chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Reporting is for a vaccine administration error where an adult patient was administered the Pfizer BioTech vaccine 5-11 years formulation(orange lid), resulting in a lower than authorized dose for a booster. There is currently no adverse event. Patient was notified immediately about the error and the correct age appropriate dose of Pfizer-Biotech vaccine has been given on 12/09/2021, as per CDC and vaccine manufacturer guidelines.
This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose, refer case US2019GSK005180). On an unknown date, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, immediately after receiving SHINGRIX, the patient experienced pain in arm and general body pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm and general body pain were recovered/resolved. The reporter considered the pain in arm and general body pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. Both immunizations given at same pharmacy. Lot number was not known. Arm began to hurt immediately upon immunization of both doses. Immunized person reported never being so aware of where arm was even if the patient was not moving. With both doses, side effects lasted about 2 days. The patient thought experienced events were related to immunization. For tolerance after 2nd dose refer case US2019GSK002321. The reporter did consent to follow up.
The employee came to me stating "I don't feel right. I just got a flu shot and my chest feels heavy." I took her to the clinic for vital signs. BP 243/123, P 112, O2 Sat 97%. She denied chest pain or SOB. She took 25 mg po BENADRYL and I put her in a w/c and took her to the E.D. after she finally allowed me to take her. Her face was red and she was A + O.
aching for 1 1/2 wk, swollen wrists & knees;As of 23APR96 index cont to get pain in wrist & knees;now traveling around body to ankle & feet;
Upon entering the domicile at Correctional Facility, the patient was retrieved and asked to sit in a seat directly outside of his cell. Demographic information was verified by the lead correction officer along with the nurse Via identification band.  The nurse continued to verify if the patient had any allergies to medication, latex, and or band-aid adhesive. The client noted no allergies, at which time the nurse also verified any medication use. The nurse then asked if the patient had taken any covid vaccines Jessen, Pfizer, or modern. The client stated ?no I have not received any covid vaccines. The client was appropriately cleaned using an aseptic method and vaccinated using Moderna lot# 022c21a. The patient was then returned to his cell to be monitored for 15 minutes. The Vaccine was tolerated well with no adverse reactions. MODERNA manufacture safety report case # MOD 21-109154
Redness, swelling, itching, and shingles-like blistering at injection site.
exposed to Covid-19 between first and second vaccines, tested negative for Covid-19; he felt a little like he was coming down with something; he was not really hungry; tired; This is a spontaneous report from a Contactable consumer. This consumer is reporting for himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 28Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received the first dose of the vaccine in February and got or was exposed to COVID to someone with the COVID in-between the first and second dose. Patient stated, again, it was the first week and he had a customer he was near but they both had masks on. He was wearing an N95, and she had a medical mask on. They stayed the six feet, and he was not around her long. She told him the next day and texted him that she had it. He got tested one week later. He just had a part of one weekend where he felt a little like he was coming down with something. He was not really hungry and was tired on an unspecified date in 2021. He then tested negative. He got the second dose after testing negative. Then, he periodically got purple spots on his left arm on an unspecified date and right arm joint was tender every once in a while, on an unspecified date and he wanted to make sure or know if that was part of it. He wanted to make sure he was fully vaccinated after being exposed to the virus. A couple of weeks later, on an unspecified date he developed a few dark spots on his left arm where he got the shot. It was on his mid forearm between the forearm and the wrist, on top. And then it would go away and he would get more, it would be different, darker to lighter. It always went away; he did not have any currently at the time of report. He also had on his right arm near the elbow, occasional soreness. Patient was really thankful for the first shot since he was possibly exposed. He never really developed symptoms and he was testing himself regularly like his temperature. Patient reported that his first vaccine was 28Feb2021 and then three weeks later was the second, but he does not have his card. Patient did not really want to report anything other than that he did not experienced anything. The patient underwent lab tests and procedures which included Covid-19 test: negative on an unspecified date in Mar2021. Outcome of all the events was reported as Unknown at this time of the report.   Information upon lot number/batch number has been requested.
Pt reports no significant reaction or problem until about 3 days ago when he began experiencing difficulty raising left arm above head. Denies swelling, heat, tenderness to touch or fever.
Mar. 1, Day of injection- sore arm, fever up to 100.8; significant chills; Mar 2, Day after injection, arm very sore, fatigue, highest fever 101.8;  Mar. 3, fatigue, tongue & mouth started to tingle, rash on trunk of body & arms; highest temperature, 99.8; Mar. 4, fatigue tongue & mouth tingling more pronounced, Mar. 5, Fatigue, tingling in tongue, mouth & lips
Pain radiating to elbow, significant swelling with softball sized lump. Arm is hot and pulsating. Fever. Wheezing. Spoke with doctor and being prescribed Keflex and prednisone. I had a similar reaction to the first shot.
In late May or early June, I started developing a cluster of symptoms that began with anorexia and weight loss and progressed over several weeks to include insomnia, tremulousness, arrhythmia and palpitations. I sought medical attention and was diagnosed with toxic multi-nodular goiter. Conservative treatment was started with atenolol and low-dose methimazole. This week, after three months of treatment, repeat labs now reveal hypothyroidism. Atenolol is being weaned and methimazole has been discontinued. Labs will be repeated in four weeks, at which time it is anticipated that methimazole will be restarted with a different regimen. Atenolol will not be restarted as numerous side effects occurred with its use.
This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Contracted psoriasis) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Contracted psoriasis). At the time of the report, PSORIASIS (Contracted psoriasis) was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medications were reported. The patient had Humira given as a solution for injection in pre-filled pen. The reporter did not have the lot number information, because the packaging was discarded. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter causality for an event of contracted psoriasis with adalimumab (Humira) was a reasonable possibility. No treatment medications were reported.
Narrative:  COVID infection following COVID vaccine series 04/22, Pfizer, dose #1 05/13, Pfizer, dose #2 09/15 pt cc: chills, cough, diarrhea, fatigue, headache, loss of taste or smell, myalgias, dyspnea, vomiting, exposure: unknown 09/16 ABG: i-pH 7.19, i-PCO2 26.1, i-P02 54, i-HCO3 9.9, 09/16 i-creatinine 1.3 09/16 i-BUN 37 09/16 i-glucose 648 09/16 i-chloride 94 09/16 i-anion gap 29 09/16 i-TCO2 10 09/18 i-Hemoglobin 18.4 09/16 i-Hematocrit 54 09/16 i-Sodium 127 09/16 i-Potassium 5.4 09/16 BinaxNOW COVID-19 Ag: deteted 09/16 SARS-COV-2 Variant Sequencing result: pending 09/16 COVID swab, result: detected 09/16 CXR impression: Extensive reticulonodular opacities within the mid and lower lung zones bilaterally, RIGHT slightly worse than LEFT, could reflect ongoing bronchiolitis among other etiologies. This might represent the inciting illness for the reported diabetic ketoacidosis. No focal pneumonia or pleural effusion. 09/16 pt admit ED cc: n/v dx: Acute COVID-19 infection complicated with pneumonitis/PNA with mild hypoxemia LOS: 2 days 09/16 lactic acid 2.76 09/17 FIBRINOGEN: 365 09/17 DDIMER: 1.26 09/17 ESR: 27 09/18 DDIMER: 1.55 09/27 clinically resolved
Hives and itchiness-starting 8 days after booster.  Took Benadryl and was prescribed a Medrol Pak. Symptoms have continuously improved, however, they are not 100% gone yet.
Patient presented to the ED and was subsequently hospitalized with pneumonia due to COVID-19. He has been currently hospitalized since 4/7/21.
Post flu vaccines had diarrhea with trip to ER for dehydration and higher fever. 9 days diarrhea starting w/in 1 day of 1st influenza vaccine.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 07-OCT-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: K026666, expiry date: 22-OCT-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Four hours after vaccination her site was sore; six hours after vaccination it was difficult to move her arm; she couldn't get comfortable and it has been painful - can't sleep well; the area is swollen and she has trouble lifting her arm; She went to her PCP today and was referred to an orthopedic physician for treatment of possible SIRVA;
Patient felt light headed and fainted after receiving the Janssen Covid Vaccination.  Patient fell but did not require medical attention and refused medical attention when asked.
pain in the arm after the shot. He got it with first shot too; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Feb2021 (Batch/Lot number: unknown) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Patient History: No. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "pain in the arm after the shot. He got it with first shot too". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Both he and wife at 72 and 73, take no medications. They just take vitamins.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Around 1 hour after receiving the vaccine, the area of the arm that the vaccine was given in began to swell, turn red and become warm and painful. Patient went to see physician the next morning. Doctor was unsure of cause and prescribed prednisone and cephalexin in case it was cellulitis.
This was my 3rd Moderna, the  booster shot. I reacted badly to the second shot and I am having a tough time with this one too! On administration, Flushing, fatigue, dizzy, confused. Sore arm, severe chills, high fever (104), muscle aches, weak, dizzy, shortness of breath, wheezing, asthma, cold sweats , headache, stomach cramps, Injection site swelling , burning, redness, itchy., severely swollen axillary and arm lymph nodes,  weakness, loss of appetite, insomnia.
4/14/21 ist dose, 2nd dose5/5/2021.  9/9/2021 admitted, symptoms started 9/5/2021 chills, abd pain, vomiting, fever 101, denies diarrhea, cough. went to ER prescribed zofran 9/7 fever cont, sever abd pain, HA, nausea, and constipated. (RSV, flu,strep and covid all negative. home mom Miralax. 9/8 frequent diarrhea, abd pain, vomiting.  elevated troponin, CRP, IL-6 ferritin, myocarditis.  suspected MIS-C. negative,  Sars coV-2 PCR negative, Igg & Igm antibody positive 9/9. eats hot dogs at work. coworker had covid 3 weeks prior. Pt works in family chicken coop and consumes fresh eggs.  blood cx positive gram negative sepsis by Salmonella. discharge dx Sepsis by Salmonella with organ dysfunction. No reaction or events at time of vaccination ist dosse 4/14/2021 second dose 5/5/2021.  With symptoms, possible exposure and elevated inflammatory markers case was initially suspected to be MIS-C; but found to have alternative diagnosis sepsis by Salmonella with organ dysfunction. (so not reported as MIS-C)   Vaccine history noted during MIS-C investigation(2nd dose 4 months before onset).  Was told to report to VAERS. Information pulled from medical record during MIS-C investigation.
Pt was seeing things on the wall and trying to pick something off the wall. Pt also experienced stomach ache.
Immediate arm sore, red mark, skin rashing about elbow of same arm, lump size of golf ball appeared under left arm pit.  Not even two weeks later, nausea and vomiting, diarrhea, sharp stabbing pain in upper stomach and chest wall, chest inflammation, bruising all over legs, fatigue, overall pain, vision problems, weakness, high blood pressure, all within two weeks of getting shot.
diphenhydramine 50mg given at 12:20 PO, epinepherine injection at 12:22 IM, ambulance arrived at 12:35 for transport to local hospital.
Joint and body aches, chills, tiredness, redness and swelling at injection site Responded partially to ibuprofen during 1st 36 hours.  Symptoms still present at 48 hours but improved.
that they used a distilled water instead of solution.; Firmness in my arm; This is a spontaneous report from a contactable consumer (patient). A 64-years-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: ER8732, expiration date: unknown, they told him 2 weeks, but there was no Expiration dates on the sticker that they put on the card, vaccination card), via an unspecified route of administration, administered in Arm Left on 27Mar2021 (at the age of 64 years) as dose 2, single for covid-19 immunisation and water for injection (distilled water [water for injection), via an unspecified route of administration from 27Mar2021 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for an unspecified indication. Historical Vaccine included first dose of BNT162B2 (LOT number: EN6198) in left arm on 06Mar2021 for covid-19 immunisation. Medical history included back pain, Congestive heart failure, allergy and cholesterol. Concomitant medications included Atorvastatin for blood cholesterol, Baby Aspirin, Alerid for Allergy and Moxicip. On 07Apr2021, the patient stated that vaccination centre used a distilled water instead of solution and had firmness in his arm. Patient stated that the centre called him that they used a distilled water instead of solution. They want him to come back and have a third shot because they said they need to develop the amount of vaccine that they had given. Patient stated a few symptoms, but nothing serious. Had firmness in his arm when they gave him the shots and he thought that was because they injected that too fast and loaded in the muscle and that happens with both shots. So, and that went after one day. The patient underwent lab tests and procedures which included blood cholesterol which was unknown results. At the time of report, outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Large skin abscess on right buttock. Drained on its own within 36 hours. Doctor prescribed antibiotic. Normal pregnancy. Estimated date of delivery is 7/29/2021.
Breakthrough case admission after 4 vaccines Moderna 3/16/21 Lot# 040A21A;  Moderna 4/13/21 Lot# 037A21B;  Moderna 10/26/21 Lot# 039D21A;  Moderna 6/22/22 Lot# 059M21A;
infrequent/intermitted development of  ring shaped bruises near armpit, forearm, legs and penis. Not painful but visible.
The second day I had a fever of 102.  I felt fatigued and had achy muscles.  This was gone by the evening, around bedtime. about 1 1/2 weeks later,  I found spots on my arms, spread out on both, maybe 5-6.  They were wide and looked flat and red, and were itchy.  The appearance was sort of like a blister, but not full of pus or open.   These continued on and off, and after one month, most were gone.  The dermatologist prescribed an anti itch cream, yet it did not do anything to clear up the spot.  A few days ago, I found a couple more new spots, like the previous ones. but they were not as pronounced, yet they still itch, also one on my leg. One is healing and the appearance in like a round spot drying up, inside a red larger spot, as it is healing or subsiding.
Blood pressure increase, racing heart (while at rest), hives starting at 11:30 am (approx 40 min post injection)
Chills and low grade fever lasted from about 2pm on 4/19/21 to about 1am on 4/20/21.  Body aches and fatigue started about 5pm on 4/19/21 to about 1am on 4/20/21.
Narrative: Patient reported that the evening after his 4th covid shot (2nd booster) he fell in his bathroom after "passing out" . Initial report was that he fell prior to going to the bathroom, but during the er report it was found he fell after standing up after using the toilet and becoming lightheaded, did not report losing consciousness there. He fell on his knee that had a previous replacement done and had residual pain there. ER found no acute issues and patient was  discharged home with no interventions noted.
pt stated after getting vax she had 3 days of tenderness on the left arm.  Ten days later she developed a large red rash w/ hives from her injection site down the entire left arm.  The injection site is has a knot the size of a golf ball.  Pt  saw PCP and was told to take Zyrtec and to keep an eye on it.  After taking Zyrtec for 2 days her symptoms were better.
Rash at injection site within 24 hrs, cheeks within 48 hours, and entire body within 96 hours
pt recvd vax & inj site sore x 3 days; 9 dyas after vax pt devel red raised rash on L upper arm; progressed to blisters which spread; tx w/ augmentin by MD;
COVID-19; COVID-19; Pfizer, Dose Number: 5 / Moderna, Dose Number: 1, 2, 3, 4; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. An 83-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 15:30 as dose 5 (booster), single (Lot number: 8J5342) at the age of 82 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Jan2021 at 14:00 as dose 1, single (Lot number: 004M20A), in left arm, on 27Feb2021 at 13:00 as dose 2, single (Lot number: 023nZurt), in left arm, on 03Sep2021 at 01:00 as dose 3 (booster), single (Lot number: 048F21A), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: 002M21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Sep2022, outcome "unknown", described as "Pfizer, Dose Number: 5 / Moderna, Dose Number: 1, 2, 3, 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: testing negative on two successive days for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 24Mar2023 to 29Mar2023.  No follow-up attempts are possible. No further information is expected.
Left arm soreness 1-2 days following injection. Red itchy welt 9 days after injection. Large red lesion 10 days after injection, no longer itchy. Not painful. No treatment for symptom. Currently pregnant. Due date 07/01/2021.
died 3 weeks later after getting the vaccine.; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse  reported that a patient (unknown age and gender) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose for COVID-19 immunisation on unknown date. Relevant history and concomitant drugs were unknown. The patient died 3 weeks later after getting the vaccine.  It was unknown if autopsy was performed or not.; Sender's Comments: The causal relationship between BNT162B2 and the fatal event cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.  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.; Reported Cause(s) of Death: died 3 weeks later after getting the vaccine.
8 days after injection, pain and swelling at injection site.  Rash and itching around injection site.