chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Trouble walking; Joint Pain in his right knee; Mild soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Trouble walking), ARTHRALGIA (Joint Pain in his right knee) and INJECTION SITE PAIN (Mild soreness at the injection site) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Knee injury (Injury to right knee from Football about 60yrs ago.).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced GAIT DISTURBANCE (Trouble walking), ARTHRALGIA (Joint Pain in his right knee) and INJECTION SITE PAIN (Mild soreness at the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (Trouble walking), ARTHRALGIA (Joint Pain in his right knee) and INJECTION SITE PAIN (Mild soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Red, warm, slightly swollen area of 2-3" in diameter that is painful to the touch.  4 days post vaccination- area is still slightly red and warm with minimal swelling.
pt recvd vax & 3 days later died @ home of SIDS; further details have been requested;
She got her vaccine, approximately on 8/29/21 she got red bumps with a blister center.  The skin around it was red and intensely itchy and was very painful.  She went to the doctor on 5/6/21 and she treated her for possible insect bites.  Then later on she treated for possible bacterial infection and she did a test as she was getting large boils the size of a nickel and she a culture from the boil.  She had her on antibiotics, then she did a culture of a boil and was informed that she did not have a bacterial infection.  She then went to a dermatologist who did a biopsy for bolus pemphygoid and it was negative x2 from the boils, but large blisters and he thought it was insect bites.   However, no one in the else was getting bites, and she was wearing full protective closing and not even going outside thus not exposed to any insects.   She continued to get the large blisters to approximately 9/20/21.   She has not had any since 9/20/21.  She did have Doxycycline and found out that she was allergic to it.  She had been taking all sorts of antibiotics for this reaction, but was still getting the blisters up until September.    She did not inform them that she had gotten the vaccine, but indicated that she could possibly have had a reaction.  They did call her back and they told her to fill out the report online, which she tried to do and was unsuccessful as it kept timing out on her.
Chills, joint pain, body aches, syncopal episode, diarrhea, headache, malaise
This case was reported by a consumer via other manufacturer and described the occurrence of heart pounding in a 75-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SOMATULINE for an unknown indication. On 7th December 2018, the patient received the 1st dose of SHINGRIX and SOMATULINE at an unknown dose and frequency. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced heart pounding, tiredness, nausea, feeling hot and feeling unwell. On an unknown date, the outcome of the heart pounding, tiredness and nausea were unknown and the outcome of the feeling hot and feeling unwell were recovered/resolved. It was unknown if the reporter considered the heart pounding, tiredness, nausea, feeling hot and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: On 7th December 2018, the patient received SOMATULINE DEPOT. After receiving SHINGRIX, the patient experienced that her heart was pounding out of her chest, she was tired, nauseous (but did not throw up) and she felt hot for 3 to 4 days. The patient stated she did not go anywhere and did not feel like doing anything for about 3 to 4 days. No further follow up was anticipated.
pt recv vax 1015AM & was taken home & slept for 1hr when pt woke up was fussy, cried straight x 1hr;would not take bottle milk or water;pt came to MD ofc around 330PM crying, fussy;f/u not as high pitch crying & t101;
flu; Initial information received on 11-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who experienced flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.    It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
My period is always regular and on time. In lieu of a regular period that was due a few days after the vaccine was administered, I only experienced light spotting.  It was very concerning to me. Another extra heavy period came just a few weeks later. I found this to be very troubling. I called my OB?s office. They could not tell me why the vaccine is causing so many women to report period changes, but they indicated that lots of women are experiencing them. They did not document anything from me, and assured me that most women?s cycles *should* be back to normal ?in a couple of months?. I also found this to be troubling. If it?s not being tracked, then it?s not being  accurately reported or studied.
6 x 5 1/2" reddened area from where flu shot was given yesterday hot to touch. Allergy PCN. Z pack #6 po given. RTC - IV & week PRN.
I started becoming hoarse about 10 minutes after receiving vaccine. I left after 30 minutes and while I was driving home about 5 minutes later I became short of breath and took benedryl 25 mg which I had on the seat next to me in the car.  By the time I got in the house, approximately 40 minutes after receiving vaccine dizziness and palpitations started.  I checked my heart rate on O2 sat, 99% on room air, and HR low 100s. I did complete appointments with patients that afternoon but had trouble thinking,  was dizzy, and hoarse. the benedryl helped the SOB. I told the clinic manager the next time I received the 2nd dose of the vaccine I would need to take off from work due to the reaction. I was off 4 four days after receiving the vaccine and had fatigue, nausea, chills, and SOB. During the 4 days off I doubled my corticosteroid dose from 2 puffs daily to BID due to needing to use albuterol rescue inhaler every 4 hours and took benedryl as needed. I am still having trouble breathing and needing to use breakthrough rescue inhaler and benedryl along with cetirizine that I take daily which is why I reached out to Moderna today and scheduled an appointment with allergy/immunology to assess safety of receiving 2nd dose of vaccine.
This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions of the patients were reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored does of M-M-R II (lot # K024824, expiration date 02-DEC-2016; lot # L001336, expiration date 13-JAN-2017; lot # K016153, expiration date 24-SEP-2016) (dose and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
I got the booster at about 5:20 pm on Thursday May 12, 2022. The next morning there was a very red largish circle where the shot had been given. It was very hot and hard. That afternoon (Friday) I developed a bad headache that lasted until Saturday morning. I have slept a lot for a couple of days and I am still pretty tired. The red area got a lot larger but is now less red, but still there (Tuesday). It has been itchy from the beginning.
Pfizer bottle with 1 last dose inside was mixed with normal saline as a new unpunctured bottle.  So, the patient ended up getting a diluted dose.  The patient was observed for 15 minutes per protocol with no reaction.  Upon discovery, the patient was contacted immediately as well the district and pharmacy manager about the incident.  The patient came back for the correct dose with no further incidence.
Diarrhea; Nausea; muscle pain in lower back; Can't stand up; Arm soreness; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), MYALGIA (Muscle pain), BACK PAIN (muscle pain in lower back), DYSSTASIA (Can't stand up) and DIARRHOEA (Diarrhea) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and MYALGIA (Muscle pain). On 07-Feb-2021, the patient experienced BACK PAIN (muscle pain in lower back) and DYSSTASIA (Can't stand up). On 08-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Arm soreness), MYALGIA (Muscle pain), BACK PAIN (muscle pain in lower back), DYSSTASIA (Can't stand up), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD21-023037 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-023037:
He received the Tdap and was supposed to receive the Dtap . There have not been any reactions at this time.
No additional AEs; temperature excursion for VARIVAX. Product administered after TE; This spontaneous report was received from a healthcare business professional (HBP) and referred to a patient of unknown age or gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reaction/allergies were not reported.   On 16-MAR-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dosage form, lot #W031811, expiration date: 05-OCT-2024, administered for prophylaxis (strength and route of administration were not provided) after the vaccine was involved in a temperature excursion (product storage error).  The storage temperature of the varicella virus vaccine live (oka/merck) (VARIVAX) was 14.5 degrees Celsius for a time frame of 19 minutes and 17.2 degrees Celsius for a time frame of 19 minutes. There was no previous temperature excursion. No additional adverse effects were reported.
Patient started to have flecks of blood in stool for about 24 hours and intermittent bouts of abdominal rigidity and irritability/crying. No emesis. No fever. Sent for STAT limited abdominal ultrasound, but no current sign of intussusception. Patient has had mucus in stools since birth, per mom, and frequent loose stools, but is being breastfed exclusively.
Bullseye on stomach area. Given antibodies on 5/10/99 for five to six weeks. No further problems until fall of 2002.
Body aches; Fatigue; This case was reported by a physician via sales rep and described the occurrence of general body pain in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced general body pain and fatigue. On an unknown date, the outcome of the general body pain and fatigue were unknown.   It was unknown if the reporter considered the general body pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of shingrix and experienced body pain and fatigue. The reporter did not consent to follow up. This case has been linked with case US2019AMR208451, reported by same reporter.
Within 30 minutes, I turned bright red - my face and my forearms. Not a rash or raised rash. It was a deep red flushing. I took a dose of oral Benadryl it didn't go away. It felt like a sunburn.  I had a headache starting at the back of my head. 1st and second day, I had pain in my joints. Not muscular pain. It came and went the joint pain - behind my left knee was hurting really bad and then it went away. Then my right wrist would start hurting and then it would go away, etc. The second day, the headache was more mild - like a mild pressure in my head. The redness was still there - the red face and red arms. My left arm at the site was cherry red and about the size of two inch circle and somewhat raised. The third day, my headache was worse. It was not like a normal headache but an overall pressure in head. Pink and a bit larger but didn't  hurt as  bad on arm- the redness continued for six days on my face. The headache lasted 14 days straight - Motrin, ice, heat and extra sleep was tried for treatment. On 15th day it started to let up. On 16th day, it was very mild headache. On the 17th day, it was a full blown headache again. Day 18 it was gone. On the second week, I had mild pain in my stomach and then that went away. On day 3, I had about an hour - twice that day - where I was short of breath and then it went away - it was just that day - about noon and at night. I took Benadryl and when I woke up that didn't  happen again. Doctor called on day 12 - when my headaches weren't going away. He took some labs. My labs were normal except thyroid (and I already have a condition for my thyroid). Dr. gave me a medication for headache but I didn't take it - it had a possibility of making me tired and I didn't want to take it.
pain in arm; Burning; hot; pain in neck, wrist, hip, leg; pain in neck, wrist, hip, leg; Dizziness; pain in neck, wrist, hip, leg; pain in neck, wrist, hip, leg; Nausea; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), BURNING SENSATION (Burning), FEELING HOT (hot), NECK PAIN (pain in neck, wrist, hip, leg) and PAIN IN EXTREMITY (pain in neck, wrist, hip, leg) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm), BURNING SENSATION (Burning), FEELING HOT (hot), NECK PAIN (pain in neck, wrist, hip, leg), PAIN IN EXTREMITY (pain in neck, wrist, hip, leg), DIZZINESS (Dizziness), the first episode of ARTHRALGIA (pain in neck, wrist, hip, leg), the second episode of ARTHRALGIA (pain in neck, wrist, hip, leg), NAUSEA (Nausea) and PYREXIA (low grade fever). At the time of the report, PAIN IN EXTREMITY (pain in arm), BURNING SENSATION (Burning), FEELING HOT (hot), NECK PAIN (pain in neck, wrist, hip, leg), PAIN IN EXTREMITY (pain in neck, wrist, hip, leg), DIZZINESS (Dizziness), the last episode of ARTHRALGIA (pain in neck, wrist, hip, leg), NAUSEA (Nausea) and PYREXIA (low grade fever) outcome was unknown.            No Relevant concomitant medications was reported.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.   This case was linked to MOD-2021-090320 (Patient Link).
Pt has red, pinpoint, non-raised rash on chest area- started after day zero rabies PEP and worsened after day 3 imovax received on 8/20/2017.
This spontaneous report was received from a registered pharmacist via a company representative, who refers to an adult female patient between 20 and 21 years old. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On an unknown date in 2013 (reported as approximately 5 years ago), the patient received the complete vaccination series of three doses of GARDASIL 9 (lot #, expiration date, dose, and route of administration were not provided for all) for prevention of human papilloma virus (HPV). On an unknown date in 2013 (reported as approximately 5 years ago after complete series of vaccination), the patient developed liver failure. The outcome of the event was unknown. On an unspecified date, after developing liver failure the patient died. Cause of death was not provided. It was unknown if autopsy was performed. The causal relationship between the events and therapy with GARDASIL 9 was not provided by the reporter. Upon internal review, the event of liver failure was determined to be medically significant. Reported Cause(s) of Death: Unknown by reporter.
Day # 7at appx 11PM, left  arm started itching, swelling and sore. Woke up on the 12th to find a "goose egg" size area at injection site. It is now 8/12/21 at 5:27PM, site continues to itch with redness and swelling which has not resided.
a bit tired; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on unspecified date, as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after taking Pfizer COVID vaccine, the patient felt a bit tired. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
She got the vaccine, didn't hurt at all, muscle tightened up but did not bother her at all.  Next day a little soreness.  Then 9 days later noticed and rash that was very red, and then fanned out like a Christmas tree 3", and 4" wide and very painful, inflamed, under the arm and toward the breast area and down to the elbow and itchy.  She called her doctor and was instructed to take Benadryl and also Tylenol.  She used cold compresses and by Monday it still hurt, and could rub it.  It presently does not hurt to touch, but does have a little tenderness on the elbow, but is able to cut her grass, do her yardwork, etc.
Tightening of chest. Wheezing in upper lobes. Pt reports nausea. Pallor. Administer, oxygen at 2 L NC. Ice applied to site. Monitored vital signs 10 min intervals called 911.
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of injection site redness in a 25-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to CIPRO, allergy to KEFLEX, latex allergy and penicillin allergy. On 30 August 2010 the subject received a dose of BOOSTRIX (unknown route, left arm). On 1 September 2010, 2 days after vaccination with BOOSTRIX, the subject experienced injection site redness, swelling injection site, erythema of ear, burning ear, red blotches on face and red spots hands. The subject was treated with BENADRYL. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX. The healthcare professional reported that a latex free 3cc syringe, 25 gauge needle, by Select Latex Free Medical Product, was used. The healthcare professional reported that the physician did not believe it was from a food allergy.
The next morning patient had pain on backside of Right knee. It was worse then in afternoon, it started to pain in Left backside of neck. For few days it felt that way. After 1 week knee pain is getting better but still neck pain is there. Patient is using ALEVE for the pain.
I had to get my shot. I was taking care of my father. I went to celebrate my father in laws 80th birthday. My brother in-law was the one that gave me COVID-19 and he wasn't vaccinated. At first they wanted to put me in the hospital but I didn't want to be admitted because I have too many health conditions to be in the hospital and the ER doctor did agree. So I went home and Zinc 220mg Sulfate which had to have 50mg of zinc one tablet two times a day. Vitamin C 500mg 2 tablets two times a day Vitamin D3 3000IU 1 tablet once a day Aspirin 325 one a day and all this was to be done for 10 days nebulizer as well as needed I am still very fatigue worse than usual, My RA is worse than it was before and the medication isn't working.
Pain on site of injection that radiate to shoulder and lower arm, sleeplessness, hardly can walk, can't dress, can't hold anything with the arm. Went to MD, only APAP prescribed. Hard to take shower.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 28-JUN-2017, the patient was vaccinated with the first dose of GARDASIL 9 lot #M036059 with expiration date of 03-JUN-2019 for prophylaxis (dose, route of administration and anatomical location were not reported). On 26-SEP-2017, the patient was vaccinated with the second dose of GARDASIL 9 lot # N002720 with expiration date of 12-MAY-2019, 0.5 ml, intramuscularly for prophylaxis (anatomical location was not reported). No adverse effects were reported.
Information has been received from a health professional concerning a male physician who was vaccinated with a dose of zoster vaccine live (Oka/Merck). Subsequently the patient developed erythematous bump at injection site. The patient recovered on an unspecified date without any medical treatment. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Day period started, back and stomach pain more intense than in years.  Also, stomach heaviness, headache.  Period began at 11 pm.  Today is day 2 and the intensity is the same as yesterday.  Typically, I have mild cramps.  This is more painful.
I developed shortness of breath and fatigue on June 11, 2022. I had an EEG on the following Friday that showed that my Mitral Valve Regurgitation had worsened and was now severe. My symptoms caused me to be scheduled for surgery on August 23, 2022. While I was waiting for surgery, I had worsened symptoms that now included anemia and elevated inflammatory factors. During my surgery they determined I had endocarditis. I had a month of antibiotic to treat it. As of today, I have no symptoms.