chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 77-year-old male patient received BNT162b2 (BNT162B2), on 05Nov2021 at 10:00 as dose 3 (booster), single (Lot number: FH8030) at the age of 77 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: BNT162b2 (Dose 2, Batch/Lot No: EN6198, Location of injection: Arm Right, Vaccine Administration Time: 09:00 AM), administration date: 27Feb2021, when the patient was 77-year-old, for Covid-19 immunization; BNT162b2 (Dose 1, Batch/Lot No: EL9269, Location of injection: Arm Right, Vaccine Administration Time: 09:00 AM), administration date: 06Feb2021, when the patient was 77-year-old, for Covid-19 immunization. The following information was reported: COUGH (non-serious) with onset 01Dec2021, outcome "not recovered", described as "Coughing"; PRODUCTIVE COUGH (non-serious) with onset 01Dec2021, outcome "not recovered", described as "Flem in throat"; NASOPHARYNGITIS (non-serious) with onset 01Dec2021, outcome "not recovered", described as "I have Cold Symptoms but have no Cold"; RHINORRHOEA (non-serious) with onset 01Dec2021, outcome "not recovered", described as "Runnie Nose"; SNEEZING (non-serious) with onset 01Dec2021, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nasopharyngitis, rhinorrhea, cough, productive cough, sneezing. Additional information: The patient had not received any other vaccine within 4 weeks prior to the COVID vaccine. The patient had received other medications Lisinopril 20 mg TAB within 2 weeks of vaccination. Reporter stated, I have Cold Symptoms but have no Cold. Runny Nose, coughing, flem in throat and sneezing. This has been going on sense my last shot on 05Nov2021. I have tested negative for Covid, Sep2021. Still have Symptoms but feel fine. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination. Patient had no known allergies. No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a nurse practitioner concerning a 4 month old patient of unknown gender. On 02-JUL-2013, the patient was inadvertently vaccination with a dose of PNEUMOVAX 23 (lot number, expiry date and dose unspecified), intramuscularly instead of the second dose of PREVENAR 13 series. On 09-MAY-2013, the patient had vaccinated with the first dose of PREVENAR 13 (lot number, expiry date, dose and route unspecified). Concomitant therapy included (unspecified), (reported as DTaP) (lot number, expiry date, dose and route unspecified) administered on 02-JUL-2013. On 02-JUL-2013, (unspecified) (reported as DTaP) site became swollen and red while the patient was in the office. The outcome of the events was unknown. The relatedness for the events was unknown for PNEUMOVAX 23 and (unspecified) (reported as DTaP). Additional information has been requested.
heart palpitations, faster and fluttering after the first vaccination; heart palpitations, faster and fluttering after the first vaccination; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 01Apr2021 at 10:00 (Lot Number: EP6955) as dose 1, single for COVID-19 immunization. Medical history included allergies to penicillin and sulfa on unknown dates. The patient's concomitant medications were not reported. The patient experienced heart palpitations, faster and fluttering on an unknown date in 2021, after the first vaccination. The heart related reaction lasted 4 weeks. The outcome of the events was recovered on an unknown date in 2021.    No follow-up attempts are possible. No further information is expected.
On date of vaccination, pain developed at site of injection and pain continued up the arm from vaccine site and down the arm from vaccine site.
Within 15 minutes of vaccine, donor experienced dizziness, headache, hypotension, and LOC <30 sec.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patients medical history, concurrent condition, drug allergies and concomitant medications were not reported. On unknown dates the patients were vaccinated with improperly stored doses of VAQTA (Lot # N004274, Expiry Date : 03-APR-2018) (Strength, dose and route of administration were not reported) for prophylaxis, which experienced a temperature excursion between 47° Fahrenheit to 77° Fahrenheit for 30 minutes. It was unknown if there was previous temperature excursions. Data logger was not involved. There was no product quality complaint involved. No adverse effects were reported (incorrect product storage and no adverse event). This is 1 of 4 reports from the same reporter.; Sender's Comments: US-009507513-1707USA008614:
Patient described the appearance of tiny red dots all over his body, similar to hives. Patient said these do not hurt, but itch slightly.
The day after patient received this vaccine he was unable to maintain a healthy oxygen level, which was a huge change from days prior to the vaccine. His ability to perform daily tasks was greatly hindered such taking a shower, brushing teeth, walking to the bathroom. He had to increase his Oxygen flow up to 7 to 8 and he still was not able to maintain a healthy level. He was lethargic and had no appetite. The symptoms have slowly receded after four weeks but still have not returned to the levels of the days preceding the shot. He hasn?t experienced any adverse side effects from previous vaccinations. He consulted with his pulmonologist  after symptoms began and was told that the side effects could take weeks to recover.
After the vaccine I have stronger fatigue, feeling down, joint and muscle pain that won't go away. It used to come and go but now its lasting longer to the point there is no going away. Doctor has started me on physical therapy and ordered an MRI, and blood work ordered but I have not done it yet.
Narrative:  53 year-old patient received 2nd vaccination on 3/30/21 at 12:17pm. At 12:32, self reported tingling sensation from the injection site on left arm down to fingers. No redness, swelling or any other signs and symptoms of adverse reaction reported. At 12:40 patient reported lessening of symptom and left the site.
Syncopal episode appr 5-7 mins after administration of IM Gardasil. Fell at our check out window with no alerts anyone- BP 116/80 BP normal/prior to exam 120/80 P. 92
My cancer had spread significantly.; This is a spontaneous report from a contactable consumer (Patient). A 70-years-old non pregnant female patient received second dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number EL1203), via an unspecified route of administration on 03Feb2021 (at the age of 70-year-old) in the right arm as a single dose for COVID-19 immunisation. The patient had received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number EN5318), via an unspecified route of administration on 13Jan2021 (at the age of 70-year-old) in the Left Arm as a single dose for COVID-19 immunisation. Medical history included Cancer, allergies to Latex, Stage 4 Metastatic Breast cancer. Concomitant medication(s) included everolimus (AFINITOR); everolimus. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccine in four weeks. On 04Apr2021, the patient cancer had spread significantly. The patient took chemotherapy for the event. It was reported that I have had Stage 4 Metastatic Breast Cancer for the last 4 years and have been successfully treated by oral therapies. Shortly after receiving the second Covid-19 vaccine, I had a P.E.T. scan, the results of which showed my cancer had spread significantly. My question is this. have you had any other adverse effects from other cancer patients? Also, did Pfizer have sufficient data on the results of their vaccine on cancer patients. I find it remarkable that I was doing so well for so long and then all of a sudden, after the vaccine, my cancer "blew up". Coincidence? Device Date: 18May2021. The patient underwent lab tests and procedures which included PET Scan with result which showed my cancer had spread significantly on an unspecified date, sars-cov-2 test with negative result on 20Apr2021.The outcome of the event was not recovered.  Follow-up (19Jul2021): 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 completed. No further information is expected.
Initially and days after the injection, I had notable pain at the injection site (which I understand is typical of this vaccine).   About 12 hours after receiving the injection, I also experienced notable feelings of fever, nausea and restlessness.  The next two days I experienced significant fatigue with dizziness.  On 8/3/2019  I went to Urgent Care and was recommended to go to ER that same day.  At the ER I was given IV fluid and Meclazine.   No definitive diagnosis related to the Shingles injection was documented but there were no other circumstances  related to these symptoms.  I am convinced this was a reaction to this injection.
- Typical sore arm and fatigue in Day 1 & 2 - 4 days of severe headache from Day 1 through Day 4 - Day 4 severe diarrhea - Day 4 & 5 foggy "brain" - Muscle aches and weakness Day 2 - 4 - Potential menstrual period interruption
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain in arm and product supply issue. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: After receiving the first dose of SHINGRIX, the patient's arm was sore for a week which was part of the reason she waited until closer to six months. The patient was told to come back within 2 to 6 months to receive the second dose of SHINGRIX. Two weeks ago, from the date of reporting, the patient went back to pharmacy where she received the first dose and they told her that it was on backorder and hundreds of people were ahead of her. The patient asked if those that had the first vaccine received a priority and she was told no. The patient asked the pharmacist when she could receive her SHINGRIX shot and he said she might need to get two more shots. The patient doesn't want to start the series over again. The patient called another pharmacy and they told her they did give anyone who had the first shot a priority. The patient asked is the 6 months critical to the effectiveness of the vaccine or could it be a longer time and could you influence pharmacies to give priority to those that had already had first shot. The patient reported that it sounds like they don't even have any vaccine to distribute. This case has been linked with case US2018GSK232257, reported by same reporter.
Severe chronic diarrhea and weight loss due to the diarrhea. Cannot hold stools. Total liquid stools no form.
hematoma; bruising in the left arm; really hurt; she had limited use and could only raise it so far.; This is a spontaneous report from a Pfizer sponsored marketing Program COVAX US SUPPORT a stimulated report reported by contactable consumer (reported for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm right on 09Feb2021 as 2nd dose, single dose and dose 1 via an unspecified route of administration, administered in arm left on 17Jan2021 as 1st dose, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. States she received her first dose of the Pfizer Covid-19 vaccine on 17Jan2021 in her left arm. States she developed a hematoma on an unspecified date in 2021 immediately after administration that soon settled into a bruise. States that she received her second dose of the Pfizer Covid-19 vaccine 09Feb2021 in her right arm due to the bruising in the left arm on an unspecified date in 2021. On an unspecified date in 2021, states the left arm "really hurt" and that she had limited use and "could only raise it so far." States she was on workman's comp light duty and has been told not to use her left arm. States she sought out medical attention and had two sets of Xrays due to her arm pain. States the first set of Xrays showed nothing abnormal, but the second set of Xrays show "what looks like cottage cheese right in the middle of the deltoid muscle." The consumer clarifies and confirms that it was not a bruise, it was something growing in her arm, it came up on the x-ray. She had no issues at all at first dose. After she had the first injection, it was a giant hematoma at the injection site and people said it would go away with heat, so she did. When she went to get her second dose, her left arm was still bruised from the previous shot. She decided to get the second dose in the right arm because of this. The left arm still hurt, and something was wrong with it. She went to work man's comp and they sent her out to an orthopedic guy, and they took an x-ray. The x-ray showed that there was something growing at the injection site in the muscle. The first set of x-rays showed nothing, but the second one showed that there was something in the muscle. The outcome of the events was unknown.  Information about Lot/Batch number are requested, additional information requested.
Massive chest pain, went to urgent care told it was anxiety sent home, went to ER later due to increased pain in lower chest where ribs meet stomach, ended up with elevated ECG, then proceeded to be give anti-anxiety and a Troponin level check. Troponin was over 5 ng/mL admitted to hospital after an Echo which resulted in an MRI the next day and concluded that it was likely Myocarditis.
itching on the hands; This is a spontaneous report from a contactable consumer (parent). A 12-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0168; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in Arm Right at 4:10-4:5pm on 18May2021 as SINGLE DOSE for covid-19 immunisation. Reporter states the patient got 1st dose was 18May2021, lot EW0168, in her right arm before tennis practice at 4:10-4:5pm that on the sticker she had to wear it said 4:35 to leave after dose. States the expiry date is 31Aug2021. Caller does not have the NDC or dose to provide. Medical history included meningitis at 7 years old. she had meningitis and went through a whole lot with that and doesn't think that has a bearing on this. There were no concomitant medications. Patient had not taken other products. Patient's historical vaccine include Flu shot. Patient does the flu shot every year. Vaccines administered on same date of the Pfizer suspect reported as none. Patient was not received any other vaccine prior four weeks of vaccination. On an unspecified date the patient experienced itching on the hands. Reporter states her school gave her the 1st dose on 18May2021. Caller reported with her first does of the vaccine, she had itching on the hands but didn't thought about it and perhaps that was a sign after the first dose. Reporter relays her daughter didn't have anything weird after her 1st dose. After her 1st dose her hands itched, and she didn't pay it any mind. States she had no face swelling. Reporter states she is wondering if those little hand itches after the 1st dose she didn't talk about till now was that a little bit of a sign that something else was there. States she didn't mention it after the 1st dose and was good to go. States after the 2nd dose she said reporter that her hands itched after the 1st dose, her lip didn't swell, and she told the doctor it's not conditions on the list of symptoms and she didn't have breathing issues. Caller states it's a non-severe reaction and is assuming to dose and said yesterday if she gets a booster what does Pfizer advise. Caller states she doesn't over react but she is aware and if she had told her about her hands she would have thought allergic reaction, mild one and brought her to the doctor or at the 2nd vaccine and she didn't say anything until after the fact. Patient visited to physician's office for the events. The outcome of the events was reported as unknown.   Follow up attempts are needed; further information was requested.
This spontaneous report as received from a 69 year old pharmacist regarding himself. Pharmacist reported that on unknown date in 2013, he administered himself with ZOSTAVAX, dose (unknown), frequency (unknown), subcutaneous, in the abdomen, for unknown indication. No concomitants were reported. On an unknown date, the patients whole abdomen became red. The outcome of was reported as recovered. Causality assessment was not provided. Oharmacist declined to answer any additional information questions about him. No further information was provided. This report is linked to 1402USA006892, 1402USA007824 and 1402USA007826 by the same reporter link. Additional information has been requested.
My shoulder was very itchy, and it was so painful I couldn't even lay on my arm at night, so I called my doctor and went to an office visit. I was told that was Bursitis. So, I made an appointment with my Orthopedic Doctor. My arm was getting worse, so he gave me an injection into my bursa. It got worse so I eventually had to have surgery on 11/8/2021.
Hives and a fever- it lasted about 2 hours. Went away on its own, no medication needed.
This case was reported by a consumer and described the occurrence of feeling unwell in a 90-year-old female patient who received BOOSTRIX. Concurrent medical conditions included chronic obstructive pulmonary disease. Concomitant products included LIPITOR, Blood Pressure Med and SYNTHROID. On 5th January 2015 12:00, the patient received BOOSTRIX (injection) .5 ml. On 7th January 2015, 2 days after receiving BOOSTRIX, the patient experienced feeling unwell, dry cough, influenza-like symptoms, fatigue, general body pain and fever. In January 2015, the patient experienced cold symptoms and cold. On an unknown date in January, the patient experienced rib pain and sore throat. On an unknown date, the outcome of the feeling unwell, dry cough, influenza-like symptoms, cold symptoms, fatigue, rib pain, sore throat, cold, general body pain and fever were not recovered/not resolved. The reporter considered the feeling unwell, dry cough, influenza-like symptoms, cold symptoms, fatigue, rib pain, sore throat, cold, general body pain and fever to be almost certainly related to BOOSTRIX. Additional information: The caller reports that his mother in law received the BOOSTRIX vaccine on Monday, January 5, 2014. She started to experience adverse events on Tuesday. He reports that she is feeling fairly sick, has body aches, dry cough, flu like symptoms, feels like she has a low grade fever, fatigue, her ribs are hurting, has a sore throat, has a cold, and has cold-like symptoms. The caller reports that her side effects are unchanged as of right now.
Appendicitis noninfective  / Serositis of the Appendix; Lot of pain; Dose 3 was administered on 19Aug2021; Dose 3 was administered on 19Aug2021; This is a solicited report based on information received by Pfizer from AbbVie (Manufacturer Control Number 21K-163-4104056-00) via a contactable consumer (patient).     A 51-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 19Aug2021 (Batch/Lot number was not reported) (at the age of 51 years old) as dose 3 (booster), single dose for Covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe hidradenitis suppurativa, and moderate to severe rheumatoid arthritis. The patient medical history was not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Mar2021 via intramuscular (at the age of 50 years old), and the second dose on 28Apr2021 via intramuscular (at the age of 50 years old), for Covid-19 immunization. The patient's concomitant medications were not reported. The patient previously took codeine, levaquin, and amoxicillin and experienced allergy. The patient experienced appendicitis noninfective/serositis of the appendix on an unspecified date. The patient had an emergency appendectomy for serositis of the appendix. The patient had a lot of pain on 19Aug2021. The action taken in response to the events for adalimumab was unknown. Outcome of the events was unknown.  Sender Comment: AbbVie's opinion is that there is no reasonable possibility that the events of Serositis of the Appendix and after receiving third Covid shot had lot of pain are related to HUMIRA (ADALIMUMAB).  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow up attempts are possible. Information on Lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events appendicitis, pain, off label use and booster dose and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient was given vaccine that exceeded the 45 days allowed in the refrigerator. No symptoms were reported and patient was notified of the error
Information has been received from a physician concerning an 85 year old female consumer who's husband was diagnosed with shingles on 11-JAN-2008, who on 15-JAN2008 was vaccinated with zoster vaccine live (Oka/Merck). On 29-JAN-2008, the patient developed a few spots on her body, location not provided. On 30-JAN-2008, she had more spots. Medical attention was sought in the office, there were no lab studies performed. The patient was diagnosed with varicella. The patient recovered on an unspecified date. There was no product quality complaint involved. Additional information has been requested.
After the vaccine I started feeling tingling in left face and in the left corner of the eye. It was mild and went away by 11.30 pm and in the morning next day it was all fine. I just wanted to mention to ensure if second dose is fine
Red splotchy rash and arm sore, area with rash irritated and sore. Began 2 days post injection. has continued on 4/20/2021