chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Limb discomfort, Neck pain, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0217), via an unspecified route on 13Jun2021 (at the age of 67-years) as 1st dose, single dose in the left arm for COVID-19 immunization. The patient medical history included fibromyalgia, chronic fatigue syndrome, irritable bowel syndrome, gastroparesis, diverticulitis, depression, anxiety, migraine, headache. Concomitant medications included Bupropion, Gabapentin, Nortriptyline, Quetiapine, angelica sinensis root, cimicifuga racemosa root, dioscorea spp., glycine max (PHYTOESTROGEN). The patient previously took flu shot last year. In Jun2021, the patient experienced soreness in the arm. He got vaccine in left arm and having pain in his right arm and his right toes, then his right foot the big toe was giving him some weird sensations, the small toes. It was just a weird sensation like tingling and also having a headache in the back on my head and neck. He had fibromyalgia, he knows how that pain feels like, but this was a different kind of pain. He had pain like headache on the back of my head and my neck and like just some soreness that could be considered medicinal like he had fibromyalgia and chronic fatigue, so he know the difference in what he fell from the fibromyalgia and when it is something different and then on my right arm, he got the shot in my left arm the pharmacist said it was better to get it on the non-dominant arm in case you have a problem and he understand that he could get the fatigue but he had just kind of concern about other stuff, neck pain and headache and having symptoms that are just different from my regular fibromyalgia and also that right foot. He took Tylenol for pain, but that was years ago. The events were still persisting that means still going on. The outcome of the events was not recovered.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0217), via an unspecified route on 13Jun2021 (at the age of 67-years) as 1st dose, single dose in the left arm for COVID-19 immunization. The patient medical history included fibromyalgia, chronic fatigue syndrome, irritable bowel syndrome, gastroparesis, diverticulitis, depression, anxiety, migraine, headache. Concomitant medications included Bupropion, Gabapentin, Nortriptyline, Quetiapine, angelica sinensis root, cimicifuga racemosa root, dioscorea spp., glycine max (PHYTOESTROGEN). The patient previously took flu shot last year. In Jun2021, the patient experienced soreness in the arm. He got vaccine in left arm and having pain in his right arm and his right toes, then his right foot the big toe was giving him some weird sensations, the small toes. It was just a weird sensation like tingling and also having a headache in the back on my head and neck. He had fibromyalgia, he knows how that pain feels like, but this was a different kind of pain. He had pain like headache on the back of my head and my neck and like just some soreness that could be considered medicinal like he had fibromyalgia and chronic fatigue, so he know the difference in what he fell from the fibromyalgia and when it is something different and then on my right arm, he got the shot in my left arm the pharmacist said it was better to get it on the non-dominant arm in case you have a problem and he understand that he could get the fatigue but he had just kind of concern about other stuff, neck pain and headache and having symptoms that are just different from my regular fibromyalgia and also that right foot. He took Tylenol for pain, but that was years ago. The events were still persisting that means still going on. The outcome of the events was not recovered.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: still feeling sick; This is a spontaneous report from a contactable consumer or other non hcp. A 16-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number and Expiration Date was not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Reporter stated he received his second dose of Pfizer COVID vaccine 2 weeks ago and still feeling sick from it. He did not know if it was supposed to be like that and wanted to know if that was normal. The outcome of event was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Menstrual cycle irregularities after the second vaccine dose; This is a spontaneous report from a contactable consumer (patient) via company representative. A patient of unspecified age and gender received second dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included tozinameran taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection), first dose via on an unspecified date as single dose for covid-19 immunisation and no reaction on previous exposure to drug. On an unspecified date, the patient experienced menstrual cycle irregularities after the second vaccine dose. The outcome of the event was unknown.  Information on Lot/Batch information has been requested. .
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Chest pain, Circumstance or information capable of leading to medication error, Electrocardiogram
Clinical narrative: chest pains; heavy feeling on his chest; anxiety; The physician doesn't feel that the patient should get the second shot; This is spontaneous report from contactable consumer (patient's friend). A Nearly 20-year-old male patient of unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: Unknown) via unspecified route of administration, on an unknown date, as a 1st dose, single for COVID-19 Immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient felt upset and experienced chest pain, it was some kind of like heavy feeling on his chest. The nurse called it anxiety which was wrong and should have notified by the physician. After a few days, on an unknown date it went away on its own however the patient wanted to receive the second shot. It was reported that the reporter told to the patient to inform the doctor and do not take anything until speak to physician. On an unknown date, the physician said he needs an electrocardiogram (EKG) and may not be able to take the shot. The Patient underwent EKG and the results were fine. However, the patient was supposed to go back in a week. The physician also said if there was a slight problem, to call and will see the patient immediately. The physician also mentioned that there was a special meeting on with the doctors and pharmacy people, since 200 patients have been affected by this and 2% have been landed in the hospital with serious conditions. The physician doesn't feel that the patient should get the second shot. The patient also stated that he thought the Pfizer shot was the better shot. However, it may not be good for the younger people. The patient would like to reach out to him on this and wanted to know what was going on and what was this meeting supposed to accomplish and where was it being held and it should go on the news. The outcome of the events chest pain and Circumstance or information capable of leading to medication error was unknown. On an unknown date, the events anxiety and chest discomfort were recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Numbness in her arm that has progressed to her shoulder, elbow, and now in her jaw; Numbness in her arm that has progressed to her shoulder, elbow, and now in her jaw; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 28May2021 as 1st dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 28May2021, patient experienced numbness in her upper arm that had progressed, it started in her shoulder and down to her elbow and the part of her jawline just started recently the rest of it had been from the beginning. Patient stated her concern was that she was due to get the second dose on Friday and she wanted to make sure everything was okay to take it and what she was having was typical. Patient was advised to follow up with primary care physician or local health care department for treatment recommendations and medical advice. The outcome of the events was unknown.   Information about batch/ lot number has been requested
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Headache, Laboratory test, Oropharyngeal pain, Pain in extremity
Clinical narrative: Fever; Headache; A lot of pain in throat; Couldn't swallow; arm was hurting; This is a spontaneous report received from a contactable consumer (mother). A 15-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0168), via an unspecified route of administration, administered in arm (Unknown if right or left, but thinks right) on 24May2021 (age at vaccination: 15 years) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On an unknown date in May2021 (was unsure of date, either 25May2021 or 26May2021), the patient experienced arm was hurting from the second day; on 13Jun2021 16:00, fever, headache, a lot of pain in throat and couldn't swallow. As the patient got sick and due to fever, she was sent to emergency room yesterday and they sent her home. The patient was due for second dose on an unknown date (reported as Monday, yesterday). She couldn't receive the second dose because she was sick, so she took her to the doctor yesterday because from Sunday she had a fever and Monday still having the fever so yesterday in the middle of the day, she took her to the doctor. She wasn't having symptoms from first dose, just arm was hurting, no fever or nothing else. She did not have fever after first dose until 13Jun2021 Sunday. The patient did not require a physicians' office visit. On 14Jun2021, the patient underwent test for throat infection which was negative and gave no antibiotics. The patient received the following treatment for the adverse events: Tylenol and Motrin, dose unknown, 2 pills for sore arm. For the Fever, pain in throat, headache, trouble swallowing received Tylenol every 6 hours and her daughter was getting better, no fever and headache. For swallowing: gargling with hot water, lemon, and salt, and was getting better. She no longer has the sore arm she is better now. The outcome of the event oropharyngeal pain and dysphagia was recovering, and all the other events were recovered on an unknown date in 2021.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Headache; A lot of pain in throat; Couldn't swallow; arm was hurting; This is a spontaneous report received from a contactable consumer (mother). A 15-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0168), via an unspecified route of administration, administered in arm (Unknown if right or left, but thinks right) on 24May2021 (age at vaccination: 15 years) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On an unknown date in May2021 (was unsure of date, either 25May2021 or 26May2021), the patient experienced arm was hurting from the second day; on 13Jun2021 16:00, fever, headache, a lot of pain in throat and couldn't swallow. As the patient got sick and due to fever, she was sent to emergency room yesterday and they sent her home. The patient was due for second dose on an unknown date (reported as Monday, yesterday). She couldn't receive the second dose because she was sick, so she took her to the doctor yesterday because from Sunday she had a fever and Monday still having the fever so yesterday in the middle of the day, she took her to the doctor. She wasn't having symptoms from first dose, just arm was hurting, no fever or nothing else. She did not have fever after first dose until 13Jun2021 Sunday. The patient did not require a physicians' office visit. On 14Jun2021, the patient underwent test for throat infection which was negative and gave no antibiotics. The patient received the following treatment for the adverse events: Tylenol and Motrin, dose unknown, 2 pills for sore arm. For the Fever, pain in throat, headache, trouble swallowing received Tylenol every 6 hours and her daughter was getting better, no fever and headache. For swallowing: gargling with hot water, lemon, and salt, and was getting better. She no longer has the sore arm she is better now. The outcome of the event oropharyngeal pain and dysphagia was recovering, and all the other events were recovered on an unknown date in 2021.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Lymphadenopathy, Pain
Clinical narrative: Body was aching all over; developed a lump on his left armpit; it doesn't feel hard, but it is the size of an egg, and it hurts and bothers him; area does not feel hard, like a lymph node, rather it is soft; This is a spontaneous report from a contactable consumer or other non-health care professional (patient's fiance). A 53-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: EW0178; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in arm left (on right arm muscle and was placed too high, on his arm) on 12Jun2021 10:50 AM (at age of 53-year-old) at dose of 0.3 ml, as single dose for Covid-19 immunization. medical history included Smoker. Concomitant medications were not reported. Patient received previously first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: EW0187; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in arm left on 22May2021 10:30 AM (at age of 53-year-old), at dose of 0.3 ml, as single dose for Covid-19 immunization.The patient was not administered with additional vaccines on the same date of Pfizer Suspect. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The reporter stated that she asked the patient to take the vaccine and patient also felt he should get the vaccine, but at first, he was hesitant. The reporter reported that within a few days or so, on 12Jun2021 19:00, the patient developed a lump on his left armpit; it doesn't feel hard, but it is the size of an egg, and it hurts and bothers him (after second vaccine). The reporter concerned mostly, with the lump under armpit, which was turning into a blood clot. The patient thought that it was not placed correctly and might be for that reason he had these effects. area does not feel hard, like a lymph node, rather it is soft. On 13Feb2021, the patient's body was aching all over, after second vaccine. The patient received treatment with Tylenol every 6 hours for body pain, and stated it was effective as the patient felt better. The reporter stated that Pfizer was unable to provide medical advice but might have resources to help answer some questions and the reporter encouraged to seek medical attention. The outcome of the event body was aching all over was resolved on 14Jun2021, while the outcome of the other events was not resolved.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nasopharyngitis, Rhinorrhoea, Vaccination site pain
Clinical narrative: colds; runny nose; a little muscle pain at the injection site; mild muscle pain; This is a spontaneous report from a contactable consumer (patient's wife) from a Pfizer-sponsored program a 73-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0185 and Expiration date not reported) via an unspecified route of administration, administered in left arm on 26May2021 at 09:16 (at the age of 73-year-old) at a (0.3 dose, units not provided) single dose for COVID-19 immunization at Pharmacy/drug store. Patient was healthy when he took the first vaccination. The patient had no medical history and concomitant medication were not reported. The patient did not receive additional vaccines administered on same date of the vaccination and within four weeks prior to vaccination. The patient previously received vitamins including Vitamin C. On an unspecified date in May2021, after the vaccination, patient had colds and runny nose for a week, and still have a little cold, had just a little muscle pain at the injection site and mild muscle pain that went away the following day. Reporter stated that he got this virus or cold because of the weather. It's very hot right now and believe that was the reason why he had the colds. The patient received treatment with NyQuil, Dayquil, and Tylenol for the cold. Events were not resulted in emergency room or physician Office. The patient was scheduled for the second dose for the Pfizer COVID-19 vaccine tomorrow, 16Jun2021. So, he was afraid of the second dose since he was just getting over and still recuperating from the cold and won't know what the effect will be. The outcome of the events colds and runny nose was recovering, and the rest of the events was recovered on an unspecified date in May2021.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling abnormal, Headache, Myalgia
Clinical narrative: muscle pain; joint pain; puffy eyes; feels bad; bad headache; chills; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date in Jun2021 as 2nd dose, single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, fibromyalgia. The patient's concomitant medications were not reported. The patient previously took methotrexate for rheumatoid arthritis and experienced shingles. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unknown date as 1st dose, single dose for COVID-19 immunisation and experienced pain, was nauseated, and ended up vomiting. The patient reported that she has been a mess and had Rheumatoid Arthritis and Fibromyalgia. She ended up getting Shingles 3 months ago and stopped Methotrexate prior to getting vaccine. She has not started it back, so she was pretty inflamed with Rheumatoid. The patient stated prior to the first dose of the vaccine she had gotten shingles and stopped her methotrexate for rheumatoid arthritis and fibromyalgia. On an unspecified date in Jun2021, the patient had muscle pain, joint pain, and stuff and it took a day to hit her after second vaccination. The pxatient stated the symptoms were not that bad a day before (yesterday) and she was able to work. Sunday it was the same thing. Day before she still had muscle pain and joint pain, but it was not that bad, and she ended up working. "Last night" all of a sudden "bam" the pain intensified. "Today" (15Jun2021) patient woke up with puffy eyes, feels bad, and has a bad headache. Patient would like to know did Pfizer heard of it going in sections like that, where symptoms developed on the 5th or 6th day. In between she had chills. She would have a chill and then a couple of hours later another chill. The patient stated she was used to the muscle pain and joint pain due to her fibromyalgia and rheumatoid arthritis, but she was not expecting the symptoms to hit her like a ton of bricks. She just wanted to make sure it was normal for the side effects to appear after so long since she had received the vaccine. Patient informed she does not feel good at this time. The outcome of event feels bad was not resolved and rest all events was unknown.  Information about batch/lot number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Periorbital swelling
Clinical narrative: muscle pain; joint pain; puffy eyes; feels bad; bad headache; chills; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date in Jun2021 as 2nd dose, single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, fibromyalgia. The patient's concomitant medications were not reported. The patient previously took methotrexate for rheumatoid arthritis and experienced shingles. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unknown date as 1st dose, single dose for COVID-19 immunisation and experienced pain, was nauseated, and ended up vomiting. The patient reported that she has been a mess and had Rheumatoid Arthritis and Fibromyalgia. She ended up getting Shingles 3 months ago and stopped Methotrexate prior to getting vaccine. She has not started it back, so she was pretty inflamed with Rheumatoid. The patient stated prior to the first dose of the vaccine she had gotten shingles and stopped her methotrexate for rheumatoid arthritis and fibromyalgia. On an unspecified date in Jun2021, the patient had muscle pain, joint pain, and stuff and it took a day to hit her after second vaccination. The pxatient stated the symptoms were not that bad a day before (yesterday) and she was able to work. Sunday it was the same thing. Day before she still had muscle pain and joint pain, but it was not that bad, and she ended up working. "Last night" all of a sudden "bam" the pain intensified. "Today" (15Jun2021) patient woke up with puffy eyes, feels bad, and has a bad headache. Patient would like to know did Pfizer heard of it going in sections like that, where symptoms developed on the 5th or 6th day. In between she had chills. She would have a chill and then a couple of hours later another chill. The patient stated she was used to the muscle pain and joint pain due to her fibromyalgia and rheumatoid arthritis, but she was not expecting the symptoms to hit her like a ton of bricks. She just wanted to make sure it was normal for the side effects to appear after so long since she had received the vaccine. Patient informed she does not feel good at this time. The outcome of event feels bad was not resolved and rest all events was unknown.  Information about batch/lot number has been requested
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching; Had hives the same day as she had her vaccine; This is a spontaneous report received from a contactable consumer (Patient). A 22-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: EP7533, expiration date: Jul2021) via an unspecified route of administration, administered in arm left on 04Jun2021 at a dose of 0.3 ml as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had the Pfizer vaccine on 04Jun2021. She had hives the same day 04June2021. Since 04Jun2021, patient has had hives and itching. Patient was due for her second dose in one and a half weeks. She wanted to know if she should get her second dose. The outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: she felt some of those things, specifically her feet; This is a spontaneous report from a contactable consumer. This consumer reported for a female nurse practitioner (patient) that a female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the Nurse Practitioner took the covid vaccine and the nurse practitioner said she felt some of those things, specifically her feet. The outcome of the event was unknown.   Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Joint stiffness, Joint swelling, Mobility decreased, Pain in extremity
Clinical narrative: Restricted mobility in my leg; My knees weren't bending fully; I feel a visible pain in my ankle and my finger; I feel a visible pain in my ankle and my finger; I have visible swelling in my chin and my ankle and possibly my thighs; I have visible swelling in my chin and my ankle and possibly my thighs; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Jun2021 as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (Lot: unknown) on unknown date via an unspecified route of administration for COVID-19 immunisation. On 16Jun2021, patient got the second vaccine at about 04:30 eastern about 9 or 10 hours ago and after 6 hours after getting the vaccine or 5 hours (as reported) after the vaccine the second shot, felt a little bit restricted mobility in leg and knees weren't bending fully and right now 12 hours after the second dose and felt a visible pain in ankle and finger it did not hurt but had visible swelling in chin and ankle and possibly thighs. The outcome of the events was reported as unknown.   Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Restricted mobility in my leg; My knees weren't bending fully; I feel a visible pain in my ankle and my finger; I feel a visible pain in my ankle and my finger; I have visible swelling in my chin and my ankle and possibly my thighs; I have visible swelling in my chin and my ankle and possibly my thighs; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Jun2021 as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (Lot: unknown) on unknown date via an unspecified route of administration for COVID-19 immunisation. On 16Jun2021, patient got the second vaccine at about 04:30 eastern about 9 or 10 hours ago and after 6 hours after getting the vaccine or 5 hours (as reported) after the vaccine the second shot, felt a little bit restricted mobility in leg and knees weren't bending fully and right now 12 hours after the second dose and felt a visible pain in ankle and finger it did not hurt but had visible swelling in chin and ankle and possibly thighs. The outcome of the events was reported as unknown.   Information about lot/batch number has been requested.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Lymphadenopathy, Lymphoproliferative disorder, SARS-CoV-2 antibody test
Clinical narrative: lymphoproliferative disorder; Enlarged lymph glands supraclavicular; This a spontaneous report from a Pfizer employee received from a contactable pharmacist. A 14-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot Number: ER8735) via intramuscularly administered in left arm on 22May2021 15:00 as single dose for COVID-19 immunization. Medical history included prior heart transplant and patient had known allergies to Amoxicillin, tree nuts/peanuts. Concomitant medications within 2 weeks of vaccination included Cyclosporine, Prednisone, Azathioprine and among other supplments. On 09Jun2021, the patient experienced lymphoproliferative disorder and enlarged lymph glands supraclavicular. The patient was hospitalized for both the events for 6 days. The outcome of the events was recovering. The patient underwent lab tests and procedures which included sars-cov-2 antibody test (Nasal Swab) was negative on 04Jun2021. The patient had enlarged lymph glands supraclavicular in addition to lymph tissue in chest based on CT scan. It was reported that the events may have started prior to vaccine administration however reporting this as vaccine was administered in the weeks prior to enlarged lymph being reported by patient. The most recent COVID-19 vaccine was administered at public health clinic. The patient receives no other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Patient visited Emergency room/department or urgent care for events. Outcome of events was recovering.  Information on batch/lot no. were available. Further information has been requested.; Sender's Comments: Based on temporal relationship, there is reasonable possibility of causal association between the event Lymphoproliferative disease and Lymphadenopathy and the suspect drug 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: Menstruation irregular
Clinical narrative: Period had advanced; This is a spontaneous report from a Pfizer sponsored program. A contactable dentist (patient's mother) reported that: A 13-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced period had advanced. It was reported that she didn't show any reaction during the first dose only her period had advanced. The outcome of event was unknown.  Information about batch/ lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus
Clinical narrative: allergic reaction; itching throat, mouth, lips; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Feb2021 as single dose for COVID-19 immunization. The patient's medical history included asthma (went home where patient had to continue BENEDRYL and asthma medication for the next). There were no concomitant medications reported. On an unspecified date in Feb2021, the patient received first COVID shot and had an allergic reaction. Within in 10 minutes of receiving the vaccine, the patient experienced itching throat, mouth, and lips. Treatment was received for the events with a shot of BENEDRYL, went home where patient had to continue BENEDRYL for the next two days. Patient was advised by allergist not to get the second shot. Would like to know when patient should try a COVID vaccine again. Outcome of the events was reported as unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Asthenia, Cognitive disorder, Knee deformity, Paralysis
Clinical narrative: anaphylaxis; paralysis of her limbs; cognitively struggling; weak; her legs keep buckling; This is a spontaneous report from a contactable consumer (Patient mother). A 20-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 24May2021 at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced anaphylaxis. Caller stated, reporter took her daughter to the ER because she keeps experiencing paralysis of her limbs that comes and goes. reporter spoke to the doctor who said to give the body a chance, it went through a reaction, gave the time it needed and it gets worse and worse. reporter stated her daughter was weak and cognitively struggling, that her limbs are very weak, and that she needs assistance because her legs keep buckling.The outcome of the events were unknown.  Information about batch/Lot number has been requested.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Pain, Pyrexia
Clinical narrative: Felt very weak; Body ache; Body temperature of about 100.6F; This is a spontaneous report from a contactable consumer (patient's mother).  A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number  and expiration date: not reported), via an unspecified route of administration, on 15Jun2021 at 17:15 (at the age of 15-year-old), as 1ST DOSE, SINGLE for covid-19 immunization .The patient medical history was not reported. The patient's concomitant medications were not reported.  On 15Jun2021, the patient felt very weak, body ache and body temperature of about 100.6F for over 24 hours now. The reporter would like to know what they need to do about it. Also wants to know if these has been reported side effects post-vaccination; and if so, how long does this usually lasts. The patient underwent lab tests and procedures which included body temperature: 100.6 Fahrenheit on 16Jun2021.  The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Pain, Pyrexia
Clinical narrative: nauseated (with no vomiting); fever; diarrhea; achy; This is a spontaneous report from a contactable consumer (patient himself). A 49-year-old male patient received bnt162b2, dose 2 via an unspecified route of administration on an unknown date 2021 (Batch/Lot number was not reported, Solution for injection) as single dose for covid-19 immunisation; dupilumab (DUPIXENT), subcutaneous from an unknown date Jan2021 (Batch/Lot number was not reported; Expiration Date: 30Jul2022) to an unspecified date, at 300 mg, every other week for chronic rhinosinusitis with nasal polyps. The patient medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC, 10 mg) at 10 mg, budesonide (PULMICORT) at 0.5 mg, fluoxetine hcl at 10 mg and salbutamol sulfate (ALBUTEROL SULFATE HFA) taken for an unspecified indication. The patient previously took aspirin for allergy (At the time of the event, the patient had ongoing allergy with aspirin). Historical vaccine included bnt162b2, dose 1 via an unspecified route of administration on an unknown date 2021 (Batch/Lot Number: Unknown) as single for covid-19 immunisation. The patient reported that he received his second dose of the Pfizer covid vaccine on Saturday (unspecified date in 2021) and on Sunday (unspecified date in 2021), he started to feel nauseated (with no vomiting), fever, diarrhea and achy. He was fine now. It was unknown if the patient experienced any additional symptoms/events. The patient stated that his sinuses was clear today than normal. The action taken in response to the events for dupilumab was unknown. The outcome of the events was resolving.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Possible blood clot in left leg; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 22Mar2021 14:00 (Lot Number: EP7534) as 2nd dose single dose at the age of 62-year-old for covid-19 immunisation. Historic vaccine included bnt162b2 dose 1 via an unspecified route of administration, administered in left arm on 01Mar2021 14:00 (Lot Number: EN6203) as 1st dose single dose at the age of 62-year-old for covid-19 immunisation. Medical history included heart, diabetes, gastrooesophageal reflux disease(gerd), arthritis, high blood pressure (HBP) from an unknown date. Past drug event included diltiazem (CARDIZEM) and experienced known allergies to diltiazem. Concomitant medications included clopidogrel bisulfate (PLAVIX), acetylsalicylic acid (ASPIRIN), metformin, metoprolol, and semaglutide (OZEMPIC), all taken for an unspecified indication, within 2 weeks of vaccination. The patient experienced possible blood clot in left leg on 19May2021 05:00. The adverse event result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of event. 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. No other vaccine in four weeks. The outcome of event was not recovered.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Erythema, Eye irritation, Feeling hot, Lip pruritus
Clinical narrative: My cheeks were very red and hot; My cheeks were very red and hot; Above my upper lip is itchy.; Sensation in the back of my left cheek in front of my ear; My eyes are very red and irritated; My eyes are very red and irritated; The rest of my face especially my checks and beneath my nose also feel like they are swelling; This is a spontaneous report from a contactable consumer (patient) reporting for herself.  A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the right arm on 30Apr2021 at 11:30 (Batch/Lot Number: EW0167) as 2ND DOSE, SINGLE (at the age of 64 years old) for covid-19 immunisation.  Medical history included allergy to pencillin, and mold/seasonal allergies from an unknown date. Concomitant medication(s) included trazodone hydrochloride (TRAZODON) taken for an unspecified indication, start and stop date were not reported, sleep aid, and multi vitamin.  The patient previously took first dose of BNT162B2, lot number ER8729, for covid-19 immunisation on 09Apr2021 at 12:00PM in the right arm and stated the day after her first shot her upper lip felt like it was swelling. For the next two weeks her lips continued to feel swollen but then would sting.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced eyes are very red and irritated (ocular hyperaemia) (medically significant) on 2021 with outcome of not recovered, the rest of her face especially her checks and beneath her nose also feel like they are swelling on 2021 with outcome of not recovered, her cheeks were very red and hot on 26May2021 with outcome of not recovered, above her upper lip is itchy on 2021 with outcome of not recovered, and sensation in the back of her left cheek in front of her ear on 2021 with outcome of not recovered. Therapeutic measures were taken as a result of eyes are very red and irritated, the rest of her face especially her checks and beneath her nose also feel like they are swelling, her cheeks were very red and hot, above her upper lip is itchy, and sensation in the back of her left cheek in front of her ear. The events resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   Follow-up attempts are needed. further information has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Swelling face
Clinical narrative: My cheeks were very red and hot; My cheeks were very red and hot; Above my upper lip is itchy.; Sensation in the back of my left cheek in front of my ear; My eyes are very red and irritated; My eyes are very red and irritated; The rest of my face especially my checks and beneath my nose also feel like they are swelling; This is a spontaneous report from a contactable consumer (patient) reporting for herself.  A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the right arm on 30Apr2021 at 11:30 (Batch/Lot Number: EW0167) as 2ND DOSE, SINGLE (at the age of 64 years old) for covid-19 immunisation.  Medical history included allergy to pencillin, and mold/seasonal allergies from an unknown date. Concomitant medication(s) included trazodone hydrochloride (TRAZODON) taken for an unspecified indication, start and stop date were not reported, sleep aid, and multi vitamin.  The patient previously took first dose of BNT162B2, lot number ER8729, for covid-19 immunisation on 09Apr2021 at 12:00PM in the right arm and stated the day after her first shot her upper lip felt like it was swelling. For the next two weeks her lips continued to feel swollen but then would sting.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced eyes are very red and irritated (ocular hyperaemia) (medically significant) on 2021 with outcome of not recovered, the rest of her face especially her checks and beneath her nose also feel like they are swelling on 2021 with outcome of not recovered, her cheeks were very red and hot on 26May2021 with outcome of not recovered, above her upper lip is itchy on 2021 with outcome of not recovered, and sensation in the back of her left cheek in front of her ear on 2021 with outcome of not recovered. Therapeutic measures were taken as a result of eyes are very red and irritated, the rest of her face especially her checks and beneath her nose also feel like they are swelling, her cheeks were very red and hot, above her upper lip is itchy, and sensation in the back of her left cheek in front of her ear. The events resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   Follow-up attempts are needed. further information has been requested.
Age: 14.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: expired Tenivac was accidentally administered to a patient, with no reported adverse event; Initial information received on 10-Jun-2021 regarding an unsolicited valid non-serious case from a nurse practitioner (under reference id 00636554).  This case involves a 14 years old female patient who was accidentally administered with 0.5 ml expired dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (booster, lot number U6187AA and expiration date: 06-Feb-2021) via an unknown route in the right deltoid for prophylactic vaccination on 10-Jun-2021 at 13:15 (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other vaccines were given to the patient.  It was a case of an actual medication error due to expired vaccine used (same day latency).   Reported that caller would like to find out about next steps.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.