chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: caller received his first dose of the Pfizer Covid vaccine in March and then got Covid; caller received his first dose of the Pfizer Covid vaccine in March and then got Covid; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A male patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Mar2021, as single dose (Batch/Lot number was not reported) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got Covid after first dose in 2021. The patient was unsure if he should now restart the series or get the second dose. He had talked to multiple doctors and one said he can start again after waiting 3 months and another doctor said he should wait and start all over again. He stated he was still confused and didn't know what to do. Everyone was giving him different answers and it was still very very confusing. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report from a non-contactable HCP. 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 an unspecified date as dose number unknown single for COVID-19 immunization. Medical history was not reported. Concomitant medications included rituximab (RITUXAN). It was reported that adverse reaction concerning a patient who used one of your products, Pfizer COVID-19 vaccine. On unknown date. it was reported that patient experienced: COVID-19. The outcome of the reported event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information in the case report, A possible causal relationship between Covid-19 and suspect product BNT162B2 cannot be excluded.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer. This 90-year-old female consumer (patient). A 90-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 23Mar2021 as dose 1, single for COVID-19 immunization; varicella zoster vaccine rge (cho) (SHINGRIX), via an unspecified route of administration from 13May2021 (Batch/Lot number was not reported) to 13May2021, at dose 2, SINGLE for an unspecified indication. The patient's medical history and concomitant medications were not reported. Caller stated that she was a 90-year-old lady who received the two-dose series of the Pfizer COVID-19 vaccine. She stated that in between the two doses she had to fit her number two shingle, Shingrix inoculation. She stated that she got the shingrix vaccine on 13May2021. The patient reported that the pharmacist told her that would be a safe date away from 23Mar2021 for the first Pfizer dose and her new date for the second dose was postponed till 22Jun2021. The patient thought that would be enough time as well. She stated that something went wrong, terribly wrong. She stated that this was the second attack of shingles that she has had in-between 01Jun2021 was number one and that day (yesterday) was number two. It was on her face, in the same place and same symptoms only this time it was spreading very fast and the medication. The reporter wanted information on what to do, she stated there was a bulletin on a news network that she listened to and it said that the Pfizer COVID-19 had an unusually of people calling in that they had developed shingles after they had their inoculations. Even though they had protection like her. She wanted to know if that was correct. She stated she would love information because she was going crazy. Caller asked for a web address that her family can look up on the net so they can get further information for her. Something they could find out on their computer because she was not getting any information and her doctor was on vacation and she was suffering badly from a horrible outbreak all over her face and chest. She asked if that's the best they could do. Caller was referred back to her doctor or the doctor that was covering for her doctor while he was out of town. She stated that she had been getting help. she was just wondering and wanted more information on if this was going to be common because within six weeks, she has had exactly the same outbreak within six weeks. Treatment medication was received for the event shingles (she had been on the medication fully for 3 days then). Outcome of the event was reported as unknown at this time of the report.   Information on lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Contusion, Neck pain, Pain in extremity, Vaccination site haemorrhage
Clinical narrative: Joint pain, already had some sort of joint pain before this just amplified it a bit; Arms hurt; Arms hurt, where it was given and mine bruised up; Felt like it attack my joint in my neck specifically; When they gave me mine, mine bled; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0164) via an unspecified route of administration in Deltoid Left on 22Jul2021 at 11:30 (at the age of 37 years old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did not received any vaccination 4 weeks prior to COVID 19 Vaccine. The patient experienced joint pain, already had some sort of joint pain before this just amplified it a bit, arms hurt, where it was given and mine bruised up, felt like it attack my joint in my neck specifically, when they gave the patient, mine bled on an unspecified date on Jul2021. Reported as, the patient had received it as well yesterday the only side effect that the patient experienced was that the patient was still experiencing joint pain but that was not anything would really call about because the patient have already had some sort of joint pain before this just amplified it a bit. The patient have arms hurt, where it was given and bruised up and did not bruised up but both of our arms hurt a bit. Other medical conditions consumer stated, the patient had problems with neck, the patient had bulging disc and stuff like that so that was ongoing problem for me personally and so like the patient said the patient already had joint pain but when got that, the patient felt like it was and felt like it attacked joint in neck specifically where the patient already had the problem, so the pain was amplified. Consumer stated, no the patient not other than Ibuprofen here and there for pain and swelling from that other issue that the patient already have hurt too but when they gave the patient's bled and that never happened to the patient, it bled and it made a pump and then nthe patient woke up this morning and it was bruised and of course it was still hurts. But his just hurts". As a corrective treatment the patient did not received any medication other than Ibuprofen. the patient took Ibuprofen for try to help the pain. Therapeutic measures were taken for the event arthralgia, pain in extremity, contusion, and neck pain. The outcome of all the events were unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Feeling abnormal, Headache, Nasopharyngitis
Clinical narrative: Chest pain; Very much sourness of breath; Cold like from inside out it was very weird; No energy at all.; Headache, started like at temples and went up to like my forehead and I really have a headache at all; Twinkling my toes; Feet were very swollen; This is a spontaneous report from a contactable consumer (patient). A 60 years old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration, administered in Arm Right on 16Apr2021 (at the age of 59 years old) (Batch/Lot Number: EN6199) as dose 1, single for covid-19 immunisation.  Medical history included ongoing smoker (I done smoke). The patient's concomitant medications were not reported. Date of administration of first shot: 16Apr2021. Consumer stated, "Side effects, I had chest pain, very much sourness of breath and , I've never had this problem before ever, I done smoke, I am not over weight, I had cold like from inside out it was very weird, no energy at all, headache and it started like at temples and went up to like my forehead and I really have a headache at all, twinkling my toes and I still have that and my feet were very swollen." Product details (Expiration date, NDC#, UPC#): Consumer stated, "I have a paper for this vaccination so it says, so it has a LOT#, so if you want me to go and get the vaccination card well it will take me a couple of minutes, you want me to get it, I have to go stairs and get it". No therapeutic measures were taken as a result of events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Respiration abnormal
Clinical narrative: Chest pain; Very much sourness of breath; Cold like from inside out it was very weird; No energy at all.; Headache, started like at temples and went up to like my forehead and I really have a headache at all; Twinkling my toes; Feet were very swollen; This is a spontaneous report from a contactable consumer (patient). A 60 years old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration, administered in Arm Right on 16Apr2021 (at the age of 59 years old) (Batch/Lot Number: EN6199) as dose 1, single for covid-19 immunisation.  Medical history included ongoing smoker (I done smoke). The patient's concomitant medications were not reported. Date of administration of first shot: 16Apr2021. Consumer stated, "Side effects, I had chest pain, very much sourness of breath and , I've never had this problem before ever, I done smoke, I am not over weight, I had cold like from inside out it was very weird, no energy at all, headache and it started like at temples and went up to like my forehead and I really have a headache at all, twinkling my toes and I still have that and my feet were very swollen." Product details (Expiration date, NDC#, UPC#): Consumer stated, "I have a paper for this vaccination so it says, so it has a LOT#, so if you want me to go and get the vaccination card well it will take me a couple of minutes, you want me to get it, I have to go stairs and get it". No therapeutic measures were taken as a result of events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: My daughter is in hospital in (Place). She suffered a stroke.; This is a spontaneous report from a contactable consumer (patient's mother). A 55-year-old female received the second dose of BNT162B2  (PFIZER BIONTECH COVID 19 VACCINE) via an unspecified route of administration on 10Apr2021 (Lot Number: EW0150) at the age of 55-year-old as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on 20Mar2021 (Batch/lot number: EN6206; Expiration Date: Unknown) at the age of 55-year-old as single dose for COIVD-19 immunization. On 08Jul2021, the patient suffered a stroke and was in hospital. The reporter was very interested and need help. The reporter stated he recently saw the article online with the testing of the article talked about patients was written by people in (Place) pretraining by the Pfizer vaccine side effects and wanted to know what if any studies could being done that can may be help her daughter. The event was resulted in hospitalization. The outcome of event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Dysgeusia, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: metallic taste; dry mouth; Making him miserable; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration in Feb2021 as dose 2 single in left arm for COVID-19 immunization. Medical history and Concomitant medications were not reported. Prior Vaccinations (within 4 weeks) were none. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date in 2021 for COVID-19 Immunization. Patient reported having metallic taste in his mouth and a dry mouth for the last 2-3 months in 2021. Says they are persisting. stated it was making him miserable in 2021. For adverse events dry mouth, very metallic taste in mouth patient visited to Physician Office. About 3 weeks ago he had a Covid 19 Test done and it was negative in 2021. The outcome of events was not recovered.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Hookworm infection, Hypoaesthesia, Insomnia, Rash
Clinical narrative: Dying from Bels Palsy; hook worms/ the worms that are in his stool are half an inch Long and have scales on them; lefts sides of his face and body was numb and puffy; lefts sides of his face and body was numb and puffy; rashes; loosing weight; hasn't been able to sleep; This is a spontaneous report from a non-contactable consumer, the patient.   A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller stated he received I shot of the Pfizer COVID-19 vaccine and is now dying from Bell's Palsy and hook worms. Caller stated 35 hours after receiving the vaccine he woke up and the lefts Side of his face and body was numb and puffy, he had rashes, loosing weight, and has been suffering from hook worms. Caller stated the worms are in his stool. back on his hands, calves, gond area and back of his neck. Caller stated the worms that are in his stool are half an inch Long and have scales on them. Caller stated he hasn't been able to sleep for the past 2 hours. Caller stated he was hospitalized Tuesday and is now back at the hospital trying to get to test his stool samples. Caller stated the tiny worms come to the surface of his skin and this started to happen a month after receiving the vaccine. The patient underwent lab tests and procedures which included stool analysis that showed the worms are in his stool on an unknown date (caller stated the worms are in his stool/ Caller stated the worms that are in his stool are half an inch Long and have scales on them). The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Skin swelling, Stool analysis, Weight decreased
Clinical narrative: Dying from Bels Palsy; hook worms/ the worms that are in his stool are half an inch Long and have scales on them; lefts sides of his face and body was numb and puffy; lefts sides of his face and body was numb and puffy; rashes; loosing weight; hasn't been able to sleep; This is a spontaneous report from a non-contactable consumer, the patient.   A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller stated he received I shot of the Pfizer COVID-19 vaccine and is now dying from Bell's Palsy and hook worms. Caller stated 35 hours after receiving the vaccine he woke up and the lefts Side of his face and body was numb and puffy, he had rashes, loosing weight, and has been suffering from hook worms. Caller stated the worms are in his stool. back on his hands, calves, gond area and back of his neck. Caller stated the worms that are in his stool are half an inch Long and have scales on them. Caller stated he hasn't been able to sleep for the past 2 hours. Caller stated he was hospitalized Tuesday and is now back at the hospital trying to get to test his stool samples. Caller stated the tiny worms come to the surface of his skin and this started to happen a month after receiving the vaccine. The patient underwent lab tests and procedures which included stool analysis that showed the worms are in his stool on an unknown date (caller stated the worms are in his stool/ Caller stated the worms that are in his stool are half an inch Long and have scales on them). The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Body temperature, Chills, Dyspnoea
Clinical narrative: feels bad; felt body aches; stuff and real weak; feeling sick in her stomach; chills; low-grade fever; light headache/headache; Out of breath just a little; I am sick; difficult for her to breathe; This is a spontaneous report from a Pfizer sponsored program. This is a contactable consumer or other non hcp reported for herself. A 55-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6202) via an unspecified route of administration on 27Feb2021 (Age at Vaccination 55years old) as single dose for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing Verbatim: Bronchitis asthmatic, hypersensitivity from an unknown date and unknown if ongoing Verbatim: Allergy. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); montelukast sodium (SINGULAIR); ibuprofen (MOTRIN [IBUPROFEN]); paracetamol (TYLENOL) all taken for an unspecified indication, start and stop date were not reported. In Feb2021 the patient experienced difficult for her to breathe, out of breath just a little, i am sick, on 27Feb2021 light headache/headache, on 28Feb2021 feeling sick in her stomach, chills, low-grade fever, felt body aches, stuff and real week, on 01Mar2021 feels bad. Clinical course reported as she was just wondering, she wants to make sure about taking the second vaccine. she just got her first one on Saturday of this week. She is having a reaction to it, it's not bad, she is sick really bad with a headache and sick on my stomach. Yesterday I was running low grade fever and just felt body aches and stuff and real week. When paraphrased the concern, patient stated, Yes, if I should because yesterday my breath (Incomplete sentence), because I have asthmatic bronchitis and I didn't get really bad about it, out of breath just a little yesterday not real bad. When confirmed if the vaccine is Pfizer's Covid 19 vaccine, consumer stated, "Yes ma'am I am teacher since then we haven't been going out since Saturday morning. Treatment: she started the Motrin and Tylenol; she has been taking back and forth. she started this Saturday like before her even got the shot, she had already started it. The patient under-went lab tests and procedures which included body temperature: low grade fever on 28Feb2021 Low grade fever. The clinical outcome of the event low-grade fever was recovered, another events light headache/headache, feels bad was not recovered other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Illness, Pain, Pyrexia
Clinical narrative: feels bad; felt body aches; stuff and real weak; feeling sick in her stomach; chills; low-grade fever; light headache/headache; Out of breath just a little; I am sick; difficult for her to breathe; This is a spontaneous report from a Pfizer sponsored program. This is a contactable consumer or other non hcp reported for herself. A 55-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6202) via an unspecified route of administration on 27Feb2021 (Age at Vaccination 55years old) as single dose for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing Verbatim: Bronchitis asthmatic, hypersensitivity from an unknown date and unknown if ongoing Verbatim: Allergy. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); montelukast sodium (SINGULAIR); ibuprofen (MOTRIN [IBUPROFEN]); paracetamol (TYLENOL) all taken for an unspecified indication, start and stop date were not reported. In Feb2021 the patient experienced difficult for her to breathe, out of breath just a little, i am sick, on 27Feb2021 light headache/headache, on 28Feb2021 feeling sick in her stomach, chills, low-grade fever, felt body aches, stuff and real week, on 01Mar2021 feels bad. Clinical course reported as she was just wondering, she wants to make sure about taking the second vaccine. she just got her first one on Saturday of this week. She is having a reaction to it, it's not bad, she is sick really bad with a headache and sick on my stomach. Yesterday I was running low grade fever and just felt body aches and stuff and real week. When paraphrased the concern, patient stated, Yes, if I should because yesterday my breath (Incomplete sentence), because I have asthmatic bronchitis and I didn't get really bad about it, out of breath just a little yesterday not real bad. When confirmed if the vaccine is Pfizer's Covid 19 vaccine, consumer stated, "Yes ma'am I am teacher since then we haven't been going out since Saturday morning. Treatment: she started the Motrin and Tylenol; she has been taking back and forth. she started this Saturday like before her even got the shot, she had already started it. The patient under-went lab tests and procedures which included body temperature: low grade fever on 28Feb2021 Low grade fever. The clinical outcome of the event low-grade fever was recovered, another events light headache/headache, feels bad was not recovered other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Gait disturbance, X-ray
Clinical narrative: after second dose the shortness of breath and difficulty breathing began to get worse; challenging for him to walk around as he normally could; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration (at the age of 65-year-old) on 02Mar2021 (Lot number: unknown) as single dose for COVID-19 immunisation. Medical history included allergic to fish oil. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration (at the age of 65-year-old) on 09Feb2021 as single dose for COVID-19 immunisation and experienced shortness of breath and difficulty breathing. The patient previously took simvastatin (ZOCOR) and experienced allergic. Patient reports that he received both dose of vaccine. First dose on 09Feb2021, second dose 02Mar2021. Patient had an x-ray (negative for any findings per patient) and was prescribed prednisone. Patient reports that the symptoms got better but never went away. Patient states after second dose the shortness of breath and difficulty breathing began to get worse again. Patient also mentions is challenging for him to walk around as he normally could. Patient states he was fine until he took the shot and he needs to know what he was supposed to do. Caller reports that he cannot afford to got to hospital. Patient would like to know how long his symptoms will last, if his lungs are good then what can it be. Patient got the 2 doses of Pfizer covid-19 vaccine, he stated that he was experiencing difficulty of breathing (DOB) and he wants to talk to a pharmacist to know what was the cause why he had that on an unspecified date in Mar2021. The patient underwent lab tests and procedures which included x-ray: negative on Feb2021 negative for any findings per patient. Therapeutic measures were taken as a result of after second dose the shortness of breath and difficulty breathing began to get worse. The outcome of the event dyspnoea was not recovered and other event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Eczema, Rash
Clinical narrative: egg-sized lump in left armpit; I got a rash on chest, face, neck, and behind the ears; I got a rash on chest, face, neck, and behind the ears; I got a rash on chest, face, neck, and behind the ears; I got a rash on chest, face, neck, and behind the ears; This is a spontaneous report from a contactable consumer or other non hcp.     A 54-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EN6200), dose 2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 18:00 as dose 2, single for covid-19 immunisation Medical history included blood cholesterol increased, hypertension, depression. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.It was Reported that, egg-sized lump in left armpit and about 40 hours after injection, got a rash on chest, face, neck, and behind the ears on 07Mar2021 14:30 with outcome of recovering  No follow up attempts are possible. No further information is expected.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Epistaxis, Hypertension
Clinical narrative: nose bleed; Atrial Fibrillation; hypertension; This is spontaneous report from a contactable consumer or other non HCP. The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 19Jul2021, this case now contains all required information to be considered valid.   A 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL1283, Expiration date: unknown), via unspecified route of administration in the right Arm, on 28Jan2021 at 12:00 PM, (at the age of 84-year-old) as dose 1, single for COVID-19 Immunisation. Medical history included blood too thin to coagulate. Concomitant medications included warfarin taken for Blood too thin to coagulate start and stop date was not reported, acetylsalicylic acid (ASPIRIN 81) taken for unspecified indication start and stop date was not reported. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3302), via unspecified route of administration in the left shoulder, on 19Mar2021 at 11:00 AM, as dose 2, single for COVID-19 Immunisation.  On 10Feb2021 at 07:15 PM, the patient experienced nosebleed. On an unknown date, the patient experienced hypertension and atrial Fibrillation. The patient visited 3 times to emergency room for bleeding and received two transfusions to stop bleeding and kept in hospital until 19Feb2021. On an unknown date, the patient transferred to ENT physician. It was reported that he was hospitalized and couldn't make it to appointment for second dose on 26Feb2021. Prior vaccinations within 4 weeks were none. The patient was visiting her primary care physician and cardiologist regularly. The outcome of the events were not recovered.    Information about lot/batch number has been requested.  Follow-up (19Jul2021): The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (19Jul2021), this case now contains all required information to be considered valid. new information added which included suspect product detail, event detail, Patient age at time of vaccination, patient medical history was updated.  Follow-Up (23Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ear haemorrhage, Ear pain
Clinical narrative: Bleeding ear same side as vaccine; earache opposite side; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9267), via an unspecified route of administration in the left arm on 15Feb2021 at 12:00 (at the age of 70-year-old) as dose 1, single for COVID-19 immunisation in public health clinic/administration facility. Medical history included heart attack from an unknown date and unknown if ongoing (Heart attack 6 years ago but am in great condition no heart defects). Concomitant medications included venlafaxine taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported; irbesartan taken for an unspecified indication, start and stop date were not reported; ascorbic acid (VIT C) taken for an unspecified indication, start and stop date were not reported; curcuma longa (TURMERIC) taken for an unspecified indication, start and stop date were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that the patient experienced bleeding ear same side as vaccine 10 days later (15Jul2021) earache opposite side. The patient did not receive any treatment for the events. The outcome of the events was reported as resolved.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Illness
Clinical narrative: could not breath; chest pain; Really sick; This is a spontaneous report from a contactable consumer or other non hcp.     A 63-years-old female patient received bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, (Batch/Lot number was not reported) dose 1 via an unspecified route of administration on an unspecified date 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. It was Reported that, she got her first shot of the Pfizer Covid 19 vaccine 3 weeks ago and got really sick after that and also, she was taken to the ER as she could not breath and experienced chest pain. The outcome of the events was unknown on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: High fever; Muscle aches; Headache; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received her unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: EL3247) via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks. On 30Mar2021, the patient experienced high fever, muscle aches, headache and nausea. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events of high fever, headache, nausea and myalgia was recovering at time of this report.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1, Lab data "Body temperature" removed since only High fever was provided in the source document. 2, Vaccination Facility Country added. 3, Final sentence updated.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Implant site pain, Muscle spasms
Clinical narrative: extreme cramping for two days after both covid vaccinations; severe pain where metal implants in my body (hip and neck); This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the left arm on 25Feb2021 (at the age of 53-year-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the right arm on 18Mar2021 for COVID-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing Prior to vaccination, spinal fusion surgery fused vertebrate in neck, hip arthroplasty artificial hip, medical device implantation (metal implants in my body (hip and neck), glucose tolerance impaired all are from an unknown date and unknown if ongoing. Concomitant medication included hepatitis a vaccine (HEPATITIS A) taken for an unspecified indication from 08Feb2021; hepatitis b vaccine (HEPATITIS B VACCINE) taken for an unspecified indication from 08Feb2021. The patient did not have allergies to medications, food, or other products. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced extreme cramping on 26Feb2021 at 05:00 for two days and severe pain in neck and hip where metal implants were present after both covid vaccines. It was reported that this was still occurring at the time of this report. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. It was reported that Adverse event: extreme cramping for two days after both covid vaccinations, followed by severe pain where I have metal implants in my body (hip and neck). This was still occurring.Prior to vaccination, was the patient diagnosed with COVID-19 was yes. No treatment was received. The clinical outcome of the events cramps and the implant site pain were not recovered.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: For suspect vaccine 2nd dose: "Anatomical Location" captured as "Arm Right" per source, 1st Dose "Hepatitis A" and 1st/2nd Dose "Hepatitis B Vaccine" captured as "Historical Vaccine", "metal implants in my body (hip and neck)" captured as History per verbatim, Suspect "HEPATITIS A" updated  per event's onset, No Drug code for "Hepatitis b", coded in tab as "HEPATITIS B VACCINE"; And also updated from event's onset. Initial information need review.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I just had a sore arm; This is a spontaneous report from a non-contactable consumer (patient) or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. Medical history included severe Fibromyalgia. The patient's concomitant medications were not reported. The patient had received dose 1 of bnt162b2 on an unknown date for covid-19 immunisation. The patient experienced i just had a sore arm on an unspecified date (the patient was concerned that the second vaccine would lead to a flare). Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Severe case of shingles on the right side of my face.; This is a spontaneous report from a contactable consumer. This 59-year-old female consumer (patient) reported for herself that she received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 20Mar2021 18:00 (Batch/Lot Number: Ep7534) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Age at vaccination was 59 year. The patient medical history and concomitant medication was not reported. The patient experienced severe case of shingles on the right side of my face on 25Mar2021. Therapeutic measures were taken as a result of severe case of shingles on the right side of my face. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Headache, Heart rate, Heart rate increased
Clinical narrative: Nausea; Fatigue; headaches; BP was quite low, as low at 80/57; increased heart rate between 101bpm and 158bpm while stagnant working a desk job and as high as 133 bmp at 12:50 am; didn't sleep for 48 hours; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at the age of 48-years-old), dose 1 via an unspecified route of administration, administered in arm left in Mar2021 (17:30) (Batch/Lot Number: ER2613) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included lacosamide (VIMPAT); diphenhydramine hydrochloride (BENADRYL); and melatonin. The patient previously took NORTON and experienced drug hypersensitivity. The patient was not pregnant. The patient had no other vaccine in four weeks prior to COVID-19 vaccine. She had no covid prior vaccination; she had not been tested for covid post vaccination. The patient experienced adverse events of nausea, fatigue, but didn't sleep for 48 hours (started in Mar2021), headaches and most importantly an increased heart rate between 101 bpm and 158 bpm while stagnant working at a desk job and as high as 133 bmp at 12:50 am which the patient should have been sleeping. Her BP was quite low, as low at 80/57 at one point. The event "didn't sleep for 48 hours" started on an unspecified date in Mar2021,  heart rate increased was on 30Mar2021 00:50; while the other events started on 30Mar2021 12:00 PM (as reported). The outcome of "didn't sleep for 48 hours" was unknown other events were recovered in 2021. The patient had not received treatment for the events.   No follow up attempts are needed; no further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Insomnia, Nausea
Clinical narrative: Nausea; Fatigue; headaches; BP was quite low, as low at 80/57; increased heart rate between 101bpm and 158bpm while stagnant working a desk job and as high as 133 bmp at 12:50 am; didn't sleep for 48 hours; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at the age of 48-years-old), dose 1 via an unspecified route of administration, administered in arm left in Mar2021 (17:30) (Batch/Lot Number: ER2613) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included lacosamide (VIMPAT); diphenhydramine hydrochloride (BENADRYL); and melatonin. The patient previously took NORTON and experienced drug hypersensitivity. The patient was not pregnant. The patient had no other vaccine in four weeks prior to COVID-19 vaccine. She had no covid prior vaccination; she had not been tested for covid post vaccination. The patient experienced adverse events of nausea, fatigue, but didn't sleep for 48 hours (started in Mar2021), headaches and most importantly an increased heart rate between 101 bpm and 158 bpm while stagnant working at a desk job and as high as 133 bmp at 12:50 am which the patient should have been sleeping. Her BP was quite low, as low at 80/57 at one point. The event "didn't sleep for 48 hours" started on an unspecified date in Mar2021,  heart rate increased was on 30Mar2021 00:50; while the other events started on 30Mar2021 12:00 PM (as reported). The outcome of "didn't sleep for 48 hours" was unknown other events were recovered in 2021. The patient had not received treatment for the events.   No follow up attempts are needed; no further information expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Postmenopausal haemorrhage
Clinical narrative: 3-4 heavy days of cramping and menstruation, followed by 3-4 days of light cramping and menstruation/Patient is almost (age)years old and has not had a period in over 16 months; 3-4 heavy days of cramping and menstruation; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 22Mar2021 13:30 (at the age of 55-years-old) (Batch/Lot Number: EP7534) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history was none. There were no concomitant medications. She had no known allergies. The patient was not pregnant. The patient had no other vaccine in four weeks prior to COVID-19 vaccine. It was reported that the patient had 3-4 heavy days of cramping and menstruation, followed by 3-4 days of light cramping and menstruation. Patient was almost 56 years old and had not had a period in over 16 months. The events' onset was on 25Mar2021 08:00 AM. The event has recovered without treatment. The patient had no covid prior vaccination.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Pruritus, Rash erythematous, Vaccination site mass, Vaccination site pain
Clinical narrative: Event: Right arm is really sore where they put the needle in and has a big knot, size of an egg and it is really hard and has a red rash and itches. was reported as worsened.; has a red rash; itches; has a big knot, size of an egg and it is really hard; Right arm is really sore where they put the needle in; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: ER8733 and expiration date was not reported), via an unspecified route of administration in right arm on 26Mar2021 at 13:03 (at the age of vaccination 74-years-old) as dose 1, single for COVID-19 immunisation in hospital. On 12Apr2021 she has second shot. The patient's medical history included breast cancer and part of breast removed in 2010. No history of all previous immunization with the Pfizer vaccine considered as suspect. Prior Vaccinations (within 4 weeks) and AE(s) following prior vaccinations was none. Concomitant medications were not reported. On 28Mar2021, right arm was really sore where they put the needle in and has a big knot, size of an egg and it was really hard and a red rash and itches and was reported as worsened. Patient not had any problems with her arm because of it. The patient explained that she had the shot last Friday and it was not a week until tomorrow, but it was really sore where they put the needle in and she has a big knot the size of an egg and it was really hard and red on top, states she guesses that was a rash. At first it starts with itching really bad, and she would rub finger over it, now her whole arm was hurting. She had a rash and it started itching and she thought when it itched it'd be getting better and it started turning red and Sunday formed a knot and the knot kept getting bigger and bigger. States it can be seen when she wears long sleeves. States she tries not to sleep on it because she usually sleeps on right side but she has been sleeping on her back because her arm was sore and itching and she didn't want to cause it to get worse. No investigation assessment. The patient takes pain pills as treatment for her back anyhow and it helped the pain on her arm. The outcome of the adverse event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Event: Right arm is really sore where they put the needle in and has a big knot, size of an egg and it is really hard and has a red rash and itches. was reported as worsened.; has a red rash; itches; has a big knot, size of an egg and it is really hard; Right arm is really sore where they put the needle in; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: ER8733 and expiration date was not reported), via an unspecified route of administration in right arm on 26Mar2021 at 13:03 (at the age of vaccination 74-years-old) as dose 1, single for COVID-19 immunisation in hospital. On 12Apr2021 she has second shot. The patient's medical history included breast cancer and part of breast removed in 2010. No history of all previous immunization with the Pfizer vaccine considered as suspect. Prior Vaccinations (within 4 weeks) and AE(s) following prior vaccinations was none. Concomitant medications were not reported. On 28Mar2021, right arm was really sore where they put the needle in and has a big knot, size of an egg and it was really hard and a red rash and itches and was reported as worsened. Patient not had any problems with her arm because of it. The patient explained that she had the shot last Friday and it was not a week until tomorrow, but it was really sore where they put the needle in and she has a big knot the size of an egg and it was really hard and red on top, states she guesses that was a rash. At first it starts with itching really bad, and she would rub finger over it, now her whole arm was hurting. She had a rash and it started itching and she thought when it itched it'd be getting better and it started turning red and Sunday formed a knot and the knot kept getting bigger and bigger. States it can be seen when she wears long sleeves. States she tries not to sleep on it because she usually sleeps on right side but she has been sleeping on her back because her arm was sore and itching and she didn't want to cause it to get worse. No investigation assessment. The patient takes pain pills as treatment for her back anyhow and it helped the pain on her arm. The outcome of the adverse event was not recovered.  No follow-up attempts are possible. No further information is expected.