chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had the Pfizer Vaccine on 22Mar2021 and had the 2nd dose of the vaccine today; a little soreness in the arm from getting the shot; Hers is just a little tender; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0185), via an unspecified route of administration in the left arm on 09Jul2021 at 12:15 (at the age of 50-year-old) as dose 2, 0.3 ml single for COVID-19 immunisation in pharmacy. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6198), via an unspecified route of administration in the left arm on 22Mar2021 (at the age of 50-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that she was called about the Pfizer Vaccination and stated she and her husband both had the Pfizer Vaccine on 22Mar2021 and then had hesitancy about getting the 2nd dose of the vaccine but both she and her husband did get the 2nd doses of their vaccines today at "PRIVACY"; she had some question about the amount of time between the two doses of the Pfizer Vaccines for herself and for her husband about whether or not they were within the amount of time Pfizer recommends and to they need to start over with the 2nd shots being their 1st shots. Caller said that she was having a little soreness in the arm from getting the shot. She said that her husband does not even have that. She was just a little tender. She wanted to know "Has Pfizer provided a statement on the need for a booster dose (3rd dose) and Is Pfizer investigating the need for a booster dose. Response: As part of Pfizer's and BioNTech's continued efforts to stay ahead of the virus causing COVID-19 and circulating mutations, the companies provided an update on booster dosing on 09Jul2021. Please note that the use of a 3rd or booster dose is not recommended or authorized, and Pfizer does not suggest the use of the vaccine in any manner other than as described in the authorized EUA Prescribing Information authorized product monograph. Initial data from the ongoing study of booster doses demonstrated a consistent tolerability profile and high neutralization titers against the wild-type virus (the naturally occurring non-mutated virus) and the Beta variant. It was thought that the effects seen against the Beta variant may also be seen in the Delta variant. We are doing studies to confirm this. We expect to publish the data soon in a peer-reviewed journal and submit to regulatory authorities like the FDA in the coming weeks. The adverse events did not result in visit to emergency room and physician office. The outcome of the events was not resolved.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021868964 Same product and event, different patients
Flu like symptons came on immediately (approximately 8 hours after vaccine).  Headache, muscle aches, fever, shivering, fatigue
8/14/21: Patient recently exposed to someone with COVID, and developed shortness of breath, cough, and diarrhea for past 2 days. admitted. Diagnosed with COVID-19 pneumonia, acute hypoxic respiratory failure, acute COPD exacerbation secondary to acute viral infection 8/24/21: medically cleared to skilled nursing facility and discharged. Note: She stated she was vaccinated  with Pfizer in Feb and March 2021. (However, record shows her vaccination was on 1/16/21 and 2/13/21. Unable to confirm as she did not have her vaccination card).
Fever (shivering cold despite wearing warm clothes and heat in the house).  Brain fog (struggle to recall and act on critical thinking required for work).  Painfully swollen lymph node in left armpit (Covid booster provided in left arm)
Pt said that she got dizziness and swelling of face, neck, chills in November 2014 and she visited ER 1 month after inj. ER was unable to determine the cause of dizziness and recomm pt to go to primary MD. Primary MD unable to find cause. Pt also complain of pain at inj. site even after a month. Pt still has weakness in arm where she got injection. Pt also develop dizziness approximately 1 month after inj. in Nov and got worst in December 2014. Pt said got rash/itchiness after inj. but no known actual date (Kw/in the month).
Patient is complaining of warmth and swelling of arm starting at the injection site, with no pain.
Severe body aches, headache, low grade temp, diarrhea, fatigue Took Tyleno and Advil
New onset R facial droop 7/17/05 ER. In June had seizure.
Manufacture's package: One 5ml multiple dose vial (10 doses). A single dose (0.5ml). On 12/22/2022, 10 full doses was administered to 10 patients. RN administered left over from the vial as a full dose to the 11th patient.
Subacute Degeneration of the Spinal Column; Chronic Idiopathic Axonal Polynueropathy; Change in taste; inability to feel many bodily nerves; constantly in pain and numbness.
Tip of the tongue erythematous with sores and blisters all over the tongue and inside part of lower lip
allergy symptoms; reactive airway; This is a spontaneous report received from a contactable physician (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES).   A 49-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration, administered in left arm on 21Jan2021, at 13:15 as single dose  for covid-19 immunization at the age of 49-years.  The patients medical history was not reported.  There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  No allergies to medications, food, or other products were noted.  The patient previously took BNT162B2 for covid-19 immunization on 04Jan2021 as the first dose in the left arm.  The patient experienced allergy symptoms and reactive airway on 25Jan2021 with outcome of recovering. The events were described as significantly increased allergy symptoms, never previously experienced, unrelenting for last six weeks with reactive airway, now present, and significantly improved with prednisone and inhalers.   The patient underwent lab tests and procedures which included nasal swab that was negative  on 27Jan2021; COVID-19 virus test had  unknown results on an unspecified date.  Therapeutic measures were taken as a result of reactive airway as aforementioned. The outcome of events, allergy symptoms and reactive airway was recovering.
Expired Vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had never been diagnosed with/ tested positive for COVID 19. Acute illness at the time of vaccination and up to one month before was reported as none. Chronic or long standing health conditions were reported as none.  Concomitant medications details were not reported by the reporter.  Patient had received booster dose.  It was reported that patient had experienced no side effects when vaccine was administered and no side effects reported or noticed afterwards  The vaccine was moved from freezer to refrigerator the day of administration.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2022: Follow-up received on 17-Jul-2022 included updated Reporter details, patient demographics details added and narrative updated On 17-Jul-2022: Follow-up received on 17-Jul-2022 included Non-significant follow up appended
Patient received Pfizer COVID vaccine at approximately 0850. Patient instructed to wait 15 minutes after receiving vaccine. Observer reported to administering RN that patient was having symptoms of a reaction. RN immediately spoke with patient regarding statements. Patient stated he had tingling in his neck and then tightness along his mediastinum immediately following tingling. Vitals taken by RN at 0905. BP 164/84, P 108 and O2 98%. Tightness began to subside after approximately 5 minutes. Patient asked to stay an additional 30 minutes for observation. Vitals taken again at 0920. BP 144/82, P85 and O2 sat 99%. Patient stated he was no longer experiencing tightness of tingling at that time. Patient discharged from clinic and advised to contact his PCP before receiving second dose of Pfizer COVID vaccine.
A week after dose 3, my right elbow and then left elbow I was unable to lift anything. It began with trying to lift my kettle. This gradually progressed and got worse and lasted about 4 months. I began to subside but was intermittent. The pain was like they describe as "tennis elbow". I was in another country when this was happening and was unable get care. I was unable to rest my arm without having pain. I have taken ibuprofen to mask the pain but I have not found the cause for the pain. When I returned home I was unable to see a doctor. The pain has subsided enough now that I may not see one for this. Also, in September 2022, I began to have fever like symptoms and a migraine-like headache. I was in another country when this happened. I had a low-grade fever. I had sore throat, headache, classic flu-like symptoms. I tested positive for COVID-19 with a home test on September 8, 2022. I took the prescription antiviral, cefixime in another country, SUPRAX at home, prescribed in other country. I tested negative on September 18, 2022.
legs are hurting and is having body pain; muscle pain; joint pain; nauseous; legs are hurting and is having body pain; vomiting; diarrhea; lost his appetite; headaches; chill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 08Jul2022 as dose 1, single (Lot number: FN2908) at the age of 35 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: CHILLS (non-serious) with onset 09Jul2022, outcome "not recovered", described as "chill"; DIARRHOEA (non-serious) with onset 09Jul2022, outcome "unknown", described as "diarrhea"; HEADACHE (non-serious) with onset 09Jul2022, outcome "not recovered", described as "headaches"; PAIN IN EXTREMITY (non-serious) with onset 09Jul2022, outcome "not recovered", PAIN (non-serious), outcome "unknown" and all described as "legs are hurting and is having body pain"; DECREASED APPETITE (non-serious) with onset 09Jul2022, outcome "recovered", described as "lost his appetite"; VOMITING (non-serious) with onset 09Jul2022, outcome "not recovered"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; NAUSEA (non-serious), outcome "unknown", described as "nauseous". Therapeutic measures were taken as a result of pain in extremity, pain, vomiting, diarrhoea, decreased appetite, headache, chills, myalgia, arthralgia, nausea.  Additional information: Reporter had the first dose this past Friday, has been experiencing vomiting, diarrhea, leg pain b/l and loss of appetitive, and headache that hasn't gone away. Some side effects that have been reported was headache, muscle pain, joint pain, diarrhea, vomiting, nauseous. Loss of appetite was not mentioned in the reported side effects. These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials; Persons 18 Years and Older: Systemic reactions usually lasted around 1 day. When clarifying that the reporter was calling regarding the Pfizer Covid-19 vaccine and not Paxlovid, transferring agent states that patient was actually calling from support line as previously stated. Reporter states patient was having diarrhea, headaches and chills, legs are hurting and is having body pain. Adverse Event: diarrhea, headaches and chills, pain in both legs, loss of appetite; Time of Onset: 9Jul2022.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. The reporter stated that on an unknown date multiple unspecified patients were vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (therapy type: Digital Data Logger) (lot # L016428 with an expiry date of 30-JUL-2017, lot # L044475 with an expiry date of 21-MAY-2017 and lot # L001312 with an expiry date of 24-FEB-2017), at a temperature of 51 F for a time frame of 5 years (incorrect product storage). There was a previous temperature excursion reported for GARDASIL 9 at a temperature of 59 F for 29 hours. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested.
ACUTE ST ELEVATION MI, LEFT ANTERIOR DESCENDING CORONARY ARTERY 4/24/2023 HTN (HYPERTENSION) ACUTE ST ELEVATION MI, LEFT ANTERIOR DESCENDING CORONARY ARTERY 4/24/2023 HTN (HYPERTENSION)
Same day post vax, this pt presented to a medical center with flu-like symptoms and epigastric burning. He was treated with ranitidine. His symptoms worsened, he developed shortness of breath, was hospitalize in ICU with a dx of dilated cardiomyopathy. He required balloon pump support and will require a heart transplant.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional information was provided as follows: The age at vaccination was not reported. The reporter reported that all the women at her seniors group experienced pain and redness at the injection site for at least a week after getting SHINGRIX.  The reporter consented to follow up.
Pt and mom standing at the nurses station waiting for updated vaccination record when all of a sudden a thud was heard. Pt was on the floor and asked mom why did you push me mom repeatedly. Mom stated honey I didn't push you, I think you fainted. Pt was then taken to an exam room vitals obtained and wnl, a cool cloth was given to pt and pt is now resting on the exam table with mom at her side. The reaction took place about 5 minutes after receiving the vaccine.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drug reactions and allergies were not provided. On an unknown date in 2014, the patient was vaccinated with ZOSTAVAX (dose, route, lot # and expiration date were not provided). It was reported that the patient was vaccinated with ZOSTAVAX 3 years ago and was now experiencing shingles on an unspecified date. The outcome of shingles was unknown. Causality was not assessed by the physician. Additional information has been requested.
No erythema or swelling at inject site. Decreased flexion of left leg by 30 deg. No tender, pink medial and swelling superior to knee right thigh 24.5 cm, left thigh 28.5 cm denies trauma. Dx cellulitis, Tx with Keflex 500 MG PO BLD x 7 days, Benadryl 1.5 TSP Q 4-5 PR
Pt developed Varicella infection; < 50 lesions all over body, oral lesions, with fever; but crop of 10-15 vesicles grouped around vaccine site in thigh.
Marked swelling, erythema and pain at injection site within 3-4 hours after injection.  About 20 cm wide.
Sore arm started at 4:00pm. Very sore but manageable.  Nocturnal diarrhea started at 5:00am, 6:00am and 8:00am  on 3/4/21. Very urgent. Reoccurrence 3/5/2021 at 1230am and 2:00am
This is a spontaneous report from a contactable physician. A child (age and gender unknown) received the 4 dose series of PREVNAR 13, at 1 DF. Relevant medical history and concomitant medications were not provided. The patient received the previous 3 doses of PREVNAR 13 on unspecified dates. The physician reported that the serotype analysis shows an incomplete response. Therapeutic measures taken for the event were unknown. The outcome of the event is unknown. Follow-up (13Jan2012): Follow-up attempts completed. No further information expected.
Severe chills, weakness in legs, sweating, soreness at injection site. Only the soreness extended past 24 hrs from injection; soreness continued for multiple days.
This spontaneous report was received from a Medical Assistant, referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 04-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L042265; expiration date: 26-OCT-2017, (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. The vaccine underwent a temperature excursion (10F) for a time frame of 3 hour 16 minutes. No previous temperature excursions were reported. This is one of several reports from the same reporter. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 06-OCT-2009, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about May 2016, the patient was treated by a physician and was diagnosed with herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
pt recv vax 5SEP97 & 5SEP97 pt devel urticaria described as hives & welts on abd, thigh, forehead & arm;pt otherwise doing fine;
My work had a nurse come in to administer a TB skin test (the kind with the needle) to those of us who needed it on 4/12/05.  On 4/13/05 several indivuals who had received the test had adverse local reactions.  It was discovered by the school office staff that the nurse had mixed up the vaccines and inadvertently given us a Td tetnus shot under the skin instead of the TB test.  (This was of immediate concern to me because only six days earlier on 4/6/05 I received a Td booster shot intermuscularly after I was bit.  Aside from the usual muscle pain at the site of the injection I had no side effects at all to this first shot.)Immediately following the mistaken injection I noticed pain in my arm and muscle soreness and sharp shooting pains.  The shooting pains dissipated after 24 hrs.  On 4/13/05 I noticed intense itching at the site of the injection and swelling about 1 inch in diameter.  On 4/14/05 the swelling dissipated but I became physically ill. At 5pm PST I began sweating and shivering but had no fever.  I felt ligthheaded and dizzy and was unsteady on my feet.  At 7pm I took a nap and didn't wake up until 8am the next morning which is unusual for me.  All day on 4/15/05 I felt dizzy, lightheaded, extremely tired.  My whole body hurt and my muscles felt weak and sore.  I was unsteady and shaky.  I felt like I was walking uphill through quick sand.  My chest felt tight like there was an elephant sitting on it.  I continued to alternate between sweats and chills but still had no fever.  I also felt anxious and moody.  All I wanted to do was sleep but could not because I was working.  That evening I also experienced brief bouts of hyperventilation and difficulty catching my breath.  On 4/16/05 I missed work and slept all day.  I still felt like I had no energy and my body was sore and weak and I was dizzy.  This general feeling continues today although I am managing to stay awake and accomplish work.  I have also noticed a dramatic weight loss despite eating as I normally do.  I have lost between 3-5 pounds since 4/6/05.
Idiopathic thrombocytopenic purpura; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 19-Jan-2021 due to IMMUNE THROMBOCYTOPENIA. At the time of the report, IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       One day after the patient's first dose, the patient woke up with bruises on the arms and legs, and had blisters that bled inside mouth. The patient was admitted to an unspecified hospital on 19Jan2021 with a severe case of idiopathic thrombocytopenic purpura. Concomitant and treatment information not provided  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
pt recv vax & 6 hrs later devel a pruritic (hives) rash w/facial swelling; no joint involvement; 5 days later has hives & erythema multiforme