chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report from a contactable consumer. A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown, expiry date: unknown) via unknown route of administration on unspecified date as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. After vaccination, the patient had experienced dizziness (on Tuesday) on unspecified date. It was better yesterday but was bad today. The outcome of event was not recovered.    Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Disease recurrence, Feeling abnormal, Headache, Nausea
Clinical narrative: Then it went away. Then she started to experience the headache again today; Headache; Nausea; Vertigo; Fever; Feel bad; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number and Expiration date not reported) via an unspecified route of administration, in arm left, on 26Jan2021 at 3:15PM (at the age of 74 years), as a single dose for covid-19 immunization. The patient medical history included she had the flu shot, but believes it was a month or two ago prior vaccination within 4 weeks and concomitant medications were not reported. She stated she take a lot of pills. She has morning and night pills. There was no history of previous immunizations with the Pfizer vaccine that considered as suspect. There was no additional vaccine administered on same date of Pfizer suspect. She had the first shot on 26Jan2021 (Tuesday), and she felt okay the day of and then on 27Jan2021 (yesterday) she started to feel bad. She had a headache, nausea, vertigo, and fever. Patient stated that she did not wake up with it or anything, she noticed it around lunch it was not real bad. Then it went away. Then she started to experience the headache again on 28Jan2021 (today) around lunch. She still currently has the headache, but it is minute/slight. She has nausea and vertigo. It was real bad last night. She had some Dramamine and took it for the nausea. The nausea and vertigo is not as bad now. She stated that she is assuming these side effects are from the shot, it is such a coincidence. She is questioning if these events are from the shot. The patient underwent lab tests which includes Body temperature of 100.1 on 27Jan2021 that evening and the last temperature reading she took was 99.8 on 28Jan2021 (Today). Outcome of the events headache, nausea, vertigo, and fever was reported as recovering and Feeling bad, Disease recurrence was reported as unknown.  Follow-up attempts have been completed and no further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vertigo
Clinical narrative: Then it went away. Then she started to experience the headache again today; Headache; Nausea; Vertigo; Fever; Feel bad; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number and Expiration date not reported) via an unspecified route of administration, in arm left, on 26Jan2021 at 3:15PM (at the age of 74 years), as a single dose for covid-19 immunization. The patient medical history included she had the flu shot, but believes it was a month or two ago prior vaccination within 4 weeks and concomitant medications were not reported. She stated she take a lot of pills. She has morning and night pills. There was no history of previous immunizations with the Pfizer vaccine that considered as suspect. There was no additional vaccine administered on same date of Pfizer suspect. She had the first shot on 26Jan2021 (Tuesday), and she felt okay the day of and then on 27Jan2021 (yesterday) she started to feel bad. She had a headache, nausea, vertigo, and fever. Patient stated that she did not wake up with it or anything, she noticed it around lunch it was not real bad. Then it went away. Then she started to experience the headache again on 28Jan2021 (today) around lunch. She still currently has the headache, but it is minute/slight. She has nausea and vertigo. It was real bad last night. She had some Dramamine and took it for the nausea. The nausea and vertigo is not as bad now. She stated that she is assuming these side effects are from the shot, it is such a coincidence. She is questioning if these events are from the shot. The patient underwent lab tests which includes Body temperature of 100.1 on 27Jan2021 that evening and the last temperature reading she took was 99.8 on 28Jan2021 (Today). Outcome of the events headache, nausea, vertigo, and fever was reported as recovering and Feeling bad, Disease recurrence was reported as unknown.  Follow-up attempts have been completed and no further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Headache, Heart rate increased, Pain in extremity, SARS-CoV-2 test
Clinical narrative: headache/Headache was reported as worsened; rapid heart rate; arm hurt; This is a spontaneous report from a contactable consumer (patient).   A 34-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: UNKNOWN, Expiration date: UNKNOWN), via an unspecified route of administration on 22Dec2020 at 10:00 (at the age of 34-years-old) as 1ST DOSE, SINGLE in the left arm for covid-19 immunization. Patient medical history included patient tested positive for COVID-19 on 09Sep2021, patient had loss of taste and smell; next day horrible diarrhea; third day she had a headache for two days; then on day four or five she got a slight fever. The whole time starting on day three her heart was racing and she couldn't sleep. States her rapid heart rate was resolved about two weeks before the vaccine. She was still recovering her sense of taste. Mentioned she saw a cardiologist and had an echocardiogram that was normal (On an unknown date in 2021). She has continued to experience the episodes of resting tachycardia but not so often now. Maybe once every two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Dec2020, the patient experienced a headache and rapid heart rate that night and was up all night and headache reported as worsened. Patient mentioned that she previously had COVID-19 infection in Sep2020. Some of how it hit her, like the resting tachycardia, it seemed like some of her COVID symptoms came back that first night. Patient arm hurt but she felt like that was related to the administration of the shot. Patient states that her COVID symptoms had all gone away and then they came back but only for that first night after the first dose. At the time of this report event pain in arm was recovered on 25Dec2021, heart rate increased was recovering and the event headache aggravated was not recovered.    Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dyslexia
Clinical narrative: can't spell or anything; This is a spontaneous report from a contactable consumer (Patient).  A 78-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number; Unknown, NDC number: unknown, Expiration date: unknown), via an unspecified route of administration on 26Jan2021, Tuesday as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  Caller reported that he had the first Pfizer BioNTech Covid-19 vaccine on Tuesday, 26Jan by invitation from the (Place). He was to get the second one in 3-4 weeks. He was eligible to get it or selected to have it probably due to his age. On an unspecified date in 2021, the patient can't spell or anything and there are lots of things he can't do, but he was still blessed.  He went up there to the desk and they gave a fact sheet for recipients and care givers that talks about the authorization of the Pfizer BioNTech Covid-19 vaccine, it was 5 pages both sided, so 10 pages. While waiting, he counted the name Pfizer BioNTech had been written 54 times on these pages and in one section where there was questions, in 1 paragraph they have it written 7 times. He was assuming it's an advertisement, that it's put out for advertisement, saying here it's promotional. They make these statements in here that it's not approved and approved, but it is not FDA approved to prevent Covid virus. It says that a number of times in there. Soon they gave him 3 other sheets about the Vsafe health check and to scan information to get emails and no where on this information does it say the place. He read this sheet handed to him and this was the only information available and there was no FDA approval to prevent Covid, but they only mention the one from Pfizer. They send these emails when there are about 5-8 different ones out there and they the way this information was published it's only Pfizer when there were 2-3 times nothing had been approved it seems to him. Patient wants to know which one was better or was there a better one that did not have to have a second shot, or if the second shot needed. He had to take another shot in 3 weeks. Says he was going to take it with a grain of salt. Patient was enquiring that was there another vaccine equal to this one, why was Pfizer the only one published. Since none of the information says place was Pfizer giving the vaccine to them free or paying them. Also, recommended caller to contact facility where received vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Pain in extremity
Clinical narrative: He also stated his arm was sore after both injections; Arm soreness worse after second injection making it hard to sleep; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer reported for himself. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that a caller on the line who just disconnected that stated he completed both of the COVID vaccines. He wanted to know if there was an blood test to check for antibody for immunity. He also stated his arm was sore after both injections. It was worse after the second injection, making it more difficult for him to sleep. She provided him with Medical Information's number. Caller disconnected prior to transfer. Reporter confirmed he was on the line today, 28Jan2021. He said his wife had it at the same time and did not have any problems. The outcome of the event arm was sore after both injections was not recovered and unknown for other event.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Insomnia, Pain in extremity
Clinical narrative: Arm soreness worse after second injection making it hard to sleep; Arm soreness worse after second injection making it hard to sleep; Arm soreness worse after second injection making it hard to sleep; This is a spontaneous report from a Pfizer-sponsored program, via consumer (Patient). A male patient of an unspecified age received second dose of bnt162b2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization.The patient medical history and concomitant medications were not reported. The patient received first dose included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. On an unknown date, after both injections, the patient experienced arm soreness which was worse after second injection making it hard to sleep. The patient enquired if there was any blood test to check for antibody for immunity. The patient also stated that his wife had vaccine at the same time and did not have any problems. The outcome of the event arm soreness was reported as not recovered and making it hard to sleep as unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): 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: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Dyspnoea, Injection site pain, Pyrexia
Clinical narrative: Fever; breathing poorly; chills; anxiety; vomiting every 30 min for hours and can't hold any food or liquid down; soreness of her arm at the injection site; throat was closing; This is a spontaneous report from a contactable consumer (parent). A 24-year-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Lot Number: EL9262), via an unspecified route of administration, on an unspecified date at 08:30 (at the age of 24-year-old) as 2nd dose, single, in left arm for COVID-19 immunization. The patient's medical history included allergic to penicillin when she was little. Concomitant medications were not reported. the patient previously received first dose of BNT162B2 (Lot Number: EL3246), via an unspecified route of administration, on 05Jan2021, as single dose in the left upper arm for COVID-19 immunization, and experienced breathing issues ever since the first vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. There was no illness at time of vaccination. On an unspecified date after second dose, the patient experienced fever, breathing poorly, vomiting every 30 min for hours and can't hold any food or liquid down, so she was just vomiting bile. Patient had chills and fever. Patient could not eat or hold anything down. Breathing was really laboured. Right after receiving vaccine, patient felt like her throat was closing and doctor watched her for an hour. On an unspecified date, at 01:00 in the morning, patient felt like she can't breathe and felt like anxiety. Patient experienced soreness of her arm at the injection site, but this was to be expected. patient followed basic treatment methods, by staying hydrated, applying Vapor rub on chest and under nose, which helped her, and did not use Acetaminophen and hydration drink which she had. The clinical outcome of the events soreness of her arm at the injection site and throat was closing was unknown. The clinical outcome of all other events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Vomiting
Clinical narrative: Fever; breathing poorly; chills; anxiety; vomiting every 30 min for hours and can't hold any food or liquid down; soreness of her arm at the injection site; throat was closing; This is a spontaneous report from a contactable consumer (parent). A 24-year-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Lot Number: EL9262), via an unspecified route of administration, on an unspecified date at 08:30 (at the age of 24-year-old) as 2nd dose, single, in left arm for COVID-19 immunization. The patient's medical history included allergic to penicillin when she was little. Concomitant medications were not reported. the patient previously received first dose of BNT162B2 (Lot Number: EL3246), via an unspecified route of administration, on 05Jan2021, as single dose in the left upper arm for COVID-19 immunization, and experienced breathing issues ever since the first vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. There was no illness at time of vaccination. On an unspecified date after second dose, the patient experienced fever, breathing poorly, vomiting every 30 min for hours and can't hold any food or liquid down, so she was just vomiting bile. Patient had chills and fever. Patient could not eat or hold anything down. Breathing was really laboured. Right after receiving vaccine, patient felt like her throat was closing and doctor watched her for an hour. On an unspecified date, at 01:00 in the morning, patient felt like she can't breathe and felt like anxiety. Patient experienced soreness of her arm at the injection site, but this was to be expected. patient followed basic treatment methods, by staying hydrated, applying Vapor rub on chest and under nose, which helped her, and did not use Acetaminophen and hydration drink which she had. The clinical outcome of the events soreness of her arm at the injection site and throat was closing was unknown. The clinical outcome of all other events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; aching body; congestion; headaches; This is a spontaneous report from a contactable nurse (patient herself). A 63-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number EL3302), via an unspecified route of administration, administered in Arm Right on 13Jan2021 at 19:00 as a single dose for covid-19 immunization at nursing home/senior living facility. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 25Jan2021, the patient experienced pyrexia, aching body, congestion, and headaches. On 27Jan2021, the patient had nasal swab test for covid-19 and results are pending at the time of report. The patient also reported that she had to visit the doctor due to the events. No treatment was received for the events. The outcome of the events was reported as not recovered.   No follow-up attempts are possible. No Information for the lot/ batch cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; soreness in her left arm; This is spontaneous report from a contactable consumer (patient) reported for herself. The 75-year-old female patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown, Expiry date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location, on an unspecified date (age at vaccination was 75 years) as UNKNOWN, SINGLE dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The caller stated that she got the vaccine shot yesterday and she felt good all day. She stated that she woke up at 10:30 and had a bad headache and soreness in her arm on an unspecified date. Stated that the soreness was going away. Wanted to know the best pain medication to take for a headache. Clarified that she had the Pfizer Covid 19 vaccine. Clarified that it was the left arm that was sore. The outcome of the events was unknown.  Information on Lot/Batch has been requested.  Follow-up (16Apr2021): 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: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Extrasystoles
Clinical narrative: After taking the first dose of the vaccine, within 3 hours he could feel the skipped heart beat; This is a spontaneous report from a contactable Consumer (patient, self-reported). A 86-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 13Jan2021, as a single dose for COVID-19 immunization. The patient's medical history included skipped heart beat for which took medication Pacerone 4 years ago. Concomitant medications were not reported. The patient reported that he got the COVID-19 virus shot on the 13Jan2021, and about 14 days ago he started having skipped heart beats. He said he had a condition, and took a medication for skipped heart beat that he started taking 4 years ago that when they gave it to him it cured the problem of the skipped heart beat for 4 years. He said after he took the first dose of the vaccine, within 3 hours he could felt the skipped heart beat on 13Jan2021, and he didn't know if it had to do with it or not, but he was calling to see if anyone else had reported this since the only thing on the paperwork he was given that references the heart was a fast heart beat. The patient reported that the skipped heart beat happened from time to time, every 3-4 hours it might happen, though sometimes it didn't happen. He said last night it did not happen any and that it was not serious, it was more of an irritating thing. He took medication, Pacerone, cured him in three days, and he only skipped one day of taking it in those 4 years. He already called his doctor and was gonna see him soon, but he wanted to get the second vaccine because he was an attorney and he was in meetings face to face with people, so he wanted to take the second dose which was scheduled on 02Feb2021, The patient said something about 14 days, and he was thinking he would go and take the second dose anyway and see what happens, then thought that might be stupid, but he wanted to take it so bad, but if it caused these heart beats not a good idea possibly. There was product complaint. The patient was unwilling to complete the report. and declined to complete a report. No further details captured, reported, or documented at this time. Outcome of the event was unknown.  Information on the lot/batch number has been requested. 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: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: has had a temperature of 102.5; body aches; shivering; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male consumer received unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation/Lot number: Unknown, Expiry Date: Unknown), via unknown route of administration on left shoulder area  (Deltoid Left) on an 27Jan2021 at 15:30 as a SINGLE DOSE for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any vaccine within 4 weeks prior to the first administration date of the suspect vaccine. The patient was not administered with additional vaccines on same date of the Pfizer Suspect. The patient did not experience any adverse event following prior vaccination. The patient did not have any history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). On 27Jan2021, the patient experienced shivering, body aches and temperature of 102.5. He stated that yesterday he got the vaccine and had a temperature of 102.5, body aches, and shivering. The patient received Tylenol his temperature goes down to 100.0 but not lower. This started late last night. The patient was taking the Tylenol every 5 hours and a pain pill Ultracet but the temperature did not decrease below 100. Outcome of the events were not recovered.  Information on lot/batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood
Clinical narrative: Feeling sad; This is a spontaneous report from a contactable nurse (Patient). An unspecified age of female patient received first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: not reported, Expiry Date: not reported) via an unspecified route of administration, administered on unknown date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unknown date the patient experienced, consumer calling states she has taken the first dose of the Pfizer COVID 19 vaccine three weeks ago and will get the second dose tomorrow. She has not called into to report before but after the first dose she has had a sad feeling. She is asking has this been commonly reported, when ask if she would be willing to complete the report today she states in the fact sheet it said to report to CDC first and she does not want to report to Pfizer and declined to report. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 72-years-old male patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL3247; Expiration Date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jan2021 at 17:45 (age at the time of vaccination was 72 years), as single for COVID-19 immunization. The patient's medical history included fungal infection on his body. He said he does not know the name of the fungus, but he was diagnosed with the fungal condition about 7-10 years ago. On Oct 2020, (about 3 weeks ago at the time of report), the patient had shingles vaccine about 3 weeks ago. He said he was scheduled to receive a second Shingles Vaccine dose in Jan2021. He said he cancelled his appointment for his second Shingles Vaccine dose in Jan2021 because he wanted to take the COVID-19 Vaccine instead. "The patient height: 5'9-1/2" as provided as, who said he used to be 5'10" and was sure his height had gone down". The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date in Jan 2021, (after 2 to 3 days of getting his first COVID-19 vaccine), the patient saw something on his feet that looked like a rash and spread to the lower part of his body, especially in his groin area. The patient said, he wears boots, so he did not notice anything sooner than that. The patient did not visit emergency room and physician Office. The patient reported, he had his Shingles Vaccine about 3 weeks ago. The patient did not visit emergency Room and physician Office. No lab tests and procedures were reported. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Caller said that after she took the second shot  on 20Jan2021, she noticed the rash came back on 20Jan2021; This is a spontaneous report from a contactable consumer (Patient). A 63-years-old female patient of weight 83.91 kilograms and height 160 centimetres received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL1283 and expiry date: Apr2021) via intramuscular route of administration at arm left on 20Jan2021 as single dose for COVID-19 immunisation. The patient medical history was not reported, and concomitant therapy was reported as no. The patient previously received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EH9899), via intramuscular route of administration at arm left on 30Dec2021 for Covid-19 and experienced rash, sore arm for a day and a slight headache. On 20Jan2021, the patient experienced rash came back which required treatment with over the counter product (Cetraphil cleanser (Lot: 316776), Dove peak moisture bath wash (Lot: 08280JU41), Witch hazel astringent (Lot: 53849), Benadryl cream (lot: 2910LV/1, Expiration: Sep2022) and tablets (Lot: SMF075, Expiration: Jul2022), Triderma eczema fast healing face and body cream (Lot: 05440289, Expiration: Oct2023) and calamine lotion (Lot: 541128, Expiration: Nov2017)) which was later spread to a much larger area. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; sick two weeks after getting the first dose; soreness; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via unspecified route of administration on an unknown date about two weeks ago from the date of report, in Jan2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. After receiving the vaccine, patient had some soreness. On 27Jan2021 (a day prior to the report), patient had a fever and was sick two weeks after getting the first dose. The patient thought he had COVID and underwent COVID-19 test and it was revealed that the patient was negative. The patient wanted to know if side effects appear that long after getting the vaccine and the time frame to get the second dose was 3 weeks or shorter. Outcome of the events was reported as unknown.  No follow-up attempts were possible. Information on Lot/batch number cannot be obtained. No further information was expected
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Exposure to SARS-CoV-2
Clinical narrative: This is a spontaneous report from a contactable Consumer (patient). A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch number: EN5318) via an unspecified route of administration on 07Feb2021 as first, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient just taking homeopathic medication, antiviral and I just have an auto immune (sentence incomplete). She stated, I received my first dose Sunday, and then last night I got a call from my daughter to let me know that my granddaughter may have been exposed to COVID-19 either Thursday or Friday of last week and the person who she was exposed to in her school class tested positive for COVID-19 yesterday. So, I am just a little bit concerned because of course after Sunday that I got my first shot, I had no idea that I had a possible exposure. So, it is just, I am trying to find out, what are the effects would be if my granddaughter, she is tested today and what may happen to me because I had the first dose and then I may be exposed to COVID-19. She is scheduled for second dose on 28Feb2021. The event assessed as non-serious. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain in extremity
Clinical narrative: Headache; aching joints; sore arm; This is a spontaneous report from a contactable 62-year-old female consumer reported for herself.  A 62-year-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 04Feb2021 (patient was 62-year-old at the time of vaccination) at single dose for covid-19 immunization. The patient's medical history was not reported. The patient's medical history was not reported. The patient did not have any allergies to medications, food, or other products. Concomitant medication included desvenlafaxine succinate (PRISTIQ). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot: EL3247) via an unspecified route of administration in left arm (at the age of 62 years) on 14Jan2021 at single for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. On 05Feb2021, the patient experienced headache, aching joints, sore arm. The patient not received any treatment for the events. The patient was not hospitalized. The events were non-serious. The outcome of events was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Rash, Sensitive skin
Clinical narrative: rash on his right arm (opposite the injection site); but they are sensitive and haven't went away; it is just a smooth redness; his right forearm broke out in smooth, red spots; This is a spontaneous report received from a contactable consumer (Patient). A 86-year-old male patient received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot number: ENL318 Expiration date: unknown), via an unspecified route of administration, in Arm Left on 05Feb2021 as 1st dose, single for covid-19 immunisation (for prophylaxis). The patient medical history included ongoing asthma diagnosed when he was 39 years old and ongoing atrial fibrillation diagnosed about 16 years ago. Patient had taken 7 drugs, and he had been taking them for years and never seen any side effects from them. patient had not received any other vaccines on the same day as the COVID vaccine. On 07Feb2021, patient experienced he had broken out on the inside of his right forearm, with a rash, He has a rash on his right arm (opposite the injection site),, but it is not bumpy, it was just a smooth redness that measure about 3-4 inches in diameter, just below his elbow on the inside of his right forearm that does not have any extra heat, but it was sensitive to the touch and haven't went away. it was reported that, Rash had mostly stayed the same, but if anything, it was slightly improved. Patient was due for his second dose on 26Feb2021. He had not talked to his doctor but used some cortisone on it to treat. The outcome of events his right forearm broke out in smooth red spots, rash on his right arm (opposite the injection site) was recovering while other events were not recovered.  Follow-up (09Feb2021): This is a follow-up spontaneous report from a contactable consumer., new information included suspect product, events detail, batch no. medical history.   Follow-up attempts are completed. No further information is expected
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Moderately sore arm; This is a spontaneous report from a non-contactable consumer. A 54-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201), via an unspecified route of administration in right arm on 09Feb2021 as single dose for COVID-19 immunisation. The medical history of the patient included blood Pressure, thyroid. The patient's concomitant medications include unspecified medications for blood pressure, thyroid. No Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 2021 the patient experienced moderately sore arm on an unspecified date. The event was considered as non-serious. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Erythema
Clinical narrative: Redness on right side of neck and of right side of back; Blood pressure was measured at 140/70 and in 30 min it went down to 120/70; This is a spontaneous report from a contactable consumer (patient). A 30-years-old male patient received BNT162B2 (COMIRNATY, Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified), dose 1 via an unspecified route of administration, administered in Arm Right on 08Feb2021 at 15:15 as 1st dose, SINGLE for covid-19 immunisation at workplace clinic (30 year at time of vaccination). The patient medical history and concomitant medications were not reported. On 08Feb2021, the patient had his blood pressure checked which shows 140/70 and in the next 30 min it went down to 120/70. The patient also experienced redness on right side of neck and of right side of back. The patient reports about receiving shot of intervenors Benadryl as a therapeutic measure. The outcome of the events was reported as recovered at the time of report on 08Feb2021 (as reported).  No follow-up attempts are needed. No information about batch/lot number cannot be obtained.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Redness on right side of neck and of right side of back; Blood pressure was measured at 140/70 and in 30 min it went down to 120/70; This is a spontaneous report from a contactable consumer (patient). A 30-years-old male patient received BNT162B2 (COMIRNATY, Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified), dose 1 via an unspecified route of administration, administered in Arm Right on 08Feb2021 at 15:15 as 1st dose, SINGLE for covid-19 immunisation at workplace clinic (30 year at time of vaccination). The patient medical history and concomitant medications were not reported. On 08Feb2021, the patient had his blood pressure checked which shows 140/70 and in the next 30 min it went down to 120/70. The patient also experienced redness on right side of neck and of right side of back. The patient reports about receiving shot of intervenors Benadryl as a therapeutic measure. The outcome of the events was reported as recovered at the time of report on 08Feb2021 (as reported).  No follow-up attempts are needed. No information about batch/lot number cannot be obtained.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Fatigue; localized soreness; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 09Feb2021 at 11:00 as 2nd dose, single for COVID-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3247), via an unspecified route of administration in right arm on 19Jan2021 at 11:15 AM as 1st dose, single for COVID-19 immunization. Patient age at vaccination was 29 Years. Medical history included seizure disorder (since age 2). Patient had no allergies to medications, food, or other products. Concomitant medications included valproate semisodium (DEPAKOTE), cetirizine hydrochloride (ZYRTEC), clarithromycin (CLARITIN), ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, lycopene, magnesium oxide, manganese sulfate, nicotinamide, phytomenadione, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium molybdate, sodium selenate, thiamine mononitrate, tocopheryl acetate, xantofyl, zinc oxide (CENTRUM FORTE), dextromethorphan hydrobromide, guaifenesin (MUCINEX DM). Facility where the most recent COVID-19 vaccine was administered was workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Feb2021 at 08:00 PM, patient experienced fatigue and localized soreness. No treatment was received for the adverse events. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Malaise, Pain
Clinical narrative: Flu like symptoms; body aches; chills; feeling unwell; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 65-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection,Batch/Lot Number: EL9265), dose 1 via an unspecified route of administration, administered in Arm Right on 08Feb2021 11:15 (age at the time of vaccination was 65-year-old) as single dose for covid-19 immunisation. The patient did not have allergies to medications, food, or other products and other medical history none. Concomitant medication(s) (within 2 weeks of vaccination) included doxazosin (DOXAZOSIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Feb2021 08:00,  the patient experienced Flu like symptoms, body aches, chills, feeling unwell. No treatment received for the adverse events. The reporter considered the events was non serious. The outcome of events was unknown.  Follow-up (12May2021): Follow-up attempts completed. No further information expected .
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Lymph node pain, Pain
Clinical narrative: Uncontrollable body shakes without a fever; Pain in lymph node under left armpit; full body aches; Headache; This is a spontaneous report from a contactable consumer or other non hcp reported for himself. A 26-year-old male patient received second dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL3247; Expiration date was unknown), via an unspecified route of administration, administered in Arm Left on 10Feb2021 10:15 (at the age of vaccination 26-year-old) as 2nd dose single, for COVID-19 immunization. Medical history included asthma, Heart arrhythmia. Patient previously received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL3247; Expiration date was unknown), via an unspecified route of administration, administered in left arm on 19Jan2021 13:30 (at the age of vaccination 26-year-old) as 1st dose, single for COVID-19 immunization. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had no known allergies. On 11Feb2021 01:00 the patient experienced uncontrollable body shakes without a fever, pain in lymph node under left armpit, full body aches, headache. Patient did not receive any treatment for events. Reporter considered all the events as non-serious. The outcome of event was Not Recovered/Not Resolved.  Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Vaccination site pain
Clinical narrative: Strong headache after shot, constant headache during the day of the shot; Pain on the arm where the shot was given; Tiredness; Weakness; This is a spontaneous report from a contactable consumer(patient). A 26-years-old female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9262), dose 1 via an unspecified route of administration, in left arm on 11Feb2021 17:15 (at 26-years age) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Facility where COVID-19 vaccine was administered was at a Public Health Clinic/Veterans Administration facility. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced strong headache after shot, constant headache during the day of the shot, pain on the arm where the shot was given, tiredness and weakness on 11Feb2021 at 05:15 PM. No treatment received for reported adverse event. Patient not tested for COVID-19 since the vaccination. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: This is a spontaneous report received from a contactable other health professional (patient). A 32-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318) via an unspecified route of administration in the left arm on 29Jan2021 at 08:45 (at the age of 32-year-old) as a single dose for COVID-19 immunization in hospital. The patient had no medical history and was not allergic to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ascorbic acid (VIT C), Vitamin d nos, Zinc, D-mannose and neuro effect within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Jan2021 after about 1 hour of vaccination, the patient experienced itching for about 24 hours and then developed a rash on 04Feb2021 (1 week after vaccination) starting on arms and side stomach. Since then, it had spread to upper back, neck, face and legs. The rash was not itchy. Patient did not receive any treatment for the events. The outcome of the event itching was recovered on an unspecified date in Jan2021, and event developed a rash 1 week after vaccination starting on arms and side stomach. Since then, it has spread to upper back, neck, face and legs was not recovered. Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: body aches; headache; low fever; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 42-year-old male patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247, Expiration date: unknown), via an unspecified route of administration, administered in right arm on 11Feb2021 at 16:45 pm (age at vaccination was 42 years) as UNKNOWN, SINGLE dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have allergies to medications, food, or other products. On 12Feb2021, the patient experienced body aches, headache and low fever. The facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The reporter assessed the events as non-serious. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.