chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Back pain, Irritable bowel syndrome
Clinical narrative: I am too sick; terrible stomach and intestinal pain; This is a spontaneous report from a contactable consumer(patient herself) via Medical Information Team. A 90-years-old female patient 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 07Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date it was reported that the patient was too sick. The patient stated that 2 days later (after vaccination) she got terrible, terrible stomach and intestinal pain, and she still have them; almost like Colitis or Crohns or she dont know! but it feels that way! patient was supposed to take second on 05May2021, she asked, what do I do! I have any (vaccine dose) when I feel better, do I wait a couple of months, just stay with the one shot, if you can't have second shot what happens, you only have 1 shot or start all over, how much coverage do I have after first dose, She wanted to know if she should get the second dose of Pfizer-BioNTech COVID-19 Vaccine, Patient further stated, her cardiologist is her only HCP and does not want know anything about COVID-19 nor COVID-19 vaccination. Response was, as noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gastrointestinal disorder, Illness
Clinical narrative: I am too sick; terrible stomach and intestinal pain; This is a spontaneous report from a contactable consumer(patient herself) via Medical Information Team. A 90-years-old female patient 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 07Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date it was reported that the patient was too sick. The patient stated that 2 days later (after vaccination) she got terrible, terrible stomach and intestinal pain, and she still have them; almost like Colitis or Crohns or she dont know! but it feels that way! patient was supposed to take second on 05May2021, she asked, what do I do! I have any (vaccine dose) when I feel better, do I wait a couple of months, just stay with the one shot, if you can't have second shot what happens, you only have 1 shot or start all over, how much coverage do I have after first dose, She wanted to know if she should get the second dose of Pfizer-BioNTech COVID-19 Vaccine, Patient further stated, her cardiologist is her only HCP and does not want know anything about COVID-19 nor COVID-19 vaccination. Response was, as noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: He had the same issue; lower back pain problem; This is a spontaneous report from a contactable consumer (patient's brother). A male patient of an unspecified age received first dose of bnt162b2 (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced he had the same issue, lower back pain problem on an unspecified date. Last week in the process of to get his pants over his mother's house and his brother was already in there and he has had both shots and they asked him if he had any back problem or anything was going on and he had the same issue but he didn't ask his wife because she got same shot. He spoke to his brother if he had done that and he had the same we are just talking about this and when they asked him at facility when he went to the second one, if he had any lower back pain problem and he said yes, so, they matched that he was having issues with his back so it's a possibility that it was due to the shot but was fine. The outcome of event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Muscle spasms
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After vaccination, the patient had some issues with back spasms in lower back, and he felt pain, it was a short pain in lower back where the kidneys are on an unspecified date. Patient used a heating pad, vibrating heating pad that helped by bringing heating pad up so that he could get the muscles back, kept from spasm but after that he was fine. The outcome of events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Lymph nodes swollen and pain; Lymph nodes swollen and pain; This is a spontaneous report from a contactable consumer. A 21-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 20Apr2021 at 14:30 (at the age of 21 years old) as a single dose for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number /expiration date: not provided), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included meningitis as a child. Concomitant medication were not provided.  The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Apr2021 at 09:00, the patient experienced lymph nodes swollen and pain. She complains of feeling like she did when she had spinal meningitis as a child. The patient did not receive any treatment for these events. The outcome of the events lymph nodes swollen and pain was not recovered. Since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tiredness; This is a spontaneous report from a contactable consumer. This consumer reported for his colleague that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included aspirin [acetylsalicylic acid]. The reporter stated that a colleague of his (unknown age) took aspirin 2 hours before and 2 hours after his Pfizer shot. He told him that he only felt tiredness. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: after the first shot I was just tired for quite number of days; This is a spontaneous report from a contactable consumer (patient). An 80-years-old female patient received bnt162b2, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included primary biliary sycosis (liver disease), high blood pressure, stomach ulcers and breast cancer. The patient had liver disease, she had primary biliary cirrhosis, she also had 3 different times stomach ulcers in the past and 25 years she had breast cancer ( she didn't remember when she was diagnosed with that, it's been at least 15 years). Concomitant medications included ursodeoxycholic acid (URSODIOL) taken for primary biliary cirrhosis; metoprolol taken for high blood pressure and amlodipine taken for high blood pressure. After the first shot, she was just tired for quite number of days on an unspecified date. No treatment was received for the event. The outcome of the event was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pyrexia, Vaccination site erythema
Clinical narrative: I had a slight fever; I just did not feel good; underneath it, it was kind of red; I was terribly tired for about 10 days; This is a spontaneous report from a contactable consumer (patient). This 80-year-old female patient received second dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 06Apr2021 as single dose for covid-19 immunisation. The patient medical history included liver disease, primary biliary cirrhosis, 3 different times had stomach ulcers, breast cancer for at least 15 years and high blood pressure. The patient concomitant medications included ursodeoxycholic acid (URSODIOL) 300 mg 3 times a day for primary biliary cirrhosis, metoprolol (METOPROLOL) 50 mg once a day orally for high blood pressure, amlodipine (AMLODIPINE) 5mg once a day for high blood pressure and water pill for high blood pressure. The patient historical vaccine included first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration as single dose for covid-19 immunisation and experienced tiredness for quite number of days. On an unspecified date in 2021, the day after the vaccination patient had slight fever, temperature. The patient did not feel good and area where she had vaccination, underneath it was kind of red but it was not warm or anything. The patient felt terribly tired for about 10 days. The patient did not receive treatment for events. The patient stated still not experiencing events and improved. The patient informed that she had no lab tests lately. The outcome of the events was recovered on 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, Swelling of eyelid
Clinical narrative: Runny nose; right eye lid is swollen; This is a spontaneous report from a contactable consumer (parent). A 16-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 12Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated her son received his first Pfizer vaccine last Monday (12Apr2021). And he woke up yesterday (19Apr2021) and his right eye lid is swollen and today (20Apr2021) they are swollen much more and he also have a running nose. The reporter was not worry about runny nose because it was usual for him, the reporter had seen it was a side effect reporter can't find anything about the eye lid being swollen because dramatically there was no information about the vaccine but it was 7 days after he got the vaccine and he never had this problem before. So reporter was just wondering if that is listed somewhere side effects or the side effects are very rare or what was that. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Impaired healing, Scratch
Clinical narrative: Getting scratches and not healed up; Getting scratches and not healed up; Some blood coming in urine; This is a spontaneous report from a contactable consumer (reporting for husband). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 10Apr2021 (Lot Number: EW0150; Expiration Date: Jul2021) as single dose for covid-19 immunisation. Patient History and Investigation Assessment were reported as none. Concomitant medications were not reported. The patient got his first Pfizer dose for Covid on 10Apr2021 which was on Saturday and after that like another 24 hours after his first dose. He had some blood coming in his urine. It was not too much; it was less but it was there. At least for 24 hours or may be 26 hours. It was 10Apr2021 only. Like he got his vaccine in the afternoon and towards the evening he noticed that. He had beet root also that afternoon like it might and also not sure if that was the thing. But he saw that in the evening and approximately in the night and then next morning it was fine. After that he did not had any issues but he was getting a lot of scratches even if his daughter scratches him he was getting a scratch and that was not getting healed up. It had been like two days he had got a scratch and that was not getting healed up that was they got a little worried. No treatment was received for events. They were wondering if they need to go and get any blood work done before the second dose because he would have his second Pfizer dose on 28th. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: On the first dose she received just a sore arm and mild headache; On the first dose she received just a sore arm and mild headache; This is a spontaneous report received from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Lot Number: EN6208), dose 1 via an unspecified route of administration, administered in Arm Left on 21Mar2021 16:45 as a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After the first dose, she received just a sore arm and mild headache, both on an unspecified date in 2021. The outcome of events was unknown.    No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Insomnia, Muscle swelling, Myalgia, Swelling
Clinical narrative: slightly more swelling about just it hot; slightly more swelling about just it hot; muscle pain from another shot was given in right arm through the armpit to the right boob; muscle swelling; was difficult to sleep; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of  bnt162b2 (BNT162B2, Lot Number: EW0162), via an unspecified route of administration on 15Apr2021 08:45 as single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had no other products. The patient previously received first dose of bnt162b2 (lot number: ER8733, expiration date: 31Jul2021) on 25Mar2021 08:30 for covid-19 immunisation, and experienced 3 inch diameter of a red hot slightly swollen area last for about 3 days. The second shot 3 weeks later and same reaction slightly more swelling about just it hot but it lasted almost 5 days. However, with the second shot she had a muscle pain from another shot was given in right arm through the armpit to the right boob and now, she had been subsided until today which was almost day 6th and it was terrible that pain in the muscle swelling was just the first two days was difficult to sleep and she was just curious if anyone else has this muscle pain that from the short area through the armpit in to the right chest area in to the right boob. Treatment received Tylenol and Ibuprofen for the pain from second shot. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: 3 inch diameter of a red hot slightly swollen area; 3 inch diameter of a red hot slightly swollen area; 3 inch diameter of a red hot slightly swollen area; This is the spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (Batch/Lot Number: ER8733; Expiration Date: 31Jul2021), via an unspecified route of administration on 25Mar2021 08:30 as single dose for covid-19 immunization. The patient had no medical history. The patient had no other products. The patient experienced 3 inch diameter of a red hot slightly swollen area in Mar2021. It had like a 3-inch diameter of a red hot slightly swollen area, the first shot last it for about 3 days. The outcome of events was resolved.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Headache; Tired; During the night, around 1 or 2 am, she couldn't lift her arm.; Arm, achy and sore, struggle to reach with her arm; Dry cough in the evening, not normal; Injection site pain, left arm; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left at 09:40 on 09Apr2021 (Batch/Lot Number: EW0151) as single dose for COVID-19 immunization. Medical history reported as none. The patient's concomitant medications were not reported. The patient previously took BNT162B2, dose 1 via an unspecified route of administration, administered in right upper arm at 11:30 am on 19Mar2021 (Batch/Lot Number: ER2613) for COVID-19 immunization and experienced slightly sore right arm. The patient experienced dry cough in the evening, not normal on 09Apr2021, injection site pain, left arm on 09Apr2021, arm, achy and sore, struggle to reach with her arm at 09:55 on 09Apr2021, headache at 02:00 on 10Apr2021, tired at 02:00 on 10Apr2021, during the night, around 1 or 2 am, she couldn't lift her arm on 10Apr2021. Therapeutic measures were taken as a result of events injection site pain, left arm and arm, achy and sore, struggle to reach with her arm and headache. The outcome of event injection site pain, left arm was recovering; of event couldn't lift her arm was unknown; of event headache was recovered on 10Apr2021; of event tired was recovered on 14Apr2021; of rest events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Headache; Tired; During the night, around 1 or 2 am, she couldn't lift her arm.; Arm, achy and sore, struggle to reach with her arm; Dry cough in the evening, not normal; Injection site pain, left arm; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left at 09:40 on 09Apr2021 (Batch/Lot Number: EW0151) as single dose for COVID-19 immunization. Medical history reported as none. The patient's concomitant medications were not reported. The patient previously took BNT162B2, dose 1 via an unspecified route of administration, administered in right upper arm at 11:30 am on 19Mar2021 (Batch/Lot Number: ER2613) for COVID-19 immunization and experienced slightly sore right arm. The patient experienced dry cough in the evening, not normal on 09Apr2021, injection site pain, left arm on 09Apr2021, arm, achy and sore, struggle to reach with her arm at 09:55 on 09Apr2021, headache at 02:00 on 10Apr2021, tired at 02:00 on 10Apr2021, during the night, around 1 or 2 am, she couldn't lift her arm on 10Apr2021. Therapeutic measures were taken as a result of events injection site pain, left arm and arm, achy and sore, struggle to reach with her arm and headache. The outcome of event injection site pain, left arm was recovering; of event couldn't lift her arm was unknown; of event headache was recovered on 10Apr2021; of event tired was recovered on 14Apr2021; of rest events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Slightly sore right arm after first vaccine; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 65 years old, administered in arm right on 19Mar2021 11:30 (Lot Number: ER2613) at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced slightly sore right arm after first vaccine on 19Mar2021, it started 15 minutes after the injection. The outcome of the event was recovered in 2021.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Dizziness, Gingival discomfort, Headache
Clinical narrative: Muscle pain; Headache; I think my neck was little bit swollen; swollen lymph nodes; Dizziness; I had a little bit of fast heart beat; Pain from my neck and nose almost like a slight discomfort through my gums like a toothache; Pain from my neck and nose almost like a slight discomfort through my gums like a toothache; Pain from my neck and nose almost like a slight discomfort through my gums like a toothache; Pain from my neck and nose almost like a slight discomfort through my gums like a toothache; whatever was happening was going through my whole left side it feels like something is wrong/slight discomfort still; severe pain around the upper shoulder like almost connected to the neck little bit and that's really painful right now; Little bit congested through my side of my head a little bit, back of my head cheeks area a little bit; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EW0158, patient didn't know if its O or 0), via an unspecified route of administration on 11Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was wondering if side effects that patient was experiencing, still experiencing if they went away and should patient still go ahead and take the follow up vaccine shot or not. Patient experienced muscle pain, headache, patient thought his/her neck was little bit swollen, swollen lymph nodes, patient had dizziness and just for a short while had a little bit of fast heart beat but that went away right away. Patient thought that's pretty much and that's some of the side effects, and like few more like swelling like the pain from patient's neck and nose almost like a slight discomfort through gums like a toothache and stuff and whatever was happening was going through whole left side it felt like something was wrong. It was lot worse but now today (20Apr2021) its really probably severe pain around the upper shoulder like almost connected to the neck little bit and that's really painful right now and then patient could feel slight discomfort like through like a little bit congested through his/her side of head a little bit, back of head cheeks area a little bit. Patient could feel slight discomfort still but had nothing major that patient didn't think. Patient feel better than it was couple of days before. All events happened in Apr2021. Date for the second shot was scheduled on 02May2021. The outcome of events dizziness and fast heart beat was recovered in Apr2021; discomfort and 'little bit congested through head' was recovering; outcome of the other events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Lymphadenopathy, Myalgia, Neck pain
Clinical narrative: Muscle pain; Headache; I think my neck was little bit swollen; swollen lymph nodes; Dizziness; I had a little bit of fast heart beat; Pain from my neck and nose almost like a slight discomfort through my gums like a toothache; Pain from my neck and nose almost like a slight discomfort through my gums like a toothache; Pain from my neck and nose almost like a slight discomfort through my gums like a toothache; Pain from my neck and nose almost like a slight discomfort through my gums like a toothache; whatever was happening was going through my whole left side it feels like something is wrong/slight discomfort still; severe pain around the upper shoulder like almost connected to the neck little bit and that's really painful right now; Little bit congested through my side of my head a little bit, back of my head cheeks area a little bit; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EW0158, patient didn't know if its O or 0), via an unspecified route of administration on 11Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was wondering if side effects that patient was experiencing, still experiencing if they went away and should patient still go ahead and take the follow up vaccine shot or not. Patient experienced muscle pain, headache, patient thought his/her neck was little bit swollen, swollen lymph nodes, patient had dizziness and just for a short while had a little bit of fast heart beat but that went away right away. Patient thought that's pretty much and that's some of the side effects, and like few more like swelling like the pain from patient's neck and nose almost like a slight discomfort through gums like a toothache and stuff and whatever was happening was going through whole left side it felt like something was wrong. It was lot worse but now today (20Apr2021) its really probably severe pain around the upper shoulder like almost connected to the neck little bit and that's really painful right now and then patient could feel slight discomfort like through like a little bit congested through his/her side of head a little bit, back of head cheeks area a little bit. Patient could feel slight discomfort still but had nothing major that patient didn't think. Patient feel better than it was couple of days before. All events happened in Apr2021. Date for the second shot was scheduled on 02May2021. The outcome of events dizziness and fast heart beat was recovered in Apr2021; discomfort and 'little bit congested through head' was recovering; outcome of the other events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rhinalgia, Swelling, Toothache, Upper respiratory tract congestion
Clinical narrative: Muscle pain; Headache; I think my neck was little bit swollen; swollen lymph nodes; Dizziness; I had a little bit of fast heart beat; Pain from my neck and nose almost like a slight discomfort through my gums like a toothache; Pain from my neck and nose almost like a slight discomfort through my gums like a toothache; Pain from my neck and nose almost like a slight discomfort through my gums like a toothache; Pain from my neck and nose almost like a slight discomfort through my gums like a toothache; whatever was happening was going through my whole left side it feels like something is wrong/slight discomfort still; severe pain around the upper shoulder like almost connected to the neck little bit and that's really painful right now; Little bit congested through my side of my head a little bit, back of my head cheeks area a little bit; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EW0158, patient didn't know if its O or 0), via an unspecified route of administration on 11Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was wondering if side effects that patient was experiencing, still experiencing if they went away and should patient still go ahead and take the follow up vaccine shot or not. Patient experienced muscle pain, headache, patient thought his/her neck was little bit swollen, swollen lymph nodes, patient had dizziness and just for a short while had a little bit of fast heart beat but that went away right away. Patient thought that's pretty much and that's some of the side effects, and like few more like swelling like the pain from patient's neck and nose almost like a slight discomfort through gums like a toothache and stuff and whatever was happening was going through whole left side it felt like something was wrong. It was lot worse but now today (20Apr2021) its really probably severe pain around the upper shoulder like almost connected to the neck little bit and that's really painful right now and then patient could feel slight discomfort like through like a little bit congested through his/her side of head a little bit, back of head cheeks area a little bit. Patient could feel slight discomfort still but had nothing major that patient didn't think. Patient feel better than it was couple of days before. All events happened in Apr2021. Date for the second shot was scheduled on 02May2021. The outcome of events dizziness and fast heart beat was recovered in Apr2021; discomfort and 'little bit congested through head' was recovering; outcome of the other events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dizziness, Pyrexia
Clinical narrative: felt weak; dizzy; had a high temperature; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had side effects from the 1st dose so won't be able to take the 2nd dose on the 22Apr2021. It was reported 3 days after the 1st dose patient felt weak and dizzy, he had a high temperature. He's not sure if he had a virus prior to the 1st dose. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pyrexia, Vaccination site bruising
Clinical narrative: FEVER; DIDN'T FEEL GOOD; BLACK AND BLUE ARM AT INJECTION SITE; A LITTLE TIRED; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received first dose of BNT162B2 (Solution for injection; Lot number: EP2163 and expiration date was not reported) via an unspecified route of administration, as single dose for COVID-19 immunization in Apr2021. The patients medical history and concomitant medications were not reported. The patient experienced fever, did not feel good, black, and blue arm at injection site and was a little tired. Patient did miss two doses of self-due to this issue. The patient is feeling better. The outcome of the events was unknown.   No Follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: he got the shingles; This is a spontaneous report from a Pfizer Sponsored Program. A non-contactable consumer (patient's wife) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. None medical history. The patient's concomitant medications were not reported. The patient experienced shingles on an unspecified date with outcome of unknown. The reporter asked if her husband can still take his second covid vaccine on Friday since he got the shingles after getting the first covid vaccine. She clarified that the husband did not have shingles before covid vaccine.  No follow-up attempts are possible; Information related to batch/Lot number could not be requested.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Burning sensation in his feet; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 06Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced burning sensation in his feet on 17Mar2021. The outcome of the event was unknown. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 27Mar2021 at single dose for COVID-19 immunization.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Drug interaction, Myalgia, Pain, Vaccination site pain
Clinical narrative: horrendous pain in his left shoulder which is where the vaccine was given, general muscle and joint point all over; general muscle and joint point all over; general muscle and joint point all over; would like to know if there has been any possible side effects or interactions with his cardiovascular medications pravastatin sodium 40 mg and Plavix 75 mg; on day 12 he also had difficulty getting out of his car.; This is a spontaneous report from a contactable consumer (patient himself). A 83-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) on unspecified date (at the age of 83-years-old) as single dose for COVID-19 immunization. The patient received first dose of BNT162B2 for covid-19 immunization on unspecified date with no adverse effect after first dose. Medical history included injury to shoulder. Concomitant medications included Pravastatin Sodium and Plavix for cardiovascular . Patient received both doses of the Pfizer COVID vaccine. Caller states the second dose was given approximately three and a half weeks ago. Caller would like to know if there has been any possible side effects or interactions with his cardiovascular medications pravastatin sodium 40 mg and Plavix 75 mg. He stated that he had a response to the pravastatin sodium 6 years ago where he had similar side effects to what he was experiencing now. He had no reaction to the vaccine during the waiting period at the vaccination facility. He stated that 10 days after receiving the vaccine he woke up with horrendous pain in his left shoulder which was where the vaccine was given. He also had general muscle and joint point all over. He stated that the pain in his shoulder was improving but was still present and he was unable to put on a coat or lift his shoulder and on day 12 he also had difficulty getting out of his car. The outcome of events was unknown and outcome of the event horrendous pain in his left shoulder which was where the vaccine was given, general muscle and joint point all over was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Magnetic resonance imaging, Mobility decreased, Movement disorder
Clinical narrative: horrendous pain in his left shoulder which is where the vaccine was given, general muscle and joint point all over; general muscle and joint point all over; general muscle and joint point all over; would like to know if there has been any possible side effects or interactions with his cardiovascular medications pravastatin sodium 40 mg and Plavix 75 mg; on day 12 he also had difficulty getting out of his car.; This is a spontaneous report from a contactable consumer (patient himself). A 83-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) on unspecified date (at the age of 83-years-old) as single dose for COVID-19 immunization. The patient received first dose of BNT162B2 for covid-19 immunization on unspecified date with no adverse effect after first dose. Medical history included injury to shoulder. Concomitant medications included Pravastatin Sodium and Plavix for cardiovascular . Patient received both doses of the Pfizer COVID vaccine. Caller states the second dose was given approximately three and a half weeks ago. Caller would like to know if there has been any possible side effects or interactions with his cardiovascular medications pravastatin sodium 40 mg and Plavix 75 mg. He stated that he had a response to the pravastatin sodium 6 years ago where he had similar side effects to what he was experiencing now. He had no reaction to the vaccine during the waiting period at the vaccination facility. He stated that 10 days after receiving the vaccine he woke up with horrendous pain in his left shoulder which was where the vaccine was given. He also had general muscle and joint point all over. He stated that the pain in his shoulder was improving but was still present and he was unable to put on a coat or lift his shoulder and on day 12 he also had difficulty getting out of his car. The outcome of events was unknown and outcome of the event horrendous pain in his left shoulder which was where the vaccine was given, general muscle and joint point all over was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Physical examination abnormal
Clinical narrative: horrendous pain in his left shoulder which is where the vaccine was given, general muscle and joint point all over; general muscle and joint point all over; general muscle and joint point all over; would like to know if there has been any possible side effects or interactions with his cardiovascular medications pravastatin sodium 40 mg and Plavix 75 mg; on day 12 he also had difficulty getting out of his car.; This is a spontaneous report from a contactable consumer (patient himself). A 83-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) on unspecified date (at the age of 83-years-old) as single dose for COVID-19 immunization. The patient received first dose of BNT162B2 for covid-19 immunization on unspecified date with no adverse effect after first dose. Medical history included injury to shoulder. Concomitant medications included Pravastatin Sodium and Plavix for cardiovascular . Patient received both doses of the Pfizer COVID vaccine. Caller states the second dose was given approximately three and a half weeks ago. Caller would like to know if there has been any possible side effects or interactions with his cardiovascular medications pravastatin sodium 40 mg and Plavix 75 mg. He stated that he had a response to the pravastatin sodium 6 years ago where he had similar side effects to what he was experiencing now. He had no reaction to the vaccine during the waiting period at the vaccination facility. He stated that 10 days after receiving the vaccine he woke up with horrendous pain in his left shoulder which was where the vaccine was given. He also had general muscle and joint point all over. He stated that the pain in his shoulder was improving but was still present and he was unable to put on a coat or lift his shoulder and on day 12 he also had difficulty getting out of his car. The outcome of events was unknown and outcome of the event horrendous pain in his left shoulder which was where the vaccine was given, general muscle and joint point all over was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Pyrexia
Clinical narrative: Fever; I feel like spaced out; "brain fog"; Breathing is more labored; This is a spontaneous report from a contactable consumer (patient). A 67-years-old-female patient received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot number was not reported) first dose via unspecified route of administration on 23Apr2021 as single dose for COVID-19 immunization. the patient medical history including End stage COPD. The patient concomitant medications were not reported. Patient stated, that she had end stage COPD. she received her Pfizer shot yesterday first dose. she know had fever was normal. she feel like spaced out; "brain fog". Patient breathing was more labored. she supposed to feel this way. Her son (age: 34 now but when he wasn't walking yet) received the DPT shot and reacted and almost died from it. He was laying there blue." As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with your doctor/healthcare provider about what you have experienced/are experiencing. The outcome of the events was unknown.  e-transmitting for caller and son (non Pfizer AE). Caller did not want to be transferred to safety at the time of the call (7 callers ahead).  can contact caller if needed.  Response: Spoke from EUA PI (LAB-1457-7.0 Revised: 06Apr2021) under section 6 OVERALL SAFETY SUMMARY   Emailed "how long side effects last" as requested  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: had moderate menstrual bleeding which started shortly after receiving second dose/The bleeding continues daily; This is a spontaneous report from a contactable nurse (patient). This 44-year-old female nurse received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration, administered in Arm Left on 03Feb2021 18:00 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included IUD from an unknown date and unknown if ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 06Jan2021 at 06:00 PM on left arm. Patient did not have COVID-19 prior to vaccination.  Concomitant medication(s) included lisdexamfetamine mesilate (VYVANSE) 40mg qd (once a day) taken for an unspecified indication, start and stop date were not reported.  The patient reported that she "had moderate menstrual bleeding which started shortly after receiving second dose" and "the bleeding continues daily" on 05Feb2021 18:00 with outcome of not recovered. Patient was not tested for COVID-19 post vaccination.   Information on the lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Pruritus, Rash, SARS-CoV-2 test
Clinical narrative: Redness; Itching; Rash; Wondering if an allergic reaction; The vaccine injection site started to itch; hives all over the body; Hives appeared around the vaccine injection site; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ep7533), dose 1 via an unspecified route of administration, in right arm on 07Apr2021 12:00 (at 30-years age) as single dose for covid-19 immunisation. The patient relevant past drug history includes allergic to contrast IV Iodine and wheat. The patient's concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19. The vaccine injection site started to itch within 5 minutes after vaccination and hives all over the body on 07Apr2021 12:14. Hives appeared around the vaccine injection site within 10 minutes on 07Apr2021 12:10. Patient left the pharmacy without notification of reaction after 14 minutes. Continued to developed hives all over the body that came and went for approximately 2 weeks after receiving the vaccine. Patient was getting hives and redness around the itching rash; patient was asking if it was normal for all. Patient was wondering if it was an allergic reaction. Since the vaccination, the patient not tested for COVID-19. The outcome of the events was unknown.  Communication: Reason of delay: Daily spike of incoming calls due to COVID19 vaccine.  No follow-up attempts are needed. No further information is expected.