chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccinations were performed through our mobile health team on site. Both Moderna and Janssen were being offered on site. Patient consented to Janssen as her first COVID vaccine on 03/31/2021. It is possible she received Moderna vaccine instead because both types of vaccine were being prepared and administered at nearby stations. Patient notified of possible error.  No side effects/adverse events as of 04/08/2021 after following up with patient via telephone.  Department of Public Health was informed and advised for patient to receive 2nd Moderna vaccine 28-42 days after initial vaccine due to our uncertainty as to which vaccine she received on 03/31/2021.
Popular rash on R deltoid began 5/4/09 and today 5/6/09 erythema and in eye itchy spread to both forearms in addition 3-5m papule have appeared in multiple areas on all limbs + groin area.
A registered nurse reported that they administered expired FLUMIST to one patient which started on 05-Feb-2013. The outcome of the event of ADMINISTRATION OF EXPIRED FLUMIST is unknown. The report was considered to be non-serious. Summary of follow-up information received 12-Mar-2013 from Health professional: Dosing regiment lot number and expiry date added for suspect drug.
Initial information received on 28-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 2 months old male patient who was vaccinated with ACT-HIB (lot number: UI803AAA, expiry date: 01-July-2018), via intramuscular route in the left thigh, on 28-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccination included DAPTACEL and Rotavirus. It was an actual medication error due to expired vaccine used. The patient had no adverse event. 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. List of documents held by sender: none.
Patient was given the Covid 19  Moderna vaccine x2 at age 14. No adverse symptoms have been reported.
Lost use of my right arm so I went to the hospital they checked for a clot I teated slightly positive with the blood test then the did an ultrasound and couldn?t find one. The only explication for my Paralysis is a mini stroke.a  Also besides the  numbness and loss of use  I have hyperreflexia.
This spontaneous report has been received from a nurse referring to a 22 year old female patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patient was vaccinated with a complete 3-doses series of RECOMBIVAX HB (strength, doses, routes, lot#, expiration dates and anatomical locations were not reported), as routine vaccination. The patient was seen in the medical office on 16-MAY-2017 and had "Hepatitis B titers drawn" (for an unspecified reason) which showed that her titers were low (hepatitis b surface antibody negative); no further clarifying information was provided. The outcome of hepatitis b surface antibody negative was unknown. The causal assessment between the event and the suspect therapy was not provided. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA013186.
Swelling at the site of injection.  Dr. diagnosed it as cellulitis.   This was reported to the pharmacy by Dr.'s office.
COVID infection; Shoulder swelling after injection (15 minutes post injection).; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE SWELLING (Shoulder swelling after injection (15 minutes post injection).) and COVID-19 (COVID infection) in a 74-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Trigeminal neuralgia, Hypertension and Congestive heart failure.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING (Shoulder swelling after injection (15 minutes post injection).). an unknown date, the patient experienced COVID-19 (COVID infection). At the time of the report, INJECTION SITE SWELLING (Shoulder swelling after injection (15 minutes post injection).) had resolved and COVID-19 (COVID infection) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.  The treatment medication was not reported by reporter.
Ongoing Headaches. I got an MRI June 8th. Done for it and it showed nothing. I never have headache. I had terrible fatigue, unusual fatigue. I went to the doctor for it. I worked on my feet 10 hours a day and I never sit down but this is whole body fatigue. Lower extremity fatigue and loss of strength. I usually run for exercise, it felt like I was running in cement. Would have to walk mostly. I told my doctor that I was so tired, it was like if I hadn't been in as good as shape, I wouldn't have been able to walk up a flight of stairs. It was terrible fatigue. My upper body didn't lose strength. Also, joint pain, knees and back of knees mostly. Brain fog, I couldn't even complete a sentence sometimes. I was spaced out and couldn't think. I complained to people about it because my head was so fogged that I couldn't speak, words wouldn't come out. They symptoms are minimal now at this point of time. I do still have some bad days now but the prior six months or so before this, it's been rough. I have had friends say pretty much the same thing, maybe not as bad as I have had but they have had the same type symptoms. As it was happening, I chalked it up to doing too much. But looking back, I think it was the vaccine. No treatment because doctor couldn't find anything. Occasionally, I took Tylenol and ibuprofen for the headaches and joint pain every now and then but it really didn't help with the headache. I don't have the headaches anymore. The joint pain comes and goes now. The fatigue is a lot better, may not be back to normal but a lot better.
102 fever, extreme fatigue, muscle aches, headache, hoarseness, cough.
FELT SICK / DID NOT FEEL GOOD; This spontaneous report received from a consumer concerned a female of unspecified age The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. Batch number was not reported has been requested No concomitant medications were reported. On 13-MAR-2021, the subject experienced felt sick / did not feel good. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt sick / did not feel good was not reported. This report was non-serious.
Five (5) minutes after receiving vaccination (21:15), patient experience redness of skin or urticaria in the entire body area. The Paramedic on-site assisted the patient immediately evaluating airway, breathing and circulation (ABC) which were never compromised. Patient blood pressure (BP) was 185/100, heart rate (HR) 80 and oxygen saturation of 96% at room air. Paramedic applied Benadryl (25mg, IM) on right deltoid muscle (opposite to vaccination site). Ten (10) minutes after Benadryl injection ABC remained stable with a BP 179/99, HR 78 and oxygen saturation of 96%. Thirty-five (35) minutes after vaccination patient remained alert, stable, and urticaria diminished visually.
Since receiving the booster, I've had significant nasal congestion in the morning. The clinical term for it is dried nasal mucus (boogers), but extraordinary in the morning. I thought it would go away but it has been over a month with no end in sight and since I work in clinical research, I figured I'd report it. I had very few symptoms after my Pfizer 1st & 2nd shots.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and fever. On an unknown date, the outcome of the influenza-like symptoms and fever were unknown. It was unknown if the reporter considered the influenza-like symptoms and fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's friend. The age at the vaccination was not reported, however the patient was in the 60s. The reporter refused to provide demographic information or any information pertaining to her two friends. The reporter stated she did not want to share information pertaining to this report. The patient had denied permission to contact their physician. This case is linked to the case US2018GSK102616, reported by the same reporter.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Information has been received from a consumer concerning her 12 month old son with no drug reactions and no allergies and with phenylketonuria who on 30Jun05 was vaccinated with a 0.5mL dose of varicella virus vaccine live. There was no concomitant medication. On 01Jul05 the pt experienced elevated blood levels. Unspecified medical attention was sought. The outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested.
Immediately after vaccination pt had a vasovagal episodes and lost consciousness for less than 10 seconds, he recovered and after 10-15 mins left the office. Later that evening, about 3 hours after vaccination pt reported loss of appetite, nausea and not feeling well. No fever. His dad woke checked on him a few times in the night and he remained alert, but early in the night he still felt unwell, dad reported he was clammy but never had any shortness of breath or further symptoms. By morning he had returned to his usual state of good health.
Patient is fully vaccinated and boosted 8/18/2021. COVID + 1/23/2022 on admission to hospital. 84-year-old male who presented with fatigue and generalized weakness. Patient also had poor appetite and cough. Positive for fever. CXR: Improved congestive changes. No superimposed pneumonia or overt congestive failure. Cr 186. Treatment:  oxygen, refused remdesivir, Discharged home.
This case was reported by a other health professional and described the occurrence of pain in a 17-year-old female patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced pain in thigh. On an unknown date, the outcome of the pain in thigh was recovered/resolved. It was unknown if the reporter considered the pain in thigh to be related to BEXSERO. Additional details provided were as follows: The pain in thigh lasted for 8 days.
When coming to get his 2nd dose of the Pfizer vaccine, patient said the 1st dose in series (Pfizer) caused underarm swelling in his lymph nodes. It lasted for 1 week then abated. He thought it came back the week after. He said it was uncomfortable.
Some nausea, she threw up once. Overnight she experienced multiple bouts of involuntary shaking of the legs, primarily the left leg. The next day, left leg was extremely weak, could barely lift, only able to slide the foot along. Needed physical assistance in ambulation as a result. Some shaking of left hand as well.
Pt reported to the pharmacy day after getting shingrix. Pt had rashes on her arms and abdominal. Pt started getting the allergic reactions few hours after the immunization.  Pt had no signs of shortness of breath (or any medical emergency situations). Pt has been taking benadryl for alleviate any allergic reaction symptoms.  Pt knows to contact 911 if she experiences shortness of breath (or throat closing) or severity of rashes worsens.
Fever 37.8 chills injection site pain; Fever 37.8 chills injection site pain; Fever 37.8 chills injection site pain; This is a spontaneous report from a contactable nurse, the patient. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK9231) solution for injection in the left arm on 31Dec2020 at 08:15 (at the age of 50-years-old) as a single dose for COVID-19 vaccination. Medical history included Type2 DM (diabetes mellitus), hypertension, obesity, gout and Covid-19. Concomitant medications included unspecified medication(s). The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was previously diagnosed with COVID-19. On 01Jan2021 at 14:00, the patient experienced fever 37.8, chills and injection site pain. Treatment was provided for the events fever, chills and injection site pain included acetaminophen (TYLENOL 650mg). The outcome of the events fever, chills and injection site pain was recovered in Jan2021. Since the vaccination, the patient has not been tested for COVID-19.
HEADACHE, TIRENESS, ITCHING, BURNING SENSATION OF THE SKIN, MILD FINE, GENERALIZED SYMETRICAL RASH, WORSE IN ARMS, CHEST AND ABDOMEN. NOW NO HEADACHE/PAIN IN INJECTION SITE, BUT CONTINUES WITH RASH, BURNING SENSATION AND ITCHING DESPITE SOLUMEDROL INTRAVENOUS ON 10/13/2020 AT DOCTOR'S OFFICE, HYDROXYZINE 25 MG THREE TIMES A DAY, BETAMETHOSNE CREAM SINCE 01/13/2020 AND PREDNISONE 50 MG BY MOUTH DAILY SINCE 1/18/2020
UNEXPECTED THERAPEUTIC EFFECT; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included cold sore of herpex, and concurrent conditions included cold sore on lips, and cold sore on tongue.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced unexpected therapeutic effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected therapeutic effect was not reported. This report was non-serious.
Shingles; This case was reported by a consumer and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received in 2015).   In September 2018, the patient received the 1st dose of Shingrix. In November 2018, less than 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication. In November 2018, patient came down with a very mild case of the shingles. The patient enquired when it was time for them to get the second Shingrix injection in January 2019. The patient was advised not to have it because of recent bout with the shingle. For tolerance of 2nd dose of vaccine, refer case US2019AMR154678. The reporter consented to follow up.
Low grade fever, severe headache, muscle/body ache, upset stomach, pain in arm of injection site and rash and itching at injection site
PATIENT REFERS CHEST PAIN, HEADACHE, SHORTNESS OF BREATH AND HYPERTENSION APROXIMATELY 4 HRS AFTER VACCINE ADMINISTRATION. PATIENT REFERS HE STILL IS EXPERENCING FATIGUE AND RAPID HEART BEAT(TACHYCARDIA) 11/10/2009 ED record for 10/28/2009 patient with c/o's sob, headache, chest pain. EKG abnormal, cardio consult, Tx: IV, Nitropaste, plavix. Dx atypical chest pain
Itchy Rash, All over body, started on wrists and top of hands both sides; now on arms, stomach, thighs, face, and back.
Petechiae, bilateral, fingers to elbows was bright red on 04/12/2021 but became dark as week went on.  I have photos.  T his is not just a few spots but heavy and noticeable by others.   Then Saturday night 04/17/2021 I dozed off on the sofa but woke to an incredible headache with jaw and neck pain.  I had dysphagia.  Earlier in the week I had two bad headaches but dismissed them as work.
Noted red swelling rt thigh the evening of the immunization on 4/22. Documented given PCV 13. On exam skin rt ant thigh streak erythematous and slightly raised, no area of fluctuance. DX. cellulitis. Rx clindamycin.
Left thigh cellulitis beginning within 12 hours, post vax, of Prevnar. Observed for 24 hours with erythema and induration with increasing. Given Ancef and started on Keflex 48 hours, after injection. (Had 2nd Hep-A/MSD/1559K/IM/RL on 3/19/2000)
Initial report received from a nurse on 26 March 2007. A 37 year old, female patient (with on known allergies) developed a "persistent knot"at the injection site (firm nodule about the size of a quarter), 5 days after she received Adacel (lot number C2720AA) sub-cutaneously (instead of intramuscularly) on 15 March 2007. She also has a red, painful 20 mm area at the injection site. At the time of the report, she had not recovered. This case has the same reporter as case 2007-00964.
Patient turned pale after vaccination; fainted without injury. Completely recovered within minutes with hydration and support.
Sore arm at injection site; Low grade fever; Body aches; Sore face along jawline and cheekbones 12-24hrs after injection.; Swelling in face (cheekbones & side of upper right lip) 1.5 days after injection.; Chills; This is a spontaneous report from a contactable consumer, the patient. A 44-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0T59) via an unspecified route of administration in the left arm on 21Apr2021 at 10:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included filler done on face on Oct-2019. Concomitant medications were not reported. The patient previously took (sulfa) Sulfonamide. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 31Mar2021, at 11:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21Apr2021 at 10:45, the patient experienced sore arm at injection site, low grade fever, ache, sore face and swelling in face. The patient reported that she had sore arm at injection site, low grade fever, chills, body aches and started sore face along jawline and cheekbones 12-24hrs after injection. Swelling in face (cheekbones & side of upper right lip) 1.5 days after injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of sore arm at injection site, low grade fever, ache, sore face and swelling in face included treatment with Benadryl on an unknown date. The clinical outcome of the events sore arm at injection site, low grade fever, ache, sore face and swelling in face were recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated medical history data, event (chills), vaccination facility data.
3 inches redness, warmth across, 4 inches length, for 3 days, HA one day, using Advil for pain.  Wednesday tired, pain, tenderness.
tremendous pain in the muscles of her back,f eet, ankles, and arms.; pain in muscle of feet; Joint pain in her legs (both sides)/ lot of pain in her joints; pain in muscle of arm; tired; dizzy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), BACK PAIN (tremendous pain in the muscles of her back,f eet, ankles, and arms.), PAIN IN EXTREMITY (pain in muscle of feet), FATIGUE (tired) and ARTHRALGIA (Joint pain in her legs (both sides)/ lot of pain in her joints) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rheumatoid arthritis.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DIZZINESS (dizzy) and FATIGUE (tired). On 16-Mar-2021, the patient experienced BACK PAIN (tremendous pain in the muscles of her back,f eet, ankles, and arms.), PAIN IN EXTREMITY (pain in muscle of feet), ARTHRALGIA (Joint pain in her legs (both sides)/ lot of pain in her joints) and MYALGIA (pain in muscle of arm). At the time of the report, DIZZINESS (dizzy), BACK PAIN (tremendous pain in the muscles of her back,f eet, ankles, and arms.), PAIN IN EXTREMITY (pain in muscle of feet), FATIGUE (tired), ARTHRALGIA (Joint pain in her legs (both sides)/ lot of pain in her joints) and MYALGIA (pain in muscle of arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.
This spontaneous report was received from a Licensed Practical Nurse, referring to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date, the patients was vaccinated with zoster vaccine live (manufacturer unknown) in error 5 days post its expiration date, (dose, strength, lot number, expiration date and administration route were not provided). No product quality complaint (PQC) was involved. Additional information has been requested.