chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: He wanted to know if there would be an effect to the efficacy of the vaccine if he would take Miralax; has a stomach issue; This is a spontaneous report from a contactable consumer. This male consumer reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on 17Mar2021 as a single dose for covid-19 immunization; macrogol 3350 (MIRALAX), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown dose, daily for an unspecified indication. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was asking if he can take Miralax or not. He mentioned that the vaccine and Miralax contain polyethylene glycol. He is taking Miralax almost everyday and he does not remember if he has taken a dose of Miralax after his first dose. He wanted to know if there would be an effect to the efficacy of the vaccine if he would take Miralax. He got his second dose today. He has a stomach issue on an unspecified date. Outcome of the event was unknown. Description of Product Complaint: He called earlier and someone called him back. He missed the call because he was on the other line for a business call. He got his COVID shot. He takes MiraLax everyday and that is polyethylene glycol. He has a stomach issue. Because there is polyethylene glycol in the vaccine is it ok to still take his regular MiraLax. Reference number: he doesn't have one. He was not asked for lot number when he called previous. He didn't do a report. He would not have any information such as lot numbers for MiraLax or COVID shot to provide. His question is because basically there is MiraLax in the vaccine and he takes MiraLax. He doesn't want to screw up the efficacy of the vaccine if he is taking more. Caller declined to proceed with a report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Felt like she took a lot of Benadryl; made her sleepy; This is a spontaneous report from a contactable consumer or other non-health care professional (mother). This is report 3 of 4. A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient experienced felt like she took a lot of benadryl; made her sleepy. Outcome of the event was unknown.   No follow-up attempts are possible. Information on Batch number, Lot number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: With the first dose, only the sore arm was experienced.; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3247 and expiry date were not reported), via an unspecified route of administration, in the left arm on 23Feb2021 at 02:15 PM (age at the time of vaccination was 37-year-old), as dose 1, single for COVID-19 immunisation. The patient's medical history included HLAB27 associated anterior uveitis, exercise induced asthma, psoriasis and food allergy (kiwi), from an unknown date and unknown if ongoing Kiwi. Concomitant medications included norethindrone (NORETHISTERONE), fish oil, vitamin D3 and multivitamins taken for an unspecified indication, start and stop date were not reported. The patient was allergic to kiwi. The patient was not diagnosed with COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. The patient did not receive any vaccine prior to COVID-19 within four weeks. On 23Feb2021, the patient experienced sore arm. On 16Mar2021, the patient received second dose of BNT162B2. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath, happened after both 1 st shot and 2 nd shot.; This is a spontaneous report received from a non-contactable consumer, the patient. A 57-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: UNKNOWN) in the right arm via an unspecified route on 26Feb2021 at 10:00 as DOSE 1, SINGLE (at the age of 57-years-old) for COVID-19 immunisation. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Medical history included , covid-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). Since the vaccination, patient had not been tested for COVID-19. The patient was allergic to lisinopril and losartan. Patient later received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: UNKNOWN) in the right arm via an unspecified route on 19Mar2021 at 10:30 as DOSE 2, SINGL (at the age of 57-years-old) for COVID-19 immunisation. On 26Feb2021 at 20:00, the patient was having difficulty in breathing. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Abuterol inhaler was given as treatment the for the event. The clinical outcome of the event difficulty in breathing was resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Updated narrative to reflect the Dose Description as DOSE 2, SINGLE, Lead sentence (a non-contactable consumer), medical history (COVID-19) and vaccination facility information was added.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Wrong product administered
Clinical narrative: she received the first dose of her Pfizer-Biontech Covid19 vaccine 25Feb2021.  Then, 8 days later on 05Mar2021 she received a dose of the Moderna Covid19 vaccine; got really sick; This is a spontaneous report from a contactable consumer (patient). A female 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) via an unspecified route of administration on 25Feb2021 as dose 1, single and second dose of Moderna Covid19 covid-19 vaccine m-RNA (MODERNA COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 05Mar2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that she "got really sick" on an unspecified date in 2021. She wants to know if she's covered or if she should get the second dose of her Pfizer series? The response to the patient's question was that the different covid vaccine products on the market have not been compared to each other nor has switching between products been evaluated. Provided CDC recommendations from the interval do that state that if a dose was given at a shorter interval than the 4 days early, that dose should not be repeated. The outcome of the event sickness at the time of reporting was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: Arm was sore; She had problem with her ears; She had like echoing in her ears; She heard like a banging sound in her ears; This is a spontaneous report received from a contactable consumer. A 84-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: EN6205) via intramuscular route of administration at left deltoid on 12Mar2021 around 13:30 (at the age of 84-year-old) as dose 2, single for COVID-19 immunisation. Medical history included asthma, underactive thyroid, open heart surgery and aortic valve replacement on 14Feb2020 and she also had 24Feb2020 a pacemaker, acid reflux. Concomitant medications included warfarin, pantoprazole sodium sesquihydrate (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) taken 40mg, tablet, once a day for Acid reflux/ reporter states "it's pantoprazole", fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken 50 mcg/reporter states "that's liquid spray in her nostril, two sprays every night" for asthma, warfarin (WARFARIN)/Reporter stated, she was taking blood thinners or Warfarin. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9266) via intramuscular route of administration at right deltoid on 19Feb2021 (at the age of 84-year-old) as dose 1, single for COVID-19 immunisation. Reporter stated that she was wondering if you heard of any of the side effect from the Pfizer COVID 19 Vaccine. She was trying to look up online and her mother was 84, she had her second Pfizer Vaccination last Friday, she was 84 years old. So she got her second vaccination probably around 13:30 in the afternoon, she has mild, her arm was sore that was one thing, but around 10:30-11 o'clock at night, she had problem with her ears, so she had like echoing in her ears, she does not wear hear aid anything, but there was like echoing and she heard like a banging sound in her ears on Mar 2021, so she had that for a couple hours but then she laid down she went her bed and next morning she was fine. She reported it to her primary care physician so last night which was yesterday, one day before a week of the second vaccine she had, last night around 6:15 in the evening she had another bout of echoing in her ears. Could this be something from the Pfizer Vaccine, have you heard reports for that? Outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Incorrect route of product administration
Clinical narrative: route subcutaneous; Dizziness; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 62-years-old female patient received BNT162B2 (Pfizer-BioNTech Covid 19 Vaccine, formulation: Solution for injection, batch/lot number and expiry date not reported), via subcutaneous route of administration on 26Feb2021 (at the age of 62-years old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation and ttreprostinil sodium (REMODULIN, formulation: Injection, batch/lot number: 2101788, Expiry date: 30Nov2021), via subcutaneous route of administration from 04Feb2005 to an unspecified date, at 2.5 mg/ml, subcutaneous from an unspecified date and ongoing, the current dose is 0.0115 ug/kg, continuous for pulmonary arterial hypertension. Medical history included ongoing pulmonary arterial hypertension. Concomitant medication(s) included sildenafil citrate (REVATIO) taken for an unspecified indication, start and stop date were not reported. The patient experienced dizziness in 2021. The patient received vaccine in an inappropriate route of administration (subcutaneous). The outcome of the event is unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain
Clinical narrative: Body aches; This is a spontaneous report from a contactable consumer, the patient. A 56-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL9261, expiration date: not reported) via an unspecified route of administration on 16Feb2021 (at the age of 56-years-old) as dose 2, single for COVID-19 immunization and ademetionine (SAM-E), unspecified route of administration, started in 2021 two weeks after her second dose, lot number and dose were not reported for supplementation therapy. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not test for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EL3302), via unspecified route of administration on 26Jan2021 (at the age of 56-years-old), as a single dose for COVID-19 immunization. On an unspecified date after second dose in 2021 the patient experienced body aches. The patient had reported that it was not a serious adverse event, but in the interest of helping to collect data on impact of the vaccine the patient wanted to share it. About two weeks after her second dose she started a supplement, SAMe. She found that she immediately had significant body aches, not dissimilar from having the flu. The patient assumed that something had taken place at the cellular level related to the interaction of SAMe and the vaccine. The clinical outcome of the event body aches was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Throat irritation
Clinical narrative: Light-headed; funny feeling in my throat; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported, Expiry Date: Unknown), dose 1 via an unspecified route of administration on 03Mar2021 (at the age of 64 years old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. On 03Mar2021 the patient experienced light-headed, funny feeling in my throat. Reporter stated that When I had my first shot, they did report it. I had a reaction there. I had a funny feeling in my throat, and I was lightheaded and that lasted for an hour. So, my doctor told me I could take a Benadryl before I went for my second shot, and I am going on Wednesday. So, I just wanted to confirm if that was ok to go. Second dose scheduled date This coming up Wednesday, this 24th (Confirmed as 24Mar2021). Reporter confirmed it as the first dose of vaccine. Events occurred after taking the shot it was about 5 minutes. The clinical outcome of the events was reported was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Vaccination site swelling
Clinical narrative: Puffy below injection; Redness; Rash; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on on 22Mar2021 at 00:00 as a single dose(at the age of 78 years)  for COVID-19 immunisation. Medical history included diabetes, high blood pressure and hyperthyroid. It was reported that the patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 at 00:00, the patient experienced redness, rash and puffy below injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of redness, rash and puffy below injection were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: amended Lot as unknown, anatomical site was deleted, closure statement updated and narrative data amended.
Sex: F
Vaccine: UNK
Symptoms: Injection site pain
Clinical narrative: took Tylenol n between doses; injection site pain; This is a spontaneous report from a contactable consumer or other non-health care professional reporting for her sister (Patient).  A 59-years-old female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no/ Lot number: not reported) via unspecified route of administration on an unknown date in Feb2021 as dose 2, single for covid-19 immunization, and Paracetamol (TYLENOL), start and stop date were not reported for an unspecified indication. Medical history and concomitant medications were not reported. Historical vaccine included patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no/ Lot number: not reported) via unspecified route of administration on an unknown date as dose 1, single for covid-19 immunization. It was reported that patient got second dose of vaccine 5 weeks ago. Reporter stated that patient was not aware of CDC recommendation of not taking Tylenol and patient took Tylenol in between doses of dose 1 and dose 2. On an unknown date patient experienced with very little reaction after second dose and reports injection site pain. Reporter wanted to know if patient should get a third vaccine since she took Tylenol or should she consult with her HCP and asking should get an antibody test. Action taken with drug paracetamol was unknown. Outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be requested.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Nervousness, Pain, Pain in extremity, Pain in jaw
Clinical narrative: developing severe jaw pain; nervous; It is still very sore top to legs, in groin area; Lymph nodes and top to legs are still throbbing; Could not even open jaw; Lymph nodes and top to legs are still throbbing; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 66-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6202) via an unspecified route of administration, administered in left arm on an unspecified date as dose 1, single for covid-19 immunization, paracetamol (TYLENOL EXTRA STRENGTH, Batch/Lot number was not reported) via an unspecified route of administration from an unspecified date to an unspecified date, at 1000 mg for jaw pain. Medical history included Follicular Cancer, Spinal issues, back pain, non-Hodgkin's Lymphoma, Treatment was started in May2018 and it was finished in August2019. Concomitant medications included zolpidem tartrate (AMBIEN) Tablet, 10 mg in evening, orally taken for pain, rituximab taken for Follicular Cancer an unspecified indication, bendamustine taken for Follicular Cancer. On an unspecified date, the patient experienced developing severe jaw pain, nervous, it is still very sore top to legs, in groin area, lymph nodes and top to legs are still throbbing, could not even open jaw. The patient developed severe jaw pain, about 2 days afterward. She stated that the situation was very scary for her, she didn't know what was going on. She said that the pain "goes away and sometimes comes back". When probed for the outcome of the event she stated, it was still sore but it's better. But it is still very sore. In her top to her legs, in groin area. She was nervous about receiving her second dose as scheduled, tomorrow, Tuesday, she due to get her second shot and she was not quite sure if she should get that shot. And so she was wondering if anybody had that kind of reaction to the first shot. She was nervous, it was still very sore top to legs, in groin area, lymph nodes and top to legs were still throbbing. No lab work done. The patient reported date of vaccination as "I think it was on 9Mar2021". Treatment received with amoxicillin and Tylenol 1000 mg for jaw pain but it did not help, and treatment received with Tylenol for pain in extremity (reported as very sore top to legs, in groin area), pain (reported as Lymph nodes and top to legs were still throbbing). Outcome of the events were unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Trismus
Clinical narrative: developing severe jaw pain; nervous; It is still very sore top to legs, in groin area; Lymph nodes and top to legs are still throbbing; Could not even open jaw; Lymph nodes and top to legs are still throbbing; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 66-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6202) via an unspecified route of administration, administered in left arm on an unspecified date as dose 1, single for covid-19 immunization, paracetamol (TYLENOL EXTRA STRENGTH, Batch/Lot number was not reported) via an unspecified route of administration from an unspecified date to an unspecified date, at 1000 mg for jaw pain. Medical history included Follicular Cancer, Spinal issues, back pain, non-Hodgkin's Lymphoma, Treatment was started in May2018 and it was finished in August2019. Concomitant medications included zolpidem tartrate (AMBIEN) Tablet, 10 mg in evening, orally taken for pain, rituximab taken for Follicular Cancer an unspecified indication, bendamustine taken for Follicular Cancer. On an unspecified date, the patient experienced developing severe jaw pain, nervous, it is still very sore top to legs, in groin area, lymph nodes and top to legs are still throbbing, could not even open jaw. The patient developed severe jaw pain, about 2 days afterward. She stated that the situation was very scary for her, she didn't know what was going on. She said that the pain "goes away and sometimes comes back". When probed for the outcome of the event she stated, it was still sore but it's better. But it is still very sore. In her top to her legs, in groin area. She was nervous about receiving her second dose as scheduled, tomorrow, Tuesday, she due to get her second shot and she was not quite sure if she should get that shot. And so she was wondering if anybody had that kind of reaction to the first shot. She was nervous, it was still very sore top to legs, in groin area, lymph nodes and top to legs were still throbbing. No lab work done. The patient reported date of vaccination as "I think it was on 9Mar2021". Treatment received with amoxicillin and Tylenol 1000 mg for jaw pain but it did not help, and treatment received with Tylenol for pain in extremity (reported as very sore top to legs, in groin area), pain (reported as Lymph nodes and top to legs were still throbbing). Outcome of the events were unknown.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Glycosylated haemoglobin
Clinical narrative: The glucose level went up after the second shot 20-25 points; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 25Mar2021 (at the age of 75-years) as dose 2, single for covid-19 immunisation and patient took Metformin 1000 mg, tablet, by mouth twice a day for diabetes. The patient medical history included diabetes from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 04Mar2021 at 12.45 (at the age of 75-years) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced glucose level went up after the second shot 20-25 points. He has diabetes and takes his blood every day. His glucose level had been under control and under 105 every day. Starting on 07Mar2021 and on, it's been spiking about 25 points higher than normal. The glucose level went up after the second shot 20-25 points. He said it was unusual for it to go up. His previous Internist that retired told him that he would have times during the year like holidays that he would see his levels go up. He was advised to increase his Metformin 1000 mg dose and add 1/2 tablet daily to help correct the increase. He normally takes 1000mg twice daily for a total of 2000mg. With the increase the total dose is 2500mg daily. Patient was treating this now by exercising and stuff like that to keep it good. Caller confirmed that he is adding 1/2 tablet of Metformin daily since 07Mar2021. Caller confirmed total daily dose as 2500 mg per day. The patient underwent lab tests and procedures which included Spiking of blood sugar shows 25 point or higher, A1C for diabetes was 6.5 on 07Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Chest pain, Discomfort, Dizziness
Clinical narrative: getting sick; get discomfort; Soreness wrapped around under my armpit, right arm, chest area, not debilitating/Pain traveled under armpit and around the right side of the chest/Sore back and armpit; Soreness wrapped around under my armpit, right arm, chest area, not debilitating/Pain traveled under armpit and around the right side of the chest; Soreness wrapped around under my armpit, right arm, chest area, not debilitating; sore ribs; light headed; soreness in my scalp/when I touch my head, it just feels sore; sniffles; soreness in my back below my shoulder blade/back pain below right shoulder blade towards the mid-back; soreness in my back below my shoulder blade; pain; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EN6206; Expiration Date: 30Jun2021), via an unspecified route of administration on 21Mar2021 (at the age of 66-year-old) as dose 2, single for COVID-19 immunisation. Medical history included retreatment of root canal from an unknown date performed a couple of days before first dose of Pfizer COVID-19 Vaccine administered. He did not take any pain killers prior to the first dose of Pfizer COVID-19 Vaccine, and did not take any antibiotics prior to that first dose of Pfizer COVID-19 Vaccine, sharp pain in the back, which was isolated pain from an unknown date and due to that the patient wasn't able to sleep. Concomitant medication included amoxicillin taken for oral infection due to root canal 28Feb2021 to 07Mar2021. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EN6203; Expiration Date: not reported), via an unspecified route of administration on 28Feb2021 (at the age of 66-year-old) as dose 1, single for COVID-19 immunisation and had lightheaded, slight headache and also received Shingles vaccine, 2 doses, which were maybe 1 year ago or so, before the pandemic, he felt pretty crummy for 3-4 days and he was unable to provide lot number, or expiration date. The patient experienced light headed on 21Mar2021, sniffles on 21Mar2021, soreness in scalp/when touched head, it just felt sore on 21Mar2021, soreness in back below his shoulder blade/back pain below right shoulder blade towards the mid-back on 21Mar2021 soreness wrapped around under his armpit, right arm, chest area, not debilitating; pain traveled under armpit and around the right side of the chest; sore back and armpit on 22Mar2021, sore ribs on 22Mar2021, got discomfort on 24Mar2021, pain in Mar2021,  , getting sick on an unspecified date. The outcome was recovered for dizziness and sniffles on 22Mar2021, not recovered for discomfort, soreness in my back below my shoulder blade, and soreness in my back below my shoulder blade/back pain below right shoulder blade towards the mid-back, soreness in my scalp/when I touch my head, it just feels sore and the outcome was unknown for rest of the events.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain of skin, Rhinorrhoea
Clinical narrative: getting sick; get discomfort; Soreness wrapped around under my armpit, right arm, chest area, not debilitating/Pain traveled under armpit and around the right side of the chest/Sore back and armpit; Soreness wrapped around under my armpit, right arm, chest area, not debilitating/Pain traveled under armpit and around the right side of the chest; Soreness wrapped around under my armpit, right arm, chest area, not debilitating; sore ribs; light headed; soreness in my scalp/when I touch my head, it just feels sore; sniffles; soreness in my back below my shoulder blade/back pain below right shoulder blade towards the mid-back; soreness in my back below my shoulder blade; pain; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EN6206; Expiration Date: 30Jun2021), via an unspecified route of administration on 21Mar2021 (at the age of 66-year-old) as dose 2, single for COVID-19 immunisation. Medical history included retreatment of root canal from an unknown date performed a couple of days before first dose of Pfizer COVID-19 Vaccine administered. He did not take any pain killers prior to the first dose of Pfizer COVID-19 Vaccine, and did not take any antibiotics prior to that first dose of Pfizer COVID-19 Vaccine, sharp pain in the back, which was isolated pain from an unknown date and due to that the patient wasn't able to sleep. Concomitant medication included amoxicillin taken for oral infection due to root canal 28Feb2021 to 07Mar2021. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EN6203; Expiration Date: not reported), via an unspecified route of administration on 28Feb2021 (at the age of 66-year-old) as dose 1, single for COVID-19 immunisation and had lightheaded, slight headache and also received Shingles vaccine, 2 doses, which were maybe 1 year ago or so, before the pandemic, he felt pretty crummy for 3-4 days and he was unable to provide lot number, or expiration date. The patient experienced light headed on 21Mar2021, sniffles on 21Mar2021, soreness in scalp/when touched head, it just felt sore on 21Mar2021, soreness in back below his shoulder blade/back pain below right shoulder blade towards the mid-back on 21Mar2021 soreness wrapped around under his armpit, right arm, chest area, not debilitating; pain traveled under armpit and around the right side of the chest; sore back and armpit on 22Mar2021, sore ribs on 22Mar2021, got discomfort on 24Mar2021, pain in Mar2021,  , getting sick on an unspecified date. The outcome was recovered for dizziness and sniffles on 22Mar2021, not recovered for discomfort, soreness in my back below my shoulder blade, and soreness in my back below my shoulder blade/back pain below right shoulder blade towards the mid-back, soreness in my scalp/when I touch my head, it just feels sore and the outcome was unknown for rest of the events.  No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Malaise, Off label use, Walking distance test, Walking distance test abnormal
Clinical narrative: patient experienced the event of did worse on her 6 minute walk; Increased to 11 breaths of Tyvaso; not been feeling well; This is a spontaneous report from a contactable consumer or other non hcp (patient) received via Pfizer from regulatory authority (Manufacturer Report No: UNT-2021-005040).A 81-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 15Mar2021 (Batch/Lot number was not reported)(at the age of 81-year-old)  as dose number unknown, single for COVID-19 immunization, treprostinil sodium (TYVASO, concentration of 0.6 mg/ml) delivered by Tyvaso inhalation device (TD-300/A) (device only) via an inhalation route of administration from 04Jan2021 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose, via inhalation route of administration from an unspecified date (Batch/Lot Number: 2101910; Expiration Date: 31Oct2021) to an unspecified date, at 18-54 microgram, four times a day and via inhalation route of administration from 15Mar2021 (Batch/Lot number was not reported) to an unspecified date, at 66 microgram for pulmonary arterial hypertension. Medical history included ongoing pulmonary arterial hypertension. Concomitant medications included sildenafil citrate and diltiazem hydrochloride. On 15Mar2021, patient experienced increased to 11 breaths of tyvaso and not been feeling well. On 18Mar2021, patient experienced the event of did worse on her 6-minute walk. It was reported that on 15Mar2021, 2 months 12 days after initiating IH Tyvaso the patient had not been feeling well and the patient got her Covid-19 vaccine and she increased to 66 microgram (11 breaths) of IH Tyvaso (off label use) on the same day. On 18Mar2021 (Yesterday), 2 months 15 days after initiating IH Tyvaso, the patient did worse on her 6-minute walk test at physician visit. The patient underwent lab tests and procedures which included walking distance test: worse on her 6-minute walk on 18Mar2021. The action taken in response to the events for treprostinil sodium was unknown. The outcome of the events was unknown.  The reporter's causality for the event malaise with IH Tyvaso was considered to be possibly related. The reporter did not provide causality for the event of walking distance test.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: I am receiving some sure pain in my foot; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of unspecified age and gender received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection with Lot Number: ER8732; Expiration Date: 31Jul2021), via an unspecified route of administration on 25Mar2021 as dose 1, single for COVID-19 immunisation. Co-suspect product included clopidogrel bisulfate (PLAVIX) taken for anticoagulant therapy. Medical history included foot amputation surgery that he had month and half ago before vaccination. The patient experienced some sure pain in his foot on an unspecified date and wanted to know if that was because of the dose or not. The event outcome was reported as unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Malaise, Pain
Clinical narrative: bad as well; fatigue; injection site pain; pain; This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc (Case Number: 01893875).   A female patient of an unspecified age received BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 18Feb2021 as dose 2, single for covid-19 immunization; pembrolizumab (KEYTRUDA, Batch/Lot number was not reported) via an unspecified route of administration from 10Mar2021 to an unspecified date, at unspecified dose and frequency for an unspecified indication. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunization. The patient experienced fatigue on 11Mar2021 with, bad as well on 22Mar2021, injection site pain and pain on an unspecified date in 2021. It was reported that patient had her 2nd Pfizer COVID vaccine on 18Feb2021 "she did well", and on 10Mar2021 she received her "4th or 5th" treatment with keytruda. Patient has not had any problems with keytruda however, experienced fatigue on 11Mar2021, extreme fatigue on Friday 19Mar2021 and yesterday 21Mar2021, and today 22Mar2021, was bad as well. she has experienced injection site pain and intense pain all over however, could not recall when these symptoms started. since the Keytruda therapy on 10Mar2021 patient "has gone downhill" and was unsure which medication caused these side effects. The action taken in response to the event for pembrolizumab was unknown. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Mucous stools
Clinical narrative: Mucus on the stool in the day following the vaccine.  Multiple instances (5+); This is a spontaneous report from a contactable consumer (patient).  A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number and expiry date: not reported) via an unspecified route of administration on 30Mar2021 at 16:30 (Age at vaccination: 46-year-old) on left arm as dose 1, single for Covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was neither diagnosed with Covid-19 prior to vaccination, neither been tested for Covid-19 since the vaccination. Medication history included: Penicillin allergy. Concomitant medications included: semaglutide (OZEMPIC), Levothyroxine, and Atorvastatin (within 2 weeks of vaccination). On 31Mar2021 at 10: 00 Am, the patient had Mucus on the stool in the day following the vaccine. Multiple instances (5+). The patient did not receive any treatment for adverse event. Outcome of event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Fatigue, Nipple pain, Pain, Pain in extremity
Clinical narrative: tired; body was sore; nipples have been sore/nipples on my breast are tender; breast is still sore; arm was sore; This is a spontaneous report from a contactable consumer (herself). A 54-years-old non pregnant female patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number: EP6955), dose 2 via an unspecified route of administration, administered on Arm Left on 25Mar2021 10:45 as DOSE 2, SINGLE for covid-19 immunisation (at an age of 54 years). Medical history included lung neoplasm malignant from an unknown date and unknown if ongoing and contrast media allergy (Iodine with contrast) from an unknown date and unknown if ongoing. Concomitant medication included drospirenone (SLYND) and patient had green pills after dose 2 of vaccination. The patient previously took bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL3247), dose 1 via an unspecified route of administration, administered on Arm Left on 03Mar2021 14:15 as DOSE 1, SINGLE for covid-19 immunisation received other vaccines within 4 weeks prior to this COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. No medications received within 2 weeks of vaccination. The patient took her second vaccine on Thursday. The next day about 23 hours later on 26Mar2021 at 11:00 she felt very tired and her body was sore. Her concern is that her nipples have been sore since Friday. She took Slynd 4mg everyday. She was concerned because her breast has not been sore in the past. Today is Monday, March 29, 2021 and her breast is still sore if she touch it. Note: on 26Mar2021 her arm was sore with both shots which she know is a normal side effect. Also, she aware that being tired and her body being sore is another side effect. Her concern is that her nipples on her breast are tender. This is something new that she have not experienced in years. No treatment measures were taken in response to events. The clinical outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chills, Gait disturbance, Loss of libido
Clinical narrative: Chills; Staggering at times; Could not get out of bed for some time; Lack of sex drive; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization; leuprorelin acetate (ELIGARD), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 7.5 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. On unspecified date the patient experienced chills, staggering at times, could not get out of bed for some time, and also stated, the patient had all of the side effects (including lack of sex drive). The patient did not feel the vaccine was related to side effects. The outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Patient had pre-existing tinnitus but it was very slight.  After receiving the COVID vaccine, he told her the tinnitus (ringing in ears) got much more severe; This is a spontaneous report from a non-contactable consumer. A male patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history included tinnitus from an unknown date and ongoing. Concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Any other vaccines taken within four weeks prior to the vaccination was not reported. On an unknown date, the patient experienced tinnitus but it was very slight. After receiving the COVID vaccine, the tinnitus (ringing in ears) got much more severe. The patient had a pre-existing tinnitus but it was very slight. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event tinnitus (ringing in ears) got much more severe was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Headache, Nasopharyngitis, Pain
Clinical narrative: Pain; Head was hurting; I thought was like cold coming up; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified gender and age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/lot number: Unknown, Expiry Date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization: Paracetamol (TYLENOL, Lot number: unknown, Expiry date: Not reported) via an unspecified route of administration on an unknown date unknown dose and frequency for pain killer and unknown if ongoing. The patient medical history and concomitant medications were not reported. It was reported that on an unspecified date patient experienced Pain. Patient stated "I had a (Pfizer, Covid-19) Vaccine shot 2 days ago, I took a Tylenol pain killer (might have pain after shot) yesterday (24Mar2021). Reporter queried that would that effect. "I took some, my head was hurting, so I took Robitussin and I thought was like cold coming up" on an unspecified date. Therapeutic measures were taken as a result of the events Pain, Head was hurting. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: UNK
Symptoms: Chest pain, Malaise, Pain in extremity
Clinical narrative: sore arm; felt a little unwell; potential drug interaction; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. Patient received aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date for chest pain. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. Patient reported that she was having some chest pains and took aspirin 30 minutes before the vaccine. The patient experienced sore arm and felt a little unwell on an unspecified date. The patient was seeking guidance on how this would affect the vaccine there was potential drug interaction. The outcome of all the events was not unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Infectious mononucleosis
Clinical narrative: diagnosed with Mono today; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on an unspecified date (at the age of 18-year-old), as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had first dose and due for the second dose next Wednesday. On unspecified date patient was diagnosed with Mono (today). The Urgent Care doctor said it would be fine to go get it. Her Primary said to wait a couple of weeks. Reporter asking can she got the second dose of vaccine and would the second dose be less effective if patient waited for second dose. The clinical outcome of the events was unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.