chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Fatigue, Feeling abnormal, Headache, Illness
Clinical narrative: I couldn't think straight; It went to the front of my head; Headache; Extreme fatigue; My arm hurt for almost 12 hours but this thing went in to my neck; My arm hurts and it was very bad; arm hurt for almost 12 hours but this thing went in to my muscles; This is terrible; Got so sick; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 28Jul2021 (vaccinated at the age of 58-years) as dose 1, single for Covid-19 immunisation. Medical history included none. There were no concomitant medications. The patient reported as "my arm hurts and it was very bad on 28Jul2021, arm hurt for almost 12 hours but this thing went in to my muscles in 2021, i couldn't think straight; it went to the front of my head on an unspecified date, headache and extreme fatigue on 30Jul2021, this is terrible and got so sick in 2021, my arm hurt for almost 12 hours but this thing went in to my neck on 29Jul2021". It was reported by patient that she took the first Pfizer, she didn't want to take it but she went to take it and she would not taking the second one. she got so sick from that shot, her arm hurts but she have no problem she don't care if her arm hurt for almost 12 hours but this thing went in to her neck, her muscles, she couldn't move her neck for about two or three days, came up to her head and she couldn't think straight and it went to the front of her head, she have headache and she was really upset with this. Also extreme fatigue as well. So, her arm hurts, Wednesday night on 28th at night as expected, as she said, her arm hurts and it was very bad but that is okay and then by Thursday, until the next day about 24 hours later, that is when it started with her neck for about 2 or 3 days and Friday, Saturday, Sunday was the headache and fatigue. Still experiencing events: Consumer stated that the neck was better, still getting headache, she do have some fatigue but she went for 2 hours massage as well. Treatment: Consumer stated, "Aspirin just like two Aspirin, two Aspirin and two Ibuprofen, two Ibuprofen, she meant altogether will be 8 (further clarification about the medications was unknown). "Therapeutic measures were taken as a result of arm pain, myalgia, headache and neck pain. No lab work was reported and her family doctor told her that she was at risk with this shot. Consumer stated, "So, they are going to improve it for next 'guinea pig' really she mean was glad because when there was lawsuit she had it documented that she called in, really this was terrible." Outcome of Headache, extreme fatigue was not resolved; neck pain was resolving and for other events outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Pain in extremity
Clinical narrative: I couldn't think straight; It went to the front of my head; Headache; Extreme fatigue; My arm hurt for almost 12 hours but this thing went in to my neck; My arm hurts and it was very bad; arm hurt for almost 12 hours but this thing went in to my muscles; This is terrible; Got so sick; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 28Jul2021 (vaccinated at the age of 58-years) as dose 1, single for Covid-19 immunisation. Medical history included none. There were no concomitant medications. The patient reported as "my arm hurts and it was very bad on 28Jul2021, arm hurt for almost 12 hours but this thing went in to my muscles in 2021, i couldn't think straight; it went to the front of my head on an unspecified date, headache and extreme fatigue on 30Jul2021, this is terrible and got so sick in 2021, my arm hurt for almost 12 hours but this thing went in to my neck on 29Jul2021". It was reported by patient that she took the first Pfizer, she didn't want to take it but she went to take it and she would not taking the second one. she got so sick from that shot, her arm hurts but she have no problem she don't care if her arm hurt for almost 12 hours but this thing went in to her neck, her muscles, she couldn't move her neck for about two or three days, came up to her head and she couldn't think straight and it went to the front of her head, she have headache and she was really upset with this. Also extreme fatigue as well. So, her arm hurts, Wednesday night on 28th at night as expected, as she said, her arm hurts and it was very bad but that is okay and then by Thursday, until the next day about 24 hours later, that is when it started with her neck for about 2 or 3 days and Friday, Saturday, Sunday was the headache and fatigue. Still experiencing events: Consumer stated that the neck was better, still getting headache, she do have some fatigue but she went for 2 hours massage as well. Treatment: Consumer stated, "Aspirin just like two Aspirin, two Aspirin and two Ibuprofen, two Ibuprofen, she meant altogether will be 8 (further clarification about the medications was unknown). "Therapeutic measures were taken as a result of arm pain, myalgia, headache and neck pain. No lab work was reported and her family doctor told her that she was at risk with this shot. Consumer stated, "So, they are going to improve it for next 'guinea pig' really she mean was glad because when there was lawsuit she had it documented that she called in, really this was terrible." Outcome of Headache, extreme fatigue was not resolved; neck pain was resolving and for other events outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: pain all across her arm, wrist and palm (as the same side as the injection).; pain all across her arm, wrist and palm (as the same side as the injection).; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 32-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; #lot Number: FA7485) via an unspecified route of administration, administered in arm on 08Aug2021 (at the age of 32-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On unknown date, the patient experienced pain all across her arm, wrist and palm. The patient started experiencing pain all across her arm, wrist and palm (as the same side as the injection). The patient's husband asked if this normal and then clarified that the pain is in the arm, not in the area of the injection site. After that wife asked if the Pfizer covid 19 vaccine was experimented on people of color. The reason she was experiencing this particular side effect was because there was such a low number of those in her race profile. She said, her relatives who took other vaccines in India did not experience this and also the patient inquired that if it was okay to take only one dose of the Pfizer covid 19 vaccine. On an unspecified date, the patient started experiencing pain in rest part of the arm except where she got injected. The patient's husband stated that his wife took the first Pfizer vaccine shot that day, a few hours earlier. So, what was normal he has heard was, the side effect as the little bit of soreness in the arm in the area where the injection was given but for her, she was experiencing pain in rest part of the arm except where she got injected. So, it was a little bit weird, that was why she reported. The outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Goitre, Heavy menstrual bleeding, Increased tendency to bruise, White blood cell count decreased
Clinical narrative: WBC is low/White blood cell count low; she got an unusual heavy period; thyroid is enlarged; bruises easily; This is a spontaneous report from a contactable consumer (parent). A 18-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Jul2021 as dose 1, single for covid-19 immunisation. The patient Medical history was none. The patient's concomitant medications. Caller stated that She got her first shots 3 weeks ago and second one was due today. Her daughter had gotten an unusually heavy period after the first one. Her biggest concern was that she went to her normal check up with her nurse practitioner and her thyroid is enlarged. Her doctor said it was noted before now and that she bruises easily. She got a blood test done and her white blood cell count is low. The patient did not visit to Emergency Room or Physician Office. The patient underwent lab tests and procedures which included blood test: low white blood cell count on unknown date. The outcome of the events was unknown.    This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nervousness
Clinical narrative: did not get my 2nd shot; made me nervous; This is a spontaneous report from a contactable consumer (patient. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: not reported, Expiration date: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history included COVID-19 on an unspecified date in Mar2021. Concomitant medications were not reported. On an unspecified date in Apr2021, patient stated any of the my refrigerator magnets would stick to my injection site for up to 72 hours, it made me nervous so I did not get my 2nd shot. Patient also reported any of the my refrigerator magnets would stick to my injection site for up to 72 hours. What is in the vaccine that makes it stick to her arm?. Will I be sicker with it because I have gone past the 3-6 week period?" Is there any information on magnetic effects at the injection site after receiving vaccination with the Pfizer-BioNTech COVID-19 vaccine. It was reported that We are not aware of any properties of the content of the vaccine that would suggest magnetic effects at the site of injection. In fact, the U.S. Centers for Disease Control and Prevention  has specifically stated that all COVID-19 vaccines are free from metals such as iron, nickel, cobalt, lithium, rare earth alloys or any manufactured products such as microelectronics, electrodes, carbon nanotubes, or nanowire semiconductors. As of 30Apr2021, a search of our safety surveillance database for Pfizer-BioNTech COVID-19 vaccine revealed no spontaneous reports of magnetic properties at injection site since the market introduction (including emergency use authorization) of Pfizer-BioNTech COVID-19 vaccine. Also, a search of the published medical literature on 19May2021 failed to identify relevant information on this topic. Therefore, we are not aware of any information regarding events of magnetic effects at the site of injection. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia, Vision blurred
Clinical narrative: I also has blurred vision; Tingling in my legs, arms and feet and its persistent/They are tingling like pins and needles; This is a spontaneous report from contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FA6780, Expiration date: Unknown), via an unspecified route of administration on 05Aug2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On Aug2021, the patient experienced I am experiencing today and through the night is tingling in my legs, arms and feet and it's persistent; I also has blurred vision; they are tingling like pins and needles. Consumer stated he has blurred vision was that something normal or do he need to seek medical attention immediately or what was that. When paraphrased above concern, Consumer stated, they are tingling like pins and needles, do you understand that, exactly yes. Consumer stated, So they are closed today and tomorrow, what do I do, how would I know if need go and seek medical attention immediately or I should wait, if I really go to the hospital for something if I know that emergency. When probed for the concern, caller stated, "I had already called someone (Pfizer Drug Safety) to report an adverse side effect. The clinical outcome of events blurred vision was unknown and outcome of other event Paraesthesia was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity, Pyrexia, Swelling
Clinical narrative: aching; Fever; Growing and swelling up; Real bad pain into my arm and into my neck and they are so, sore; Real bad pain into my arm and into my neck and they are so, sore; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient) reporting for herself. This female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0186, expiration date: unknown), via an unspecified route administered in left upper arm on 16Jul2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that she took second COVID shot past Friday, the first one she took on the 16Jul2021 and that she already had COVID back in March and she told that I would probably have lot of symptoms with the first one but not with second one. We have both of them I mean I felt worst when I had the COVID I was aching, fever, growing and swelling up. The second one actually the symptoms came out a lot faster with second one but, because the first shot it was the next day when I started feeling the side effects, with the second shot I started feeling them within hours, I have got, my fever is gone and all that, but I have still got a real bad pain into my arm and into my neck and they are so, sore, and I don't know if that is normal'. The outcome of event aching is unknown, Fever, Growing and swelling up is recovered on an unspecified date in 2021 and real bad pain into my arm and into my neck and they are so, sore is not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: My heart was racing; This is a spontaneous report from a contactable Consumer. This Consumer reported that:  A patient of unspecified age and gender received BNT162B2 (Comirnaty, Formulation: Solution for injection, Batch/lot number: Unknown, Expiry Date of Unspecified Vaccine: Unknown) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date patient heart was racing (I 'only got the vaccine (Unspecified Vaccine) on Saturday and ever since Saturday I was having like my heart was racing. I was like I do not know (incomplete sentence). When again probed for the concern, Patient stated, "Is there anyone else I could speak to, maybe there is a language barrier, I think that is what the issue is. I can hear you. I asked if there is someone I can speak to where there is no language barrier. I was telling you something and you cannot understand me and you still cannot understand me. So is there anyone that I can speak to where there's not a language barrier. Limited information was available over the call. The clinical outcome event was unknown  Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: racing of the heart; This is a spontaneous report from a contactable consumer, reported for a 63-year-old female patient. A 63-year-old female patient received BNT162B2( PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Mar2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient has experienced racing of the heart (palpitations) on 2021. Clinical course of events includes; stated that, she has to report her racing of the heart. States that she didn't put 2 and 2 together, and that this has been waking her up at night. Has been occurring since Mar when she got the vaccine. She states that she has noticed it got more intense; now is calming down again. Asked, is that normal, as she says she couldn't figure out what was happening, that it was more intense and faster. Reports that it just sped up like it would be irregular and then continue beating really fast. She is hoping this week she can see if they (HCP) can figure something out. Also asked that, her 17 year old nephew, who received his last dose of the Pfizer BioNTech Covid-19 vaccine on 07Aug2021. 18 hours after, he took ibuprofen, and she is asking if that was ok to do. The outcome for the event palpitations was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Limb injury
Clinical narrative: stubbed toe; experiencing aches; feeling miserable and crummy; having colds; chills that have been persisting; headache; feeling tired; This is a spontaneous report from a contactable consumer or other non hcp. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FC3180; Expiration Date: 30Oct2021), dose 1 via an unspecified route of administration, administered in Deltoid Left on 07Aug2021 (at the age of 70-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included nausea from Jul2021 to an unknown date, gastrooesophageal reflux disease from 2020 to an unknown date, irritable bowel syndrome from 2020 to an unknown date, gastrointestinal disorder from an unknown date. Concomitant medication included dicyclomine taken for an unspecified indication; pantoprazole taken for dyspepsia; acyclovir [aciclovir] taken for herpes virus infection; bupropion taken for depression; buspirone taken for anxiety, all from an unspecified start date and ongoing. The patient experienced aches, feeling miserable and crummy, having colds, chills that have been persisting and headache on 08Aug2021, feeling tired, stubbed toe on 10Aug2021. Patient reported that she had the vaccination on Saturday 7Aug2021 and she felt okay. But then on Sunday morning she was aching all over and felt miserable. Mentions the next day, Monday, she had to go to the eye doctor and was feeling pretty good; but that afternoon she felt crummy again with cold chills. Today she is still feeling crummy this morning. She is asking what was the average time for the side effect to go away? Adds she has the drapes closed because she was tired and also she has had a headache that comes and goes. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain
Clinical narrative: stubbed toe; experiencing aches; feeling miserable and crummy; having colds; chills that have been persisting; headache; feeling tired; This is a spontaneous report from a contactable consumer or other non hcp. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FC3180; Expiration Date: 30Oct2021), dose 1 via an unspecified route of administration, administered in Deltoid Left on 07Aug2021 (at the age of 70-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included nausea from Jul2021 to an unknown date, gastrooesophageal reflux disease from 2020 to an unknown date, irritable bowel syndrome from 2020 to an unknown date, gastrointestinal disorder from an unknown date. Concomitant medication included dicyclomine taken for an unspecified indication; pantoprazole taken for dyspepsia; acyclovir [aciclovir] taken for herpes virus infection; bupropion taken for depression; buspirone taken for anxiety, all from an unspecified start date and ongoing. The patient experienced aches, feeling miserable and crummy, having colds, chills that have been persisting and headache on 08Aug2021, feeling tired, stubbed toe on 10Aug2021. Patient reported that she had the vaccination on Saturday 7Aug2021 and she felt okay. But then on Sunday morning she was aching all over and felt miserable. Mentions the next day, Monday, she had to go to the eye doctor and was feeling pretty good; but that afternoon she felt crummy again with cold chills. Today she is still feeling crummy this morning. She is asking what was the average time for the side effect to go away? Adds she has the drapes closed because she was tired and also she has had a headache that comes and goes. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Neuralgia, Oral discomfort, Pain in extremity
Clinical narrative: burning pain in the mouth 7 hours after getting vaccinated and burning pain in the arm and the leg that felt like nerve pain after a couple of weeks post-vaccination; burning pain in the mouth 7 hours after getting vaccinated and burning pain in the arm and the leg that felt like nerve pain after a couple of weeks post-vaccination; burning pain in the mouth 7 hours after getting vaccinated and burning pain in the arm and the leg that felt like nerve pain after a couple of weeks post-vaccination; burning pain in the mouth 7 hours after getting vaccinated and burning pain in the arm and the leg that felt like nerve pain after a couple of weeks post-vaccination; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2 Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced burning pain in the mouth 7 hours after getting vaccinated and burning pain in the arm and the leg that felt like nerve pain after a couple of weeks post-vaccination  on an unspecified.  The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Crying, Pain, Speech disorder
Clinical narrative: Excruciating stomach pain/Horrific pain; Excruciating stomach pain/Horrific pain; She can barely speak; Crying; This is a spontaneous report from a contactable consumer. A 19-year-old female patient (reporter's daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was unknown), via an unspecified route of administration on an unspecified date as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was unknown), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. Stated that, the reporter called about 19-year-old daughter and stated that, she's there with the reporter in the bedroom. The reporter's daughter was the one who got the shot (Unspecified Vaccine). Stated that, the reporter's daughter had her second Pfizer shot yesterday afternoon on an unspecified date and she was in excruciating stomach pain. Stated that, the reporter don't even know what to say about that, it's just, she was right there, the reporter mean she can barely speak, she's crying, she was in horrific pain. Stated that, the reporter don't know what to do with her. The reporter means that, she's an adult she turned to get her shot to get back on college campus and the reporter was not sure how to handle this. Stated that, the reporter mean need to take her to the emergency room, what did the reporter did. The reporter was informed about the role of Pfizer Drug Safety and was also informed about Pfizer Medical Information and offered the number. Stated that, the reporter don't know because the reporter have half an hour probably, the reporter mean to take her to emergency room, so the reporter mean will write it down. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report from a program. A contactable consumer (patient) reported that a 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 27Jan2021 (Batch/Lot number: EL926S, as reported) (at the age of 68 years old) as dose 1, single; and via an unspecified route of administration, administered in right arm on 04Mar2021 (Batch/Lot Number: EN6206) (at the age of 68 years old) as dose 2, single for COVID-19 immunisation. Medical history included kidney transplant performed on 29Dec2015, ongoing diabetes, and hypertension (both diagnosed about 15 years ago). There were no concomitant medications. No prior vaccinations (within 4 weeks). The patient experienced fully vaccinated and admitted to the hospital with COVID-19 on 17Jul2021, she received her Pfizer-Biontech COVID-19 vaccine doses in Jan2021 and Feb2021. She reported a history of COVID infection on 17Jul2021. The patient was hospitalized from 17Jul2021 to 21Jul2021 for 4 days. The patient stated that she was treated with an infusion that she can't pronounce. Event required a visit to Emergency Room and Physician Office. She and her husband were both fully vaccinated and admitted to the hospital with COVID-19. She was admitted for about 4 days and her husband, who had several symptoms, was in the hospital for about 3 weeks. She presented to her local pharmacy, yesterday, for the 'booster dose' but was denied. The pharmacist told her she had to wait 90 days after the infusion. She wanted to know why and when can she get her booster dose. The patient underwent lab tests and procedures which included COVID-19 test positive on 17Jul2021. The outcome of the event was recovered in Jul2021. On 17Aug2021, additional information from product quality included 17Aug2021 11:36 AM added ID-052326. Based on reporter providing lot number as EL926S it is not clear if the lot number is one of the ones provided above or EL9265. Added lot number EN6206 to product grid above. 17Aug2021 11:15 AM added ID-052326: Duplicate received in ID 6240336: Description of complaint: Hospitalized with Covid 19 after both doses of Pfizer Covid 19 Vaccine. Additional lot numbers: EL926S, documented as provided by the caller, EN6206. Processing for additional lot number provided in duplicate. Added AER#.16Aug2021 05:17 PM initial Product Name: Pfizer Covid 19 Vaccine NDC Number: Not Provided. COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1 Lot # EL9262 (as reported)".  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: received her first dose of the Pfizer Covid-19 Vaccine 2 weeks ago.  She tested positive for COVID-19 last week; This is a spontaneous report from a contactable pharmacist. A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient is not on any medications or have any medical conditions that the reporter is aware of. The reporter does not know if the patient had any other shots on the day she got the Covid vaccine. The patient experienced received her first dose of the pfizer covid-19 vaccine 2 weeks ago. she tested positive for covid-19 last week on an unknown date in Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unknown date in Aug2021. Outcome of the event was not recovered.  Information about lot/batch number has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Tested postitive for COVID virus; Tested postitive for COVID virus; This is a spontaneous report from a contactable consumer. A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on 31Mar2021 (Batch/Lot number was not reported) (at the age of 49-year-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no covid prior vaccination. It was reported that the patient tested positive for covid virus on 16Aug2021 17:00 with outcome of not recovered. No treatment received for the events. The patient was covid tested post vaccination through blood test on 16Aug2021 with positive result.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Breakthrough infection of COVID-19; Breakthrough infection of COVID-19; This is a spontaneous report from a contactable physician. An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Numbers were not reported), via unspecified routes of administration, on an unspecified date, as dose 1, single, and then on 10Mar2021, as dose 2, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has received both doses of the Pfizer BioNTech COVID-19 vaccine with the second dose received 10Mar2021. However, last month (Jul2021), the patient had a breakthrough infection of COVID-19, but recovered well, physician states due to the vaccine. The physician wanted to know if getting COVID-19 again served as a booster dose and if getting the breakthrough COVID-19 infection did further increase the patient's immunity. The physician was aware that a booster dose is only currently available for patients with solid organ transplant or a similar level of immunocompromise. The patient recovered from the events in 2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events suspected COVID-19, Drug ineffective and suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin burning sensation
Clinical narrative: she had rash on the arm where she got the shot and the other arm as well/rash/Week after I got it; I broke out with rash; burning skin feeling; itching; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm on 26Jul2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in 2021 for COVID-19 immunisation. The patient stated that a week after getting the second shot (Aug2021), she had a rash on the arm where she got the shot and the other arm as well. At first it had a burning skin feeling and was itching and was nothing serious. When she took Benadryl, those went away but the rash was still there. She said she never got rashes prior to receiving the vaccine. She asked how long this would last. She wanted to know if anybody have any idea how long will the rash last or what she can do about it. She is taking Benadryl and it is not itching or burning but it was still there. The outcome of the event rash was not recovered while the outcome of the rest of the events was recovered on an unspecified date. The reporter assessed the events as non-serious.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chronic lymphocytic leukaemia, Heart rate, Investigation
Clinical narrative: raised her CLL (Chronic Lymphatic Leukemia) levels; This is a spontaneous report from a Pfizer sponsored program COVAX support, received from a contactable consumer (patient) via medical information team. A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history included irregular heartbeat for 2 years from an unknown date. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date in 2021 for COVID-19 immunization. On an unspecified date in 2021, the patient reported that she experienced irregular heartbeat, but was told by her doctor that she has had this for 2 years. The patient also reported that she had a raised CLL (chronic lymphatic leukemia) levels. The patient underwent lab tests and procedures which included heart rate: irregular   on 2021, chronic lymphatic leukemia levels: raised on 2021. The outcome of the event was unknown.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19 positive test; Covid-19 positive test; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccination included BNT162b2 given on unspecified date as dose 1, single for COVID-19 immunisation. The patient experienced COVID-19 positive test on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on unspecified date. Outcome of the 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: Choking, Cough, Drooling, Hypersensitivity, Salivary hypersecretion
Clinical narrative: Coughing related to allergies; Just more saliva than usual resulting in drool/excess moisture when coughing. (Coughing related to allergies/choking on excess saliva); Just more saliva than usual resulting in drool/excess moisture when coughing. (Coughing related to allergies/choking on excess saliva); Just more saliva than usual resulting in drool/excess moisture when coughing. (Coughing related to allergies/choking on excess saliva); Excess saliva, does not effect day to day life. Just more saliva than usual resulting in drool/excess moisture when coughing. (Coughing related to allergies/choking on excess saliva); This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient (no pregnant) received the first dose of bnt162b2 on 14Jul2021 at 13:00 (lot number: EW0198) via unknown route of administration in Left arm at single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included escitalopram oxalate (LEXAPRO); methylphenidate hydrochloride (RITALIN); prazosin; cetirizine; paracetamol (TYLENOL). Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination, and did not had covid tested post vaccination. Patient received the second dose of bnt162b2 on 04Aug2021 at 13:00 (lot number: FC3180) via unknown route of administration in Left arm for COVID-19 immunisation. On 21Jul2021, Patient experienced excess saliva, did not affect day to day life, just more saliva than usual resulting in drool/excess moisture when coughing. (Coughing related to allergies/choking on excess saliva) Patient did not receive any treatment. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fall, Hip fracture, Upper limb fracture
Clinical narrative: Broke her hip and shoulder; Broke her hip and shoulder; Fall; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on Mar2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient had a fall and broke her hip and shoulder, which ultimately put her in a rehab facility. Therapeutic measures were taken as a result of the events. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Nephrolithiasis, Pain in extremity
Clinical narrative: kidney stones; blood in the urine; her arm is a little sore; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team.   A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 16Aug2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history included kidney stones. The patient's concomitant medications were not reported.   The patient reported that she got her 1st vaccine and her arm was a little sore and they said that is normal. Caller relayed that she just went to the bathroom and there was blood in the toilet, she thought shoot she was getting kidney stones. Caller asked if vaccine side effect could be blood in the urine or kidney stones (which she has done before). The patient outcome of the events was unknown.  The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: pericarditis- inflammation in his heart; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: EM9810), via an unspecified route of administration, administered in Arm Left on 11Feb2021 11:00 (received at the age of 30-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The vaccine was administered in the hospital. The patient did not receive any other vaccines in four weeks prior to receiving BNT162B2. Medical history included Cancer, MRSA (Methicillin-resistant Staphylococcus aureus), Chemotherapy, SVT (Supraventricular tachycardia) Heart Arrhythmia X2 hospitalizations, Pericarditis, and COVID-19. The patient had no known allergies. There were no concomitant medications.  The patient went to the E.R. (emergency room) twice for pericarditis- inflammation in his heart on 21Jul2021 14:00. Therapeutic measures were taken as a result of the event which included Chochicine, Bayer Aspirin, GI Cocktail, Prilosec. Outcome of the event was not recovered. The adverse event resulted into doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient has not been tested for COVID post vaccination.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac flutter, Dyspnoea, Swelling
Clinical narrative: Have been having some heart fluttering like on the chest; Got little short of breath; Heart swelling; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified route in Jul2021 (Batch/Lot Number: EWA96) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated, "I am just calling of this number because it says that possible side effects, I have got the shot like 3 weeks ago and I am due for the second shot today (17Aug2021) but last couple of days (Aug2021) I have been having some heart fluttering like on the chest, so I don't know if I have any heart swelling or what do you call it, you know the heart, something to my heart I am not sure if it is, I have like heart fluttering, it would go away, it come back and go away like I feel like may be got little short of breath, I think that I am not sure about but I am, should I get the second shot that's what I am asking?". The patient was having heart fluttering last for 3 or 4 days but now it seemed to be going hopefully. The outcome of the event "Have been having some heart fluttering like on the chest" was recovering, of the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthma, Chest X-ray, Chest discomfort, Computerised tomogram abdomen
Clinical narrative: Cough; heaviness to the chest; Stomach pain; Coughing so much his ribs get sore; Experiencing shortness of breath together with the cough; asthma; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EW0161), via an unspecified route of administration, administered in left arm on 12May2021 13:00 (at the age of 50-year-old) as dose 2, single for COVID-19 immunization. There was no additional vaccine administered on same date of the BNT162B2. The patient did not receive any other vaccine within four weeks prior to the first administration date of the BNT162B2. Medical history included he had thyroid removed one time and it grew back and acid reflux. Family medical history was none. Concomitant medications included medications for an acid reflux. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: ER2613), via an unspecified route of administration, administered in left arm on 16Apr2021 around 13:00 (at the age of 50-year-old) at single dose for COVID-19 immunization. The patient stated he got the COVID shot and started having problems. He stated he hadn't figured out what was the cause, clarifying he had all kinds of medical tests done, but everything came back normal. He couldn't figure out why he had the cough. He didn't have a cough until he took the last COVID shot in May2021. The patient stated if this was a side effects from the vaccine. They were thinking it might be asthma, he had never had asthma. The patient had tests on his heart. Trying to figure out if that's it or what. The patient clarified his problem as cough and heaviness to the chest in May2021 which began week after the second dose on 12May2021. The patient was coughing so much his ribs get sore in May2021. He started off as a mild, little cough. Had gotten worse. The patient was also experiencing shortness of breath together with the cough in May2021. The events required visit to emergency room and physician office. The doctor ran a chest x-ray. The patient was also having stomach pain too which began around the same time as the cough. The patient thought it was just gas and an acid reflux situation. Was on medicine for acid reflux. Then it was changed to a different medication and the stomach pain stopped. A CT of abdomen and pelvis was performed. Ultrasound of thyroid was performed. All tests performed had come back normal. He then contacted his heart doctor, who started running tests on his heart. The patient then went through the ER and was admitted to the hospital for tests. Hospital did a lung function test, which showed back normal. The patient was admitted to hospital on 29Jul2021 and was kept for 4 days. The outcome of the events Cough and heaviness to the chest was not recovered, of the event stomach pain was recovered in 2021, of the other events was unknown.