chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient returned 40 minutes after receiving the vaccine being driven by his daughter. Patient was diaphoretic, pale, and non-responsive. Sternal rub produced no reaction.  Instructed daughter to take patient to ER (which is right down the road).  Patient was hypotensive upon arrival to ER. Treated patient with bolus fluids, put in Trendelenburg, gave 0.3mg of epinephrine IM, 125 solu-medrol, 25 benadryl IV, and 40mg Pepcid IV. Patient was noted to improve after dosing with these medications. Patient was monitored for 3 hours in ER. Was sent home on Benadryl 25mg every 6 hours for the next 24-48 hours and a Medrol dosepak.
The patient received the seasonal flu shot in left arm and H1N1 shot in the right arm, ~3 inches from the tip of shoulder on 12/11/2009. He did not have any local swelling, redness, pain or tingling/numbness immediately following the vaccine. On 12/16/2009, he woke up with with severe pain in his right shoulder and twitching of the muscles in his right arm which was not focused in any particular area. He sought medical care, and was treated with steroids. Both an x-ray and MRI were negative for brachial neuritis. He is currently being tentatively diagnosed as a case of myofascitis. He is scheduled to undergo another MRI of cervical spine to rule out brachial neuritis, in a few weeks. His symptoms have lessened with treatment.
This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 673029/0616AE, expiration date not noted, dose not reported) on 16-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062, 1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006068, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 23Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 04Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 15May2022, outcome "unknown", COVID-19 (medically significant) with onset 15May2022, outcome "recovered" (19May2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (10May2022) Negative, notes: Tested negative by day 6; (11May2022) Negative, notes: Continued testing daily, negative until day 10; (12May2022) Negative, notes: Continued testing daily, negative until day 10; (13May2022) Negative, notes: Continued testing daily, negative until day 10; (14May2022) Negative, notes: Continued testing daily, negative until day 10; (15May2022) Positive, notes: but tested positive daily until day 14; (16May2022) Positive, notes: but tested positive daily until day 14; (17May2022) Positive, notes: but tested positive daily until day 14; (18May2022) Positive, notes: but tested positive daily until day 14; (19May2022) Negative, notes: Tested negative again on day 15; (unspecified date) Positive, notes: upon first positive home test. Therapeutic measures were taken as a result of covid-19. Clinical course : Other medication in 2weeks was reported as No, Other medical history was reported as None. Known allergies was reported as no.Anti viral details: product COVID 19 Treatment, Brand Paxlovid, Treatment start date 05May2022, treatment stop date 09May2022, Indication Treatment of COVID-19. Adverse event: Mild symptoms in original cycle slight wet cough, no fever, fatigue. Started Paxlovid on day 2 of symptoms, upon first positive home test. Isolated throughout. Felt symptom-free by day 5, last day of Paxlovid. Tested negative by day 6. Continued testing daily, negative until day 10. Tested positive again on day 11. No symptoms but tested positive daily until day 14. Tested negative again on day 15. No symptoms or testing since. Adverse event start date: 15May2022 Adverse event stop date: 19May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
headache, cough, nonproductive cough, low grade fever, , chills, body aches, sinus congestion, nasal congestion, sneezing. starting 11/30/21
10/22 1-hour post injection, forearm of opposite arm of injection site formed an itchy rash.  Took 2 Benedryl per nurse's instructions. 10/23 Next morning (7 am), rash area swelled and started to spread up the elbow.  Rash also appeared on collarbone. Wave of fatigue & fever hit at lunchtime.  100.6 degrees Temp was 99.6 at Dr. office at 2:30 pm. Temp back up to 100.2 at 10 pm. 10/24 Temp still at 100.2 at 5 am and at 1 pm.  Still have temp. Rash flare up on right forearm & spread up to neck.
A female patient (age not reported) experienced a "metallic taste in mouth" within 24 hours after receiving Fluzone (lot number U2242AA, date, route and site of administration not reported). It was unknown if the patient recovered. This case has the same reporter as case 2006-02857.
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a five-year-old male. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 04-Dec-2011. On 07-Dec-2011, the patient received expired product. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was obtained on 06-Apr-2012: the reporter stated that the patient did not experience any late occurring adverse events.
Lymphadenopathy of right supraclavicular node for the last 3 weeks and counting
Pt recvd Hep B vax JUL91 & exp burning & pain @ inject site; lot# of Hep B vax was changed & the sx did not recur;
Vial was initially stored in the refrigerator on 30-Jun-2022 and dose was administered on 05-Aug-2022; No Adverse reaction; Used Moderna Covid-19 vaccine last week beyond its use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Used Moderna Covid-19 vaccine last week beyond its use by date.), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-Jun-2022 and dose was administered on 05-Aug-2022) and NO ADVERSE EVENT (No Adverse reaction) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Used Moderna Covid-19 vaccine last week beyond its use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-Jun-2022 and dose was administered on 05-Aug-2022) and NO ADVERSE EVENT (No Adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Used Moderna Covid-19 vaccine last week beyond its use by date.), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-Jun-2022 and dose was administered on 05-Aug-2022) and NO ADVERSE EVENT (No Adverse reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse reaction) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Used Moderna Covid-19 vaccine last week beyond its use by date.) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-Jun-2022 and dose was administered on 05-Aug-2022).    No concomitant medications were reported. Patient received second booster. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine was reported as unknown. Vial was initially stored in the refrigerator on 30-Jun-2022.Vial did not undergo any temperature excursions. Patient seeked medical care reported as unknown. No treatment information was provided.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 18-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vails were frozen  when  received and was immediately placed in the clinic vaccine freezer. The vials remained frozen until the date of use and were thawed in the vaccine refrigerator prior to use. Only 1 vial was used per day between the hours of 8:00am to 4:00pm. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Vomit; chills; fever; body ache; exhaustion; headaches; This is a spontaneous report from a contactable consumer (patient). A 37-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6208, Expiry date: not reported), via an unspecified route of administration on 11Mar2021 (at the age of 37-years) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included Melatonin, Polycarbophil calcium (FIBER), Multi vitamin and Hyde pre workout. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6203, Expiry date: not reported), via an unspecified route of administration on 18Feb2021 15:00 (at age of 36-years-old) as dose 1, single for covid-19 immunisation. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and post the vaccination, the patient was not tested for COVID-19. On 12Mar2021 at 12:00, the patient experienced vomit, chills, fever, body ache, exhaustion and headaches. Treatment for the adverse events was Theraflu. The outcome of all the events was reported as not recovered.   No follow-up attempts were possible. No further information was expected.
6-8 hrs post injection fever > 103, body aches. Resolved within hours. No source found
Developed shingles left C2, 3, 4 dermatomes. VALTREX, MEDROL Dose Pak.
Trouble breathingbut not enough to rush to the hospital. Her 02 didn't go below 93 percent; She had stomach problems and pain in stomach, and an over all feeling of being sick; Exhaustion; over all feeling of sick; headache; This is a spontaneous report from a contactable consumer (Patient). A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in left arm on Monday 05May2021 (at the age of 68-year-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history included ongoing rheumatoid arthritis Diagnosed 16 years ago, ongoing systemic lupus erythematosus Diagnosed 15 years ago, influenza immunisation from an unknown date and unknown if ongoing. She stated she gets the flu shot every year she was fine. She was taking Remicade IV infusion at the hospital but had to stop because she had an allergic reaction to it. This was a few months ago. The patient concomitant medication(s) included ongoing methotrexate, ongoing prednisone and ongoing hydrochlorothiazide from unknown date. No other additional vaccines administered on same Date of the Pfizer suspect; no prior vaccinations received (within 4 weeks). She received at hospital and therefore, does not have a lot/exp. Historical Vaccine include bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0169), via an unspecified route of administration, administered in left arm on Monday 15Apr2021 at 12:15pm (at the age of 68-year-old) as DOSE 1, SINGLE for COVID-19 immunization. She states she went and had second shot Wednesday 05May2021 at noon and by midnight she was very very sick. On 06May2021 at 01:00am in the morning symptoms started, she was having trouble breathing, but not enough to rush to the hospital. Her 02 didn't go below 93 percent. She had stomach problems and pain in stomach, and an overall feeling of being sick. This went on 4 days. On the 3rd day she didn't have trouble breathing but her stomach and headache were still ongoing. She first thought maybe had some kind of sickness before she got the shot and it just appeared. Adverse Events does not require a visit to Emergency Room and Physician Office. Outcome of the event trouble breathing was recovered on 07May2021, while for all other events it was recovering.   No follow-up attempts are needed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021527283 same reporter/drug/event, different patient
9 Days after first injection, developed a 2 inch  red circular, raised feverish lesion. site is itchy and feels like cellulitis.   PT. took, benydryl and topical hyrdrocordzion cream. site has not cleared up, and it has been 36 hours since patient first noticed rednesd
Tuesday April 20th I woke with an massive headache (rarely get headaches).  Wednesday April 21st, very tired and muscle aches.  Wednesday night 101 fever started for 24 hrs.  Tired, headache, body aches continued until 4/28/2021.  I had 2 negative COVID tests and 1 negative flu test.  Always masked outdoors, alcohol wipes and hand washing so it is unlikely I picked up a virus.    I cancelled my 2nd dose that was scheduled for 4/27 (Dr recommendation due to symptoms)  I am very concerned about getting the 2nd dose as I suspect this illness was due to the vaccine since there are no other explanations.
10 days after receiving vaccine pt had rash on both upper arms and upper inner thighs. The rash was oval shaped fluid filled was slightly itchy. Pt used "brown laundry soap" and rash mostly resolved after 4-5 days.
Fever, tonsil infection, cough, hearing problem, ear infection, eye infection. Tylenol was given to reduce fever.
vomiting; lightheaded; Dizziness; pain; blurred vision; headache; This is a spontaneous report from a contactable consumer. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration on 22Jul2021 at 03:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. On an unknown date in Jul2021 the patient experienced vomiting, lightheaded, dizziness, pain, blurred vision and headache. Therapeutic measures were taken as a result of the events which included first aid and vitals. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events vomiting, lightheaded, dizziness, pain, blurred vision and headache were 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.
Mild headache prior to receiving the Vaccine but the head pain has increased to severe in the hours and day afterwards. All other symptoms (body aches, sore arm etc) are minor Patient has taken 500 mg Tylenol the afternoon of the vaccine and 1000 mg the day afterwards with little affect.
Has swelling and redness (R) thigh - MMR-Varicella site. Rx - Prednisone 18mg daily x 5 days. Cephalexin 200mg bid x 10 days.
Information had been received on 26-MAY-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 22-MAY-2015 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 02-JUN-2015, the female patient was treated at a health facility for a vesicular outbreak that was diagnosed as severe shingles. On or about 27-AUG-2015, the female patient reported her reaction and illness caused by ZOSTAVAX to the VAERS database. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages.  Additional information has been requested.
pt received pfizer at outside location.  Reports day after receiving vaccine had rash for 5 days.  Rash:  bright red indurated splotches.  Located on buttocks, truck thighs, arm. Pruritic and tender.  Resolved 5 days later, except for erythematous patch on left medial thigh.
Mother stated that patient developed a fever about 10 days after receiving vaccinatons injections and the fever spiked and the patient had 1 seizure while setting the table for dinner. Mother stated that she took patient to local hospital ER and patient was given Ibuprofen and Tylenol for fever and observed and released. Blood work done during ER visit showed elevated WBC and physician suggested patient had a viral infection. Mother stated that patient did not have any more seizures after first one and his temperature decreased as well.
Red, warm to touch, about 2x3 inch area of arm where the shot was given within 2 days of administration. Prescribed cephalexin. Diagnosis cellulitis.
I started getting fluid around my ankles and on the sides of my feet the day after my first dose of Pfizer COVID-19 on 11/27/2021. Then about two days later I started having fluid in my abdomen it seemed to be more on the right side than the left , but  was on both sides it just seemed like more swelling from it in the right. I also around this time began having pressure deep at my chest bone in the middle of my chest. My heart didn?t hurt only my chest in the middle deep inside my chest near the bone. It has been almost 3 months. The fluid around my abdomen has left I believe and the chest pain has subsided, but the fluid abs swelling at my feet and ankles has not went away. They are still swollen with fluid the same as they have been ever since the day after I received my first dose. I waited 5 weeks to take the second dose I had to have it for work. I had no wires symptoms or new symptoms with the second dose, but like I said the swelling from the first dose hasn?t left. I  do NOT have  any health problems. I do NOT have high blood pressure and I?ve NEVER had swollen ankles or fluid ever in my life except when I was pregnant 15 years ago. I do not have health insurance and couldn?t find any help to afford any tests, but I think by what I?ve read and  I have been dealing with mild pericarditis caused from the vaccine. I would love to get help to get rid of the fluid on my feet.
pt recvd flu vax 10NOV93 & immed following vax pt exp pain & limited motion in arm in arm inject was given;
Pt had the varicella vaccine on 10/24/95. Pt was dx'd with chickenpox on 12/5/01. Possible immunization failure.
SKin eruptions on face & chest 2 hrs p/vax recvd; pt given DPH & sx subsided w/in 24 hrs;
Onset of shingles on arm where vaccine was given. Numbness in arm and hand.
Pneumonia; Initial information received on 22-Feb-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who had pneumonia while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In 1980, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization.  In 1980 the patient developed a serious event pneumonia (unknown latency) following the administration of Influenza Vaccine.   It was reported that got a flu shot in 1980, forced by the military, and three days later had pneumonia what's the connection, I don't know, but I won't take a flu shat again.  Action taken : Not applicable.  Corrective treatment : No corrective treatment reported for the event.  Event outcome : Unknown for the event.  Seriousness criteria : This event(pneumonia) was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 28-Feb-2022:This case involves an unknown age and unknown gender patient who had pneumonia while receiving vaccine Influenza Vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses, and concomitant medications. The role of the vaccine cannot be assessed this.
At 10:28 the patient c/o dizziness and SOB o2 99% HR 74, patient mentioned it happened with her previous vaccines and only had coffee in am. At 10:36 temp 97.8 o2 99% HR 72 R 16 B/P 120/80. At 10:45 O2 99% HR 67 B/P 120/80 R16. At 11:00 O2 99% HR 65 B/P 120/80 R 16. Patient mentioned she was feeling better and was cleared to go home. She was educated to hydrate and get something to eat. She was D/C at 11:03.
Tues vaccine. Symptoms Tues pm 8:00pm. Stiff neck, nausea, vomit, fever 101. Thurs vomit, fever 101.
Edema/ erythema right upper arm. Treated with Benadryl PO cool compress. Resolved by 8/24