chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The side effects I experienced after Dose #1 of the SHINGRIX vaccine (administered July 2018 at same pharmacy) were the same after Dose #2 -- but the severity of all of the symptoms was more than double in Dose #2 and have lasted 5 days this time. After Dose #1, I had 1 really bad day of body aches, muscle pain, exhaustion and severe pain/inflammation/rash at the injection site. By the second day, these symptoms began to significantly diminish. For Dose #2, the symptoms have been MUCH more severe in nature and the duration has been extremely long. I was forced to bed rest for 2 1/2 days immediately after the injection and had such severe exhaustion/body pain that I couldn't leave the house. I looked up allergic reaction info on SHINGRIX.com and my symptoms appeared to be very magnified side effects rather than allergy. I notified GSK via email on Monday afternoon (02/04/2019) when I began to experience severe pain in my joints/ligaments -- particularly in an old foot fracture/torn ligaments from an accident in 2015. (The joint/ligament pain was similar to what I experienced with Tavanic allergy, so I was worried my body was reacting to SHINGRIX same way)  This joint pain prevented me from walking even to the restroom, but went away the next day. The severe and debilitating (Level 3 muscle pain and weakness, per the standard measurements I found when I googled SHINGRIX reaction) lasted until 02/06/2019. The injection area developed a large circular rashlike area that was raised and extremely hot and painful to the touch. It remains at a Level 3 pain and has prevented me from doing basic tasks since I got the shot. I used arnica gel and anti-itch gel on the area for temporary relief, but no amount of Voltafast 50mg powder or Excedrin extra strength tablets relieved the severe pain I continue to experience from the injection site. The rash is fading from the hot, bright red to a more muted red, but is still throbbing painful, Level 3.
delayed reaction to the vaccine that spread to her neck and face; A spontaneous report was received from a nurse concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event delayed reaction to the vaccine that spread to her neck and face/vaccination complication.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown)  for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event delayed reaction to the vaccine that spread to her neck and face.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event delayed reaction to the vaccine that spread to her neck and face was unknown.
Fever,    irregular  heart beat,   severe  headache,   dizziness,   strong  muscle  aches, gi  problems,  extreme   fatigue,
An expired dose of Pentacel was given to a patient, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Global Medical Information (GMI) (Reference number- 00611112) and transmitted to Sanofi on 21-May-2021.  This case involves a 6 months old male patient who was administered 0.5 ml second dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ259AAA, expiry date: 14-May-2021, powder vial- Lot: UJ259AA and liquid vial-lot: UJ331AA, expiry date: 14-May-2021) once via intramuscular route in the left vastus lateralis for prophylactic vaccination on 20-May-2021 (Expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE 13V, HEPATITIS B VACCINE and ROTAVIRUS VACCINE for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used (latency same day)  The reporter stated that yesterday (20-May-2021) an expired Pentacel was given to a patient and wanted to know what needs to be done now. The reporter asked whether another dose can be given to the patient. The Pentacel had expired 1 week ago. It was reported that they will call the patient's parents  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
PATIENT PRESENTED WITH MOTHER FOR SECOND DOSE OF COVID VACCINE,  VACCINE WAS ADMINISTERED AND WHEN RN WENT TO PUT INFORMATION INTO database NOTICED THERE WAS NO INVENTORY AVAILABLE FOR THIS.    VACCINE HAD EXPIRED ON 10/4/2022
Redness, swelling, itching, general malaise, shakiness.  Given Benadryl & ice packs to area. Red area 20cm x 16cm, warm to touch.
severe pain in arm, muscle spasms in body, lost taste, smell, weak, brain fog, balance issues, fever, sore throat, coughing, respitory issues,
p/ pt recv vax 14 days later exp 4 papules described as early vesicles.
Patient presented to emergency department on 9/2/2021 with right knee pain. He was tested for COVID-19 at admission and test was negative. During workup he was found to have infiltrates on chest xray suspicious of pneumonia and nasal swab came back positive for MSSA. Patient was found to be COVID-19 positive during screening for potential facility placement at discharge. He was not treated for COVID-19 infection during admission. He was discharged home on 9/13/2021.
Sore arm, low grade fever, fatigue  (parent not sure which arm was sore)
Headache, Myalgia, Arthralgia, Chills, extreme fatigue, LMP 1/5/2021 woke up to heavy bleeding and clots 1/12/2021 She reports that she received her 2nd dose of the Covid -19 vaccine on 1/8/2021 @ 3:00PM. She states that she developed chills and fatigue by 9PM that evening. She states that she developed nausea and muscle aches on Saturday. She states that she suffered from a "bad headache" on Sunday and successfully treated it with Excedrin. She stated that her LMP was 1/5/2021 (she is 46 years old). She states that she woke up this morning to a very heavy flow with clots which is very unusual for her. She states that she is feeling better but is still having symptoms.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EL3249), in right arm, on 03Mar2021 as dose 2, single (Lot number: EM9810), in right arm and on 25Sep2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 74 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03May2022 as dose 4 (booster), single (Lot number: 066K21A), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received covid treatment from 20Jun2022 to 26Jun2022.
Poison Ivy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12May2021 09:00 (Lot number: EW1164) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DERMATITIS CONTACT (non-serious) with onset 29May2021, outcome "recovered" (06Jun2021), described as "Poison Ivy".   Additional information: Patient had no side effects from his 2nd dose until 5 days after the dose. He woke up Sunday morning (06Jun) with his torso covered in hives. He have never had hives before and they were very itching. He had a bad case of poison ivy when he got the 2nd dose so thought his immune system may have been over stimulated. The next day the hives were from the bottom of his feet to the top of his hand. He went to the urgent care and they gave him a steroid injection and taper pack that helped but 1 week after the steroids were done. He still had hives between his fingers and toes. He took another taper pack, they mostly went away. Then another week later patient went swimming and the something in the pool must have aggrevated his skin and he got hives again. Patient was taking loratidine and famotidine in double dose for the past 5 weeks. 2 weeks into that regimine the hives went away.  No follow-up attempts are possible. No further information is expected.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 24-year-old male. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reported/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
Breast pain followed by palpable breast lump Had to do biopsy to r/o malignancy never had this before  Bloody diarrhea after 1st and 2nd dose had to do endoscopy and colonoscopy to r/o parhology
This case was reported by a lawyer and described the occurrence of joint pain in a female subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). On an unspecified date after vaccination with LYMERIX, the subject experienced joint pain and swelling, tingling in extremities, headaches, flu-like symptoms, possible memory loss, decreased activities of daily life, and rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 12 January 2009 via medical records. The subject received the first and second dose of LYMERIX both in 1998. A few months after vaccination with LYMERIX, she developed left hip pain, knee pain and swelling, and right hand pain and swelling. She also indicated that she experienced hip and back pain, and she was reportedly advised that she might have rheumatoid arthritis. Treatment included VIOXX and CELEBREX. The events were unresolved at the time of this report. The event of possible rheumatoid arthritis was assessed by GSK to be medically significant.
I was coincidentally exposed to covid prior to the Covid vaccine so I don't think the symptoms were a result from the vaccine. 12/21/2020  I received the vaccine in the AM I started to have a low grade fever, body ache, malayse, next morning I woke up and had a higher degree fever body ache and increasing feeling of sickness. I got worse and contacted my own Dr and he let me know that I may have been exposed and I got tested and I was positive for Covid. I
Initial and follow-up formation has been received from a physician concerning a 35 year old female patient with allergies (unspecified), but no known drug reactions/allergies, who on 18-JUL-2008 was vaccinated with a 0.5 mL first dose of PNEUMOVAX (lot # not provided).  Concomitant therapy included montelukast sodium (MSD), ALLEGRA-D, NASONEX.  Subsequently the patient developed an injection site reaction following vaccination described as a "welt the size of a softball that was really hot."  The patient also developed a fever of 104.0 degrees "for the past 36 hours."  The physician prescribed a topical steroid and BENADRYL.  The physician also reported that "the patient had a similar reaction to the TB test."  At the time of reporting, the patient was recovering.  The patient sought unspecified medical attention.  Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In November 2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 06-NOV-2015, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The patient was prescribed valacyclovir and gabapentin for management of her painful symptoms and chronic pain. The outcome of the events is unknown. 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.
My left shoulder felt like I had been stabbed.  I had the worst pain in my life. I took extra pain meds that I had for my back pain, but it did not help.  That day the weather was bad with snow drifts and bad roads, so I did not want to leave my house.  Same on Sunday and the pain was worse.  After contacting my doctors office I went in to see Dr. I told her that the Med student gave me the shot way to high (I had searched the internet that weekend for proper injection sites).  I rolled up my left sleeve when he was ready to give the pneumonia shot and he said "No, you'll have to take off your shirt because I need to give the shot higher". He gave the shot at a 45-90 deg angle on the crown of the shoulder.  Now I suspect he went through the Subdeltoid Bursa muscle.   By Monday morning 01/27/2014, I could not physical lift my left arm without extreme pain.  Now, 02/28/2014 I can lift my arm, but it's very painful.  I have alot of trouble sleeping because I can't find a good position to lay without a lot of pain.
The same day of the vax, the pt developed swelling from his shoulder to his elbow. As of 7/14/00, no further information was available.
Information has been received from a 42 year old male physician who "recently" was vaccinated "intramuscularly instead of subcutaneously" with a 0.65 mL dose of Zostavax. Subsequently the physician developed a knot on his arm as a result. Subsequently, the physician recovered. There was no product quality complaint. Additional information has been requested.
This case was reported by a physician via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On 9th February 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm and erythema of extremities. On an unknown date, the outcome of the pain in arm and erythema of extremities were not recovered/not resolved. It was unknown if the reporter considered the pain in arm and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of SHINGRIX in left arm. The reporter stated that the patient came into the healthcare professional's (HCP) office on 12th February 2019 with redness and tenderness in left arm. The patient required to visit emergency room (ER).
Patient received Pfizer COVID vaccine- lot number and dose number not documented.   Reaction: Angioedema, Rash, Stevens Johnson Syndrome Severity: High
Sore muscles through 3/30.  Severe joint pain continuing.  Knees have been replaced and they hurt like they did 2 wks after surgery.  Right shoulder had cortisone shot 2/24/21 and it hurts more than it did before that. fingers hurt to bend,  It is now 1 week since the injection
7.5 x 8.5 area of pinkness at area of shot. No fever, drainage or pain.
States noted a pain in her shoulders within a couple of days after vax. States it was an achy joint kind of pain and symptoms lasted 1 month total. Pain moved to various joints in head to toe sequence; first shoulders, then elbows, wrists, fingers, hips, and knees.
Sick flu-like symptoms X 10 days (began on skin with fine rash off and on with hot, itchy skin X 10 day and some nausea and vomiting). History of having just started a new Estrogen replacement on 12/1/00. Referred to PMD for evaluation with regards to new HRT.
Pain at injection site; mild headache, body aches, nausea, (flu like symptoms). 400mg ibuprofen twice 6 hours apart. Symptoms last 24 hours
Body ache; Headache; Fatigue; Two doses; A spontaneous report  was received from a consumer concerning a male patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced body ache, headache, fatigue and administered two doses of vaccine.  The patient's medical history was not provided. No concomitant medications were reported.  On 27 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch number: 09L20A), for prophylaxis of COVID-19 infection.  On the same day, the patient was administered two doses of COVID-19 vaccine.  On 28 Jan 2021, the patient experienced body aches, headache and fatigue after received the COVID-19 vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, body aches, headache and fatigue was not reported and that of extra dose administered was considered as recovered on 27 Jan 2021.; Reporter's Comments: This case concerns a male patient, who experienced an event of extra dose administered and  non-serious expected events of Pain (body ache) , headache, fatigue . There were no AEs associated with event of extra dose administered (two  doses on the same day).The events of Pain (body ache), headache, fatigue occurred 2 days  after two doses of mRNA-1273, lot # 025L20A administered on the same day.  Based on the current available information and temporal association between the use of the product and onset of the events ,  a causal relationship cannot be excluded.
I had body aches without fever, a headache, lethargy, mild chest tightness, and a sore throat. I went to an urgent care facility to get a covid test. They did 2 tests, and they both came back negative.
Mild, extensive, pox - like papules on the trunk and extremities with no constitutional  symptoms  except mild pruritus.
I reach out to a nurse practitioner/friend to look at my arm, due to cellulitis, there was a rash, swelling and pain around the vaccine site. It grew about a half an inch by November 4th, 2021. I took Benadryl and it is completely back to normal with mild itching and a slight red color.
received his first Pfizer Covid 19 Vaccine on 10March2021. The patient tested positive for Covid on 23March2021.; received his first Pfizer Covid 19 Vaccine on 10March2021. The patient tested positive for Covid on 23March2021.; This is a spontaneous report from a contactable Pharmacist. A 66-year-old male received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) via unspecified route of administration on 10Mar2021, as 1st dose single, for Covid-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient tested positive for Covid on 23March2021. While in the hospital he received the monoclonal antibodies. He was advised by the MD that he would need to start the vaccination series over. Caller asked if the information is correct for restarting the vaccination. The patient underwent lab test which included Covid test as positive on 23Mar2021. The outcome of the events was unknown.   Information about batch/lot number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the Lack of efficacy, COVID-19 and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)
Headache, sore at injection site, nausea, all over fatigue, muscle fatigue
It was reported that an 85 year old female pt, post vax, reportedly on 9/25/1998, experienced generalized urticaria.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 06-APR-2015 the patient received an expired dose of ZOSTAVAX (lot # K000328, expiration date 06-MAR-2015, 0.65 ml, subcutaneously). No adverse experiences reported. Additional information has been requested.
Lichens sclerosis; This spontaneous case was reported by a patient and describes the occurrence of LICHEN SCLEROSUS (Lichens sclerosis) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had never been diagnosed or tested positive for COVID-19.  Previously administered products included for Product used for unknown indication: Flu vaccine (in fall) in 2020 and Flu vaccine (in fall) in 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine and Flu vaccine. Concurrent medical conditions included Sulfonamide allergy (Sulfa drugs allergy), Hypercholesterolaemia (No changes noticed after vaccination, condition present before vaccination), Arrhythmia (No changes noticed after vaccination, condition present before vaccination) and Arthritis (No changes noticed after vaccination, condition present before vaccination). Concomitant products included SIMVASTATIN for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced LICHEN SCLEROSUS (Lichens sclerosis). At the time of the report, LICHEN SCLEROSUS (Lichens sclerosis) outcome was unknown.            Concomitant medications also included Hidrcor and Clovividol.  For dose 1, the site of vaccination was provided as deltoid muscle. It was reported that the patient thought that the side effect of Lichens Sclerosis might be a side effect of the vaccine because of increased immune activity and enquired whether it was related or not. The patient was referred to a healthcare professional.  No treatment information was provided.   This case was linked to MOD-2022-657551 (Patient Link).