hands and feet falling asleep, burning sensation, severe edema, and lymphedema in the legs. Caller reported she was still experiencing the pain right now and it felt like her knee and thumb joints are on fire. Caller had sought medical care from the orthopedic, vascular, and neurologist. They had checked for DVT and autoimmune diseases. Caller was seeking information if other patients have reported these long lasting symptoms. The outcome of the event severe edema, paresthesia described as pins and needles, severe joint pain was not recovered. The outcome of the other events was unknown. Information on the batch/lot number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program Pfizer RxPathways via a contactable consumer reported for herself. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) at the age of 56-year-old, as single dose for covid-19 immunization. Medical history included back surgeries, reported she had a history of back surgeries in the past all of which she recovered well from and mild osteoarthritis in the past. The patient's concomitant medications were not reported. The patient received the historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date for Covid-19 immunization. On an unspecified date in 2021, she seemed to be having an ongoing reaction to the vaccine resulting in edema, parasthesia and severe joint pain. She was concerned at this point and would like to know how long it can take for the inflammation in her body to subside. She was extremely healthy and fit and have never experienced anything like this. Caller was calling about the covid vaccine. She was having long term reactions. She had seen several doctors, internist, vascular doctor, neurologist, and orthopedist. Her symptoms were severe joint swelling and pain in her knees and thumbs, she had mild osteoarthritis, paresthesia, neuropathy and severe edema. She is an armature athlete. She was scared because her symptoms were not going away. She wanted to do more than reporting bad side effects she would like to speak to someone to see if there are any other people reporting this. Within a couple weeks began to experience the following symptoms: severe inflammation and joint pain, pain in knees and thumbs, mild osteoarthritis in the past that was now severely inflamed, paresthesia described as pins and needles, neuropathy in the hands and feet falling asleep, burning sensation, severe edema, and lymphedema in the legs. Caller reported she was still experiencing the pain right now and it felt like her knee and thumb joints are on fire. Caller had sought medical care from the orthopedic, vascular, and neurologist. They had checked for DVT and autoimmune diseases. Caller was seeking information if other patients have reported these long lasting symptoms. The outcome of the event severe edema, paresthesia described as pins and needles, severe joint pain was not recovered. The outcome of the other events was unknown. Information on the batch/lot number has been requested.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Epistaxis, Headache
Clinical narrative: Massive nose bleeds; Headache almost every day; This is a spontaneous report from a contactable consumer (mother reporting for son). A 14-year-old male received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EWO177) via an unspecified route of administration in left arm on 22Jun2021 as dose 2, single (at the age of 14-years-old) for COVID-19 immunization. Patient medical history included known allergies. The concomitant medications included cetirizine hydrochloride tablet (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose and frequency of 10 mg, 1 tablet as needed for allergies, vitamins NOS (FLINTSTONES) at a dose and frequency of 1x/day (2 gummies once a day). Mother stated he takes ZYRTEC the generic kind.  He had been taking it since he was six about, on and off with allergies. He started taking flintstone vitamins last year for health. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-EWO177) via an unspecified route of administration in right arm on 01Jun2021 as dose 1, single for COVID-19 immunization. Mother was calling about the Pfizer Covid-19 Vaccine and wanted to report a side-effect her son had after second dose. She added they just got back from doctor office. This all happened after the second vaccination, ever since he got the second one on 22Jun2021. He has had headache almost every day since then. He had massive nose bleeds this week on Tuesday and Wednesday. After the first vaccine he had a headache for a few days also but it was not bad at all.  After the second, it was constant. It did not last all day, it came and went. She was unable to answer if symptoms were still going on and stated they come and go. The nose bleeds he has not had any today so far. They took some blood they are checking, including his clotting platelets or whatever that is, and they are checking to see if he has been bit by a tick.  Just for precautionary reasons.  She does not know results yet as he just got the blood today and they just got back from the doctor. When the headaches got bad, he would take Tylenol the first few days and then he took Motrin. She corrected and stated he took Ibuprofen, not Motrin. The adverse events did not result in emergency room visit but resulted in physician office visit. The outcome of the events was unknown.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Emotional distress, Malaise, Weight decreased
Clinical narrative: He is currently 203 pounds; it is starting to work on him mentally; He has not felt well; His energy levels are terrible; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 50-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0180; Expiration Date: 30Sep2021, NDC: unknown) via an unspecified route of administration, administered in arm right on 07Jun2021 14:00 (at the age of 50-year-old) at dose 2, 0.3 ml single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0182; Expiration Date: 31Aug2021, NDC: Unknown) via an unspecified route of administration, administered in right upper arm on 07May2021 14:00 (at the age of 50-year-old) at dose 1, 0.3mL single for covid-19 immunisation. On an unspecified date the patient experienced he is currently 203 pounds, it is starting to work on him mentally and on 10Jun2021 he has not felt well, his energy levels are terrible. Patient is calling about the Pfizer covid vaccine. He received the second dose of the covid vaccine on the afternoon of 07Jun2021. He has not felt well since 10Jun2021. He is going to see a doctor on Tuesday. He has not seen his doctor recently because of covid. He had to find a new doctor. His energy levels are terrible. He wishes he did not take the covid vaccine. He drives for a living. He feels terrible. He did not get a fever. He has not felt this way in years. He is currently 203 pounds. He is normally 215 pounds. He has lost 12 pounds. He does not know how common this is. He really does not want to make conversation with people, because people will be scared to take the covid vaccine. He started to feel terrible three days after the covid vaccine, and it is starting to work on him mentally. This has been going on for a month now. His energy levels are terrible: Whenever he eats something, he feels a little better. He does not feel terrible whenever he wakes up. He goes through the stresses of the day and started to not feel well around noon. He will eat lunch and fell and little better. Then start to feel bad again, and then eat again and feel better. Indication: He lives with his elderly mother and has two older sisters. He has to be as healthy as possible to be around his 84-year-old mother. Outcome of the events he has not felt well, his energy levels are terrible was not resolved and he is currently 203 pounds, it is starting to work on him mentally was unknown.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal ulceration
Clinical narrative: Vaginal ulcers; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 25-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 06May2021 (at the age of 25-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Patient had no known allergies. The patient concomitant medication included ethinylestradiol, norethisterone acetate (MICROGESTIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four week. Patient was not diagnosed with COVID prior vaccination. Patient was not COVID tested post vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced vaginal ulcers on 08May2021. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received Valtrex as treatment medication for the event vaginal ulcers. Outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Pain in extremity
Clinical narrative: first injection - sore arm for few hrs, fatigued 2 days, felt cold (wore jacket).; first injection - sore arm for few hrs, fatigued 2 days, felt cold (wore jacket).; first injection - sore arm for few hrs, fatigued 2 days, felt cold (wore jacket).; This is a spontaneous report from a contactable other hcp (Nurse) (patient). A 57-year-old (non-pregnant) female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ELO140) via an unspecified route of administration, administered in arm right on 18Dec2020 10:00 (at the age of 57-year-old) at dose 1, single for covid-19 immunisation. Medical history included hypothyroidism, mild latex and mild food allergies associated with latex. Covid prior vaccination was unknown, covid tested post vaccination was no. Concomitant medications included thyroid (ARMOUR THYROID) taken for hypothyroidism; levothyroxine (LEVOTHYROXINE); ergocalciferol (VIT D); ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10 [ASCORBIC ACID; BETACAROTENE; CUPRIC OXIDE; MANGANESE SULFATE; SELENIUM; TOCOPHERYL ACETATE; UBIDECARENONE; ZINC OXIDE]); asa (ASA) at 81 mg, 1x/day, 350 mg, 2x/day. On an unspecified date in Dec 2020 the patient experienced first injection - sore arm for few hrs, fatigued 2 days, felt cold (wore jacket). Adverse event-(First injection-sore arm for few hrs, fatigued 2 days, felt cold(wore jacket).x2days (afebrile)). Second injection - very sore arm x 3days, 48 hr after injection developed PVC's - in/out of geminy for 3 days then geminy resolved but remained with what seemed like unifocal pvc's at first, which slowly progressed into more frequent and multifocal pvc's, worsening with any increased activity (ex: walking from parking lot to work place), generalized fatigue which worsened over time with worsening of pvc frequency. Lasted almost exactly 4 months from day of injection (15 weeks). Abt to request cardiology referral, increased ASA intake to 350 mg bid (was 81 mg qd) (self prescribed) and pvc's progressively resolved over 4-5 day period then stopped completely. Energy returned. Also, developed scalp pain (abt 10 resolved then returned), then developed Shingles-type nerve pain left trunk, and also 2x over that 4 mo had near-eruption of herpes in corner of mouth (in remission x40 yrs), adverse event start date-12Jan2021 adverse event start time-01:00 PM, (Lot number-EL3302, Lot unknown- False, administration date-10Jan2021, administration time-03:00 PM, dose number-2, vaccine location-Left arm). Patient did not receive treatment for the adverse events. Outcome of the events was resolved on an unspecified date.   Follow-Up (19Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Insomnia, Malaise, Night sweats
Clinical narrative: Flu-like symptoms; Low grade fever; Body aches; Night sweats; Shaking involuntary; Malaise; Could not sleep well those two nights; it still hurt when she touched it; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 03Feb2021 (Lot Number: EL8982) at the age of 70-year-old as singe dose for covid-19 immunisation.  The patient medical history was not reported. Concomitant medication included levothyroxine sodium. The patient previously took the dose 1 of bnt162b2 on 14Jan2021 for COVID-19 immunization and experienced pain on her arm on 15Jan2021, rash on 15Jan2021, red spot where she had the vaccine and it was itchy on 15Jan2021, a little bit of a bump and it still hurts and when she touch it. In 2021, the patient experienced flu-like symptoms, low grade fever, body aches, night sweats, shaking involuntary, malaise, could not sleep well those two nights, it still hurt when she touched it. Therapeutic measures were taken as a result of it still hurt when she touched it. Outcome of events was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tremor, Vaccination site pain
Clinical narrative: Flu-like symptoms; Low grade fever; Body aches; Night sweats; Shaking involuntary; Malaise; Could not sleep well those two nights; it still hurt when she touched it; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 03Feb2021 (Lot Number: EL8982) at the age of 70-year-old as singe dose for covid-19 immunisation.  The patient medical history was not reported. Concomitant medication included levothyroxine sodium. The patient previously took the dose 1 of bnt162b2 on 14Jan2021 for COVID-19 immunization and experienced pain on her arm on 15Jan2021, rash on 15Jan2021, red spot where she had the vaccine and it was itchy on 15Jan2021, a little bit of a bump and it still hurts and when she touch it. In 2021, the patient experienced flu-like symptoms, low grade fever, body aches, night sweats, shaking involuntary, malaise, could not sleep well those two nights, it still hurt when she touched it. Therapeutic measures were taken as a result of it still hurt when she touched it. Outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pain in extremity, Skin mass
Clinical narrative: soreness of the muscles in her arm; going towards her chest area; on the right side of her jaw she noticed a bump that looks like it has blood in it; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at dose number unknown, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced soreness of the muscles in her arm going towards her chest area, on the right side of her jaw she noticed a bump that looks like it has blood in it. Patient is calling about the Pfizer COVID-19 vaccine. She wants to know if the side effects of soreness of the muscles in her arm going towards her chest area and on the right side of her jaw she noticed a bump that looks like it has blood in it and she just wants to make sure that is from the vaccine. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity, Tenderness
Clinical narrative: had the Pfizer Vaccine on 22Mar2021 and had the 2nd dose of the vaccine today; a little soreness in the arm from getting the shot; Hers is just a little tender; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0185), via an unspecified route of administration in the left arm on 09Jul2021 at 12:15 (at the age of 50-year-old) as dose 2, 0.3 ml single for COVID-19 immunisation in pharmacy. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6198), via an unspecified route of administration in the left arm on 22Mar2021 (at the age of 50-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that she was called about the Pfizer Vaccination and stated she and her husband both had the Pfizer Vaccine on 22Mar2021 and then had hesitancy about getting the 2nd dose of the vaccine but both she and her husband did get the 2nd doses of their vaccines today at "PRIVACY"; she had some question about the amount of time between the two doses of the Pfizer Vaccines for herself and for her husband about whether or not they were within the amount of time Pfizer recommends and to they need to start over with the 2nd shots being their 1st shots. Caller said that she was having a little soreness in the arm from getting the shot. She said that her husband does not even have that. She was just a little tender. She wanted to know "Has Pfizer provided a statement on the need for a booster dose (3rd dose) and Is Pfizer investigating the need for a booster dose. Response: As part of Pfizer's and BioNTech's continued efforts to stay ahead of the virus causing COVID-19 and circulating mutations, the companies provided an update on booster dosing on 09Jul2021. Please note that the use of a 3rd or booster dose is not recommended or authorized, and Pfizer does not suggest the use of the vaccine in any manner other than as described in the authorized EUA Prescribing Information authorized product monograph. Initial data from the ongoing study of booster doses demonstrated a consistent tolerability profile and high neutralization titers against the wild-type virus (the naturally occurring non-mutated virus) and the Beta variant. It was thought that the effects seen against the Beta variant may also be seen in the Delta variant. We are doing studies to confirm this. We expect to publish the data soon in a peer-reviewed journal and submit to regulatory authorities like the FDA in the coming weeks. The adverse events did not result in visit to emergency room and physician office. The outcome of the events was not resolved.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021868964 Same product and event, different patients
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: 7 hours later developed a rash, like hives; 7 hours later developed a rash, like hives; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a female patient (reporter's aunt). A 68-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry Date was unknown), via an unspecified route of administration on an unspecified date (at the age of 68-year-old) at dose 1, single for covid-19 immunisation. Medical history included allergic to peanuts and cashews. Concomitant medications were not reported. On an unspecified date the patient experienced 7 hours later developed a rash, like hives. The reporter stated that his aunt got vaccinated a week and a half or two weeks ago with the first dose of the vaccine and 7 hours later developed a rash, like hives. He asked if she should receive the second dose. The reporter asked if there are any issues with getting the vaccine with nut allergies. The reporter asked if the base of the vaccine is the same as the flu vaccine. Explained that Pfizer Medical Information is unable to compare the ingredients with other products. Offered to send the list of ingredients but the reporter declined. The reporter asked what the main base of the vaccine is, offered to send the list of ingredients but the reporter declined. Reporter stated, So I wanted to check about a reaction, my aunt got the COVID vaccination about a week ago, the first shot. About 7 hours later she had a rash, like hives. She slept through the night and it went away but I was wondering if she could get the second shot because of that. Reporter stated she is calling for his aunt. She got the vaccine about a week and a half ago to maybe 2 weeks ago. When she got the vaccine, the first shot, 7 hours later she developed a rash, like hives essentially. He was wondering if he should recommend she gets the second shot. The patient obtained a rash seven hours after receiving the vaccine and it cleared on it's own within six hours. Outcome of the events was resolved on an unspecified date.   Information about lot/batch number has been requested.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This is a spontaneous report from a contactable Nurse reported for (patient). A 13-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 07Jul2021(age at vaccination 13 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient visited emergency room for reported events. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced anaphylaxis on 07Jul2021. The outcome of event was unknown.  Information about lot/batch number is requested.; Sender's Comments: There is a reasonable possibility that the event Anaphylactic Reaction was related to the use if suspect product BNT162b2 based on known drug safety profile and the close temporal relationship.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Inappropriate schedule of product administration, Menstruation irregular
Clinical narrative: Since having the vaccine have been experiencing very irregular, heavy, and excessively long menstruation.; Since having the vaccine have been experiencing very irregular, heavy, and excessively long menstruation.; Administration date 07Apr2021, dose number 2, Administration date 21Apr2021, dose number 1; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 22-years-old non-pregnant female patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: ENG6199), via an unspecified route of administration, administered in Arm Left on 07Apr2021 at 15:00 (at the age of 22-years-old) as dose 1, single and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EP7534), via an unspecified route of administration, administered in Arm Left on 21Apr2021 at 15:00 (at the age of 22-years-old) as dose 2, Single for COVID-19 immunization. The patient's medical history included major depression, anxiety disorder (Verbatim: General anxiety disorder), endometriosis from an unknown date and unknown if ongoing. Concomitant medications included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. Patient had no know allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnose with COVID-19. Since the vaccination, patient did not been tested for COVID-19. Since having the vaccine, the patient has been experiencing very irregular, heavy, and excessively long menstruation on 11Apr2021. Facility where the most recent COVID-19 vaccine was administered: Hospital. Outcome of events at the time of last observation was recovered/recovered with sequel and for inappropriate schedule of vaccine administered was Unknown.  Information related to batch/Lot no. was requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Intraocular pressure increased
Clinical narrative: Dramatic increase in ocular eye pressure causing loss of vision.; Dramatic increase in ocular eye pressure causing loss of vision.; This is a spontaneous report from a contactable consumer (reporter himself). A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 18Apr2021 15:00 (age at vaccination 74-year-old) as dose1, single for covid-19 immunisation. Medical history included glaucoma. The patient's concomitant medication included eye drops for glaucoma received within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient had no known allergies. Patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced dramatic increase in ocular eye pressure causing loss of vision on 21Apr2021 09:00. The patient lab test included intraocular pressure increased (dramatic increase in ocular eye pressure) on 21Apr2021. The event resulted in the doctor or other healthcare professional office/clinic visit. The patient received treatment for the events was new stronger ophthalmic drops. Since the vaccination, the patient had not tested for COVID-19. The outcome of the events was not resolved.   Follow-up attempts are needed. Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Chills, Ear infection bacterial, Ear pain, Ear swelling
Clinical narrative: Ear Drainage, swollen ear, crusted blisters, continued extreme ear pain and down through neck on right side; Diagnosed Shingles in ear and super bacterial infection in ear; Ear Drainage, swollen ear, crusted blisters, continued extreme ear pain and down through neck on right side; Ear Drainage, swollen ear, crusted blisters, continued extreme ear pain and down through neck on right side; Extreme ear pain and down through neck on right side; Diagnosed Shingles in ear and super bacterial infection in ear; Fever; Chills; Exhaustion; Vertigo; This is a spontaneous report from a contactable consumer or other non-healthcare professional.   A 48-years-old non-pregnant female patient (non-pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 14Apr2021 (Batch/Lot Number: ER8731, Expiry date was not reported) (at the age of 48-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was reported as none. There were no known allergies reported. Concomitant medications included vitamins. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8730, Expiry date was not reported), via an unspecified route of administration, administered in Left arm on 23Mar2021 (48-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 15Apr2021, the patient experienced chills, fever, exhaustion, Extreme ear pain and down through neck on right side, Ear Drainage, swollen ear, crusted blisters, continued extreme ear pain and down through neck on right side, Vertigo, diagnosed Shingles in ear and super bacterial infection in ear and vertigo. It was reported as within 12 hours, the patient had chills, fever and exhaustion, on day 3- Extreme ear pain and down through neck on right side, on day 4-7- Ear Drainage, swollen ear, crusted blisters, continued extreme ear pain and down through neck on right side and on day 8-Vertigo and diagnosed Shingles in ear and super bacterial infection in ear. The events resulted doctor or other healthcare professional office/clinic visit. Treatment included antibiotics, ear drops, nausea and dizziness medicine. The clinical outcome of the events was reported as recovered on an unspecified date in Apr2021.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Herpes zoster, Otorrhoea, Pyrexia, Vertigo
Clinical narrative: Ear Drainage, swollen ear, crusted blisters, continued extreme ear pain and down through neck on right side; Diagnosed Shingles in ear and super bacterial infection in ear; Ear Drainage, swollen ear, crusted blisters, continued extreme ear pain and down through neck on right side; Ear Drainage, swollen ear, crusted blisters, continued extreme ear pain and down through neck on right side; Extreme ear pain and down through neck on right side; Diagnosed Shingles in ear and super bacterial infection in ear; Fever; Chills; Exhaustion; Vertigo; This is a spontaneous report from a contactable consumer or other non-healthcare professional.   A 48-years-old non-pregnant female patient (non-pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 14Apr2021 (Batch/Lot Number: ER8731, Expiry date was not reported) (at the age of 48-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was reported as none. There were no known allergies reported. Concomitant medications included vitamins. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8730, Expiry date was not reported), via an unspecified route of administration, administered in Left arm on 23Mar2021 (48-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 15Apr2021, the patient experienced chills, fever, exhaustion, Extreme ear pain and down through neck on right side, Ear Drainage, swollen ear, crusted blisters, continued extreme ear pain and down through neck on right side, Vertigo, diagnosed Shingles in ear and super bacterial infection in ear and vertigo. It was reported as within 12 hours, the patient had chills, fever and exhaustion, on day 3- Extreme ear pain and down through neck on right side, on day 4-7- Ear Drainage, swollen ear, crusted blisters, continued extreme ear pain and down through neck on right side and on day 8-Vertigo and diagnosed Shingles in ear and super bacterial infection in ear. The events resulted doctor or other healthcare professional office/clinic visit. Treatment included antibiotics, ear drops, nausea and dizziness medicine. The clinical outcome of the events was reported as recovered on an unspecified date in Apr2021.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypokinesia, Limb injury
Clinical narrative: unable to lift arm for several hours; SEVERE shoulder pain; decreased range of motion which has persisted for 3 months now; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: ER8733), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 at 13:15 (at the age of 59 years) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included acetylsalicylic acid (BABY ASPIRIN); vitamin d nos (VITAMIN D NOS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 01Apr2021 at 07:00, Patient reported within 24 hours, unable to lift arm for several hours, followed by severe shoulder pain and decreased range of motion which has persisted for 3 months now. Patient received Physical therapy as a treatment for events. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of events was not recovered.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer (reported for herself). A 58-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0177), dose 2 via an unspecified route of administration, administered in arm left on 19Apr2021 at 17:00 (at the age of 58-years-old) as dose 2, single for covid-19 immunization at Pharmacy or Drug Store. Medical history included ongoing blood cholesterol and ongoing nephropathy. The patient did not receive any other vaccines within four weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Device Date was reported as 11Jul2021.Concomitant medication within 2 weeks of vaccination included rosuvastatin (ROSUVASTATIN). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0162), dose 1 via an unspecified route of administration, administered in arm left on 19Apr2021 at 17:00 (at the age of 58-years-old) as dose 1, single for covid-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. On 05Jul2021 at 09:00, the patient experienced bell's palsy. The case assessed as serious (Disabling/Incapacitating, medically significant). There was no Prolonged hospitalization. The adverse event result in Emergency room/department or urgent care. Therapeutic measures were taken as a result of event and treatment included with Prednisone, Valacyclovir and Systane. The outcome of the event was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Paranasal sinus discomfort, SARS-CoV-2 test, Vertigo
Clinical narrative: pressure in sinus cavity which lead to extreme vertigo and nausea; pressure in sinus cavity which lead to extreme vertigo and nausea; pressure in sinus cavity which lead to extreme vertigo and nausea; This is a spontaneous report received from a contactable consumer (the patient). A 53-year-old male patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number- EW0170, expiration date was unknown) via an unspecified route of administration in left arm on an unspecified date (at the age of 53-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No known allergies. The patient previously received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6208, expiration date was unknown) via an unspecified route of administration in left arm on 17Mar2020 11:00 (at the age of 53-year-old) as dose 1, single for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications the patient received within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination. On 24Apr2021 at 02:00, next day after vaccination, patient experienced pressure in sinus cavity which lead to extreme vertigo and nausea. Patient was hospitalized for 2 days. Events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. Patient underwent lab tests and procedure which included SARS-CoV-2 test nasal swab and result was negative on 26Apr2021. Patient was tested for COVID-19 since the vaccination. Patient received Meclazine treatment for the events. Outcome of the events was recovered (resolved with sequel) on unknown date in 2021.   Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Circumstance or information capable of leading to medication error, Feeling abnormal, Feeling of body temperature change, Gait disturbance
Clinical narrative: I broke out with a rash; I felt caught in cold; feet got extremely numb and tingly; feet got extremely numb and tingly; felt like hot and cold on my feet, it felt like cold water going through; I had trouble walking; I felt really strange/ i am not feeling the greatest; Chills; I am not going to get the second shot; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported; Expiration Date: 05Aug2021; NDC number and UPC number: unknown) via an unspecified route of administration on 02Jul2021 (at the age of 63-years-old) in right arm as a single dose for covid-19 immunization. Medical history included autoimmune disorder from an unknown date and unknown if ongoing. The patient takes a lot of unspecified medication. The report was not related to a study or programme. Patient got the shot a week ago and right away shortly she got a reaction. She felt that she caught in cold, felt really strange. They checked her for an hour. When she was walking to car her feet got extremely numb and tingly then she felt like hot and cold on her feet, like cold water going through and then she had trouble walking because of it. She went to the emergency room and then they said its part of the shot. She had not felt like ever since. She experienced chills and broke out with a rash; she was not feeling the greatest and she was not a happy champer. She reported that she will not take the second shot. The patient was treated with antihistamine like Claritin. The outcome of all the events was unknown.  Information about lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nasopharyngitis, Paraesthesia, Rash
Clinical narrative: I broke out with a rash; I felt caught in cold; feet got extremely numb and tingly; feet got extremely numb and tingly; felt like hot and cold on my feet, it felt like cold water going through; I had trouble walking; I felt really strange/ i am not feeling the greatest; Chills; I am not going to get the second shot; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported; Expiration Date: 05Aug2021; NDC number and UPC number: unknown) via an unspecified route of administration on 02Jul2021 (at the age of 63-years-old) in right arm as a single dose for covid-19 immunization. Medical history included autoimmune disorder from an unknown date and unknown if ongoing. The patient takes a lot of unspecified medication. The report was not related to a study or programme. Patient got the shot a week ago and right away shortly she got a reaction. She felt that she caught in cold, felt really strange. They checked her for an hour. When she was walking to car her feet got extremely numb and tingly then she felt like hot and cold on her feet, like cold water going through and then she had trouble walking because of it. She went to the emergency room and then they said its part of the shot. She had not felt like ever since. She experienced chills and broke out with a rash; she was not feeling the greatest and she was not a happy champer. She reported that she will not take the second shot. The patient was treated with antihistamine like Claritin. The outcome of all the events was unknown.  Information about lot/batch number has been requested.