chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Weakness; Nose running; Feeling Unwell; This is a spontaneous report from a contactable consumer (parent) or other non-health care professional. A male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry Date: unknown) via an unspecified route of administration on 17Feb2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced chills, weakness, nose running and was feeling unwell. Reporter stated, he was at work so reporter was assuming he got off of work and was calling to share that he was not feeling well, feeling very weak. Reporter called to inform that he was having some type of symptoms. Limited information was available over the call. Outcome of the events were unknown.  Information of lot/batch number has been requested.
Shingles on trunk; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 2Y9R4, expiry date 28th June 2021) for prophylaxis.   Concomitant products included chemotherapy, nos (Chemotherapy).   On 28th March 2019, the patient received the 1st dose of Shingrix .5 ml. On 5th April 2019, 8 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated on left arm and was diagnosed with shingles on his trunk. The patient had been receiving chemo therapy treatments starting in November 2018. His last round was on 18th March 2019 to 22nd March 2019. The reporter consented to follow-up.
me too i dd twice this year with no adverse event; Initial information received on 27-Sep-2021 regarding an unsolicited valid non-serious case received from via consumer non health care professional (under reference number: US-SA-SAC20210929000207).  This case involves Adult and unknown gender patient who was administered an extra dose INFLUENZA VACCINE (extra dose administered).  The patient's medical history, medical treatments, vaccinations, concomitant medications 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 unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to extra dose administered (latency: same day).  It was reported that "Hello, The following potential OSF has been found as a public comment on an Influencer post related to Flu Shot Fridays. Product name was not provided. Since this is a public post on the Sanofi flu shot campaign Flu Shot Friday we are assuming the consumer is referring to the Sanofi flu vaccine".  At the time of reporting, 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 the 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.)
w/in 24hr p/3rd hep b vax devel a rash;no fever-rash -lace type appears-face, trunk-arm-legs brightens w/heat exp <5 days >now;
#1 ROTATEQ given 7/29/08.  Developed diarrhea multiple times/day which has persisted >2 weeks.  Stool + for rotavirus.
Immediately felt rush of pain to head, head pressure, not dizzy but very off, hard to stand; eventually walked away from retail clinic and felt bad for 1 day - had local arm swelling, pain, redness for 1 week.
pt recvd vax;was adm to hosp w/ dx of a "mild case" of GBS;pt hosp for 5 days & was discharged w/ urinary catheter;
Received the vaccine and about 2 hours later I felt an odd sensation in my stomach, this traveled to my head, everything felt like it was moving and this lasted for about 2-3 minutes. After that everything felt fine until later in the evening when I got up to use the bathroom in the middle of the night I walked in to the wall 3x on the way to the bathroom. When I got up the next morning I could not move without feeling extremely sick to my stomach and everything feeling as if it was in motion. I was diagnosed that day at the Dr with vertigo. I followed up with my Dr the following week and sent to PT as I was not feel better. The Physical Therapist determined that I did not have vertigo and could not pin point what was wrong except that I did have balance and motion issues. It has been about 7 weeks since the shot and I continue to have "vertigo" symptoms. I get dizzy and off balance with no explanation. I took several weeks of PT without resolve. I have been to the Neurologist without answers and can only trace it back to starting the day of the Covid shot.
Patient stated that he still experienced pain and soreness in arm where he received the Td vaccine whenever he exercised and that it had been 4 days since he got vaccinated. Was examined by Dr. No pain during examination. Pain only occurring after exercising. Advised to not exercise for a few days. To return to clinic on Monday if pain persists. Patient referred to Vaccine Information Statement for Td that some pain is normal after Tetanus vaccine.
"I do not have full range of motion, I cannot sleep on that shoulder, and that arm hurts in many positions.  Several days I end up taking either Motrin or naproxen at the end of the day so that I can sleep." per patient email to the doctor.
Moderate allergic reaction; Felt light headed and dizzy; Cough; dry throat; Scratchy throat; Nose Tingling; did not sleep well; O2 saturation levels fluctuating from 97-86; A spontaneous report was received from nurse concerning a 56-year-old female patient who felt lightheaded and dizzy and experienced moderate allergic reaction, cough, nose tingling, dry and scratchy throat, unwell sleep, and oxygen saturation fluctuations.  The patient has past medical history of Chronic obstructive pulmonary disease (COPD) and emphysema. No relevant concomitant medications were reported.  On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273, for prophylaxis of COVID-19 infection.  On 29 Dec 2020, immediately after the vaccine shot, she felt lightheaded and dizzy. She experienced nose tingling, cough and her throat was dry and scratchy. Her symptoms were considered severe by clinic staff and the patient was taken to the emergency Room (ER). Her oxygen levels were reported to be fluctuating from 97-86. The reaction was considered a moderate allergic reaction. Treatment with diphenhydramine and steroid shot was given. The patient condition improved and was discharged from the ER with prescription for steroid taper. The patient did not sleep well and did not contact the provider about any symptoms.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the events, moderate allergic reaction, felt lightheaded and dizzy, cough, nose tingling, dry and scratchy throat, unwell sleep, and oxygen saturation fluctuation was unknown.  The causality assessment for the events, moderate allergic reaction, felt lightheaded and dizzy, cough, nose tingling, dry and scratchy throat, unwell sleep, and oxygen saturation fluctuation was not provided.; Reporter's Comments: This case concerns a 56-year-old female patient with a  relevant medical history of COPD and emphysema who received their first of two planned doses of mRNA-1273 (Lot 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient experienced the serious unlisted event of Hypersensitivity, and non--serious unlisted event of Dizziness, Cough, Dry throat, Throat irritation, Poor quality sleep, and Oxygen saturation decreased. The events occurred on the same day after first dose of mRNA-1273, lot # unknown. Treatment for the events included diphenhydramine and steroid shot. Based on the temporal association between the use of the product and the events occurring after receiving the vaccine, a causal relationship cannot be excluded and the events are considered possibly related to the product.
After vaccine was sick with flu like symptoms and fever for 1.5 days with malaise.  Starting yesterday (7 days) post vaccine, injection site has swollen and is very red and hot. Have full body hives and itching. Pain from arm going into shoulder and neck.
Pt presented the day after vaccination with warmth, redness and swelling down to elbow of left arm. He is employed at local hospital and had already been evaluated by a coworker. They had marked the extent of the reaction and advised him to take some Benadryl and watch for further progression. They said they would prescribe an antibiotic if it progressed beyond elbow
Sore arm, headache for two days Vomiting for 4 days Diarrhea one week Second week, occasional diarrhea and tired Third week, occasional diarrhea and tired
I received the Moderna Bivalent booster for COVID-19 on 9/19/2022. On 9/24/2022, I had a very slight cough and very slight fatigue. I was visiting a friend, so I took 2 home antigen tests, and both yielded positive results. I isolated and only visited with my friend outdoors. I was fatigued and spent much of the time sleeping. I had a lot of nasal mucus discharge, but I never developed a fever. On 10/2/2022, I took another home antigen test and got a negative result, and I was then able to fly home.
Patietn recived J & J vaccine early August and within 2 weeks became SOB. He presented to Medical center after syncopal episode and had acute thrombosis of RCA on 9/25 /21 . He underwent PCI and thrombectomy . He was noted to have Cardiomyopathy at this time with EF < 20% . Several hours later while in the ICU he had siexzure followed by PEA arrest with ABG Po2 28 ( presumed pulmonary embolus ) and was pronounced dead at that time
Fever, redness, swellng. Redness on bicep and tricep ara only, from shoulder to elwo. Painful x2 days.
Pt recvd 1 dose of Engerix-B; 18JUN92 exp swelling of lips, SOB, nausea & vomiting;
Information has been received from a consumer concerning her 12 year old daughter with no medical history and drug allergies who was vaccinated with three doses of GARDASIL (lot number unavailable) on unspecified dates.  There was no concomitant medication.  One month ago the patient experienced a rash around her eyes.  At time of reporting, the patient did not recover.  The patient was seen by her eye doctor for medical attention.  No further information is available.
OFF LABEL USE; PRODUCT ADMINISTERED IN INAPPROPRIATE AGE; This spontaneous report received from a parent concerned a 16 year old female. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced product administered in inappropriate age, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product administered in inappropriate age and off label use was not reported. This report was non-serious.
On May 27, 2021 I went in for my first OB appointment. I was 12 weeks pregnant. At that time I was told that the baby was measuring in the 11th percentile. After my anatomy scan on June 9, 2021 I received a phone call on June 12 from the provider stating that the baby was still in the 11th percentile. When I asked what that could mean, she stated that there could be something wrong with the placenta that it?s not providing the nutrients that the baby needs.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The reporter stated that their facility had not been able to download the digital data logger, they had been put on hold at the moment. There had been no power outages that would have impacted the Moderna vaccine.  It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.   This case was linked to MOD-2022-501575 (Patient Link).
This case was reported by a consumer via sales representative and described the occurrence of adverse reaction in a currently 38-year-old female subject who was vaccinated with influenza vaccine (unspecified) (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received a dose of influenza vaccine (unspecified) (unknown details). At an unspecified time after vaccination with influenza vaccine (unspecified), the subject experienced adverse reaction. Per the reporter, she "had an adverse reaction to the flu vaccine years ago." No other details were provided. At the time of reporting the outcome of the event was unspecified.
A little while after I received the vaccine when I would lay down and then sit up, the room would spin and when I would try to get up I would feel l like I was going to fall over. The other times during the day when I was sitting the same thing would happen. It would come in waves. I don't remember how long it lasted. It could have been a month or moth and a half. Eventually I didn't notice it anymore. I think it went away. A week and a half to 2 weeks after my symptoms began I called the my Dr. office and made an appt. They said it probably wasn't related, but I think it was. She also said I had post nasal drip. I was to have a follow- up a week later but made it late to the office and they couldn't see me. I didn't reschedule.
No signs or symptoms reported; temperature excursion; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On an unknown date in 2021, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml, lot number S021456 with expiration date of 25-FEB-2022 (route of administration and anatomical location were not provided) for prophylaxis, that on 06-JAN-2021 was exposed to a temperature of 1.6 degree Celsius (°C) during a time frame of 8 hours. Data logger was not involved. There were no previous excursions reported. No adverse events were reported.  As of 18-MAR-2021, no further information was available..
The same day, I was exhausted. It lasted 2 days. After that, on the 2nd or 3rd day after my shot, my right calf began to hurt. I knew it was connected to the vaccine, but I figured it would go away. Once the information came out about blood clots and my calf still hurt and didn't get better, I decided to go and get it checked out.
thermo skin reaction; mark that hurts; mark that itches; Colour was pink first and red after 70 hours; Patient received 3rd dose without being immunocompromised and said it was an off-label dose; This spontaneous case was reported by a nurse and describes the occurrence of FEELING HOT (thermo skin reaction), VACCINATION SITE PAIN (mark that hurts), VACCINATION SITE PRURITUS (mark that itches), VACCINATION SITE ERYTHEMA (Colour was pink first and red after 70 hours) and OFF LABEL USE (Patient received 3rd dose without being immunocompromised and said it was an off-label dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045C21A, 032L20A and 032L21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Allergic bronchitis (Has been experiencing this condition for 3 years.). Concomitant products included DEXAMETHASONE ACETATE (DECADRON [DEXAMETHASONE ACETATE]) and TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) for Allergic bronchitis.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, the patient experienced FEELING HOT (thermo skin reaction), VACCINATION SITE PAIN (mark that hurts), VACCINATION SITE PRURITUS (mark that itches), VACCINATION SITE ERYTHEMA (Colour was pink first and red after 70 hours) and OFF LABEL USE (Patient received 3rd dose without being immunocompromised and said it was an off-label dose). On 24-Sep-2021, OFF LABEL USE (Patient received 3rd dose without being immunocompromised and said it was an off-label dose) had resolved. At the time of the report, FEELING HOT (thermo skin reaction), VACCINATION SITE PAIN (mark that hurts), VACCINATION SITE PRURITUS (mark that itches) and VACCINATION SITE ERYTHEMA (Colour was pink first and red after 70 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Follow-up received on 24-SEP-2021 : start date for dose updated and start date of event changed to 24-SEP-2021
Itching, hot, redness, soreness at the site of injection was noted on 02/27/2002. Induration extends 1 inch from shoulder down approx. half way to elbow, followed 3 inches of redness aroused area. These symptoms lasted till 03/01/2001 am, pt reports the symptoms resolved after Benadryl was taken.
Patient vaccinated with Covid vaccinations and admitted to hospital with covid symptoms.  Patient admitted with acute kidney injury, dehydration, hypotension, and pneumonia due to covid.
Information has been received from a 72 year old male with a history of prostate cancer, skin cancer and drug reactions/allergies to FLOMAX and morphine who on 11-JUN-2010 was vaccinated with a 0.65 ml ZOSTAVAX (Merck). Concomitant therapy included doxazosin mesylate. On 16-JUN-2010 (also reported as five days later) the patient experienced a rash on one of his legs above the "sockline" and then the other leg. The patient did not seek any medical attention. The patient's rash on one of his legs above the "sockline" and then the other leg persisted. Additional information has been requested.
I just wanted to report this interesting side effect. I had very noticable brain fog / confusion the following morning, 2/26/21 that lasted only a few hours.  I could not function well at work - had trouble problem solving and doing my job working on the phone and computer, making mistakes and communicating poorly.   Really, no other side effects.  I have been fine since.
The next early pm I went to the b/r and had a  "dizzy spell " ansd fell off the toilet in my b/r. I was conscous but unable to get up. My daughter called EMT  and they came and put me on the couch. I did not go to the ER because of the pandemic . My speech was slurred.
used to get sore after the shot , did not feels; Initial information received on 12-Feb-2022 regarding an unsolicited valid Social Media non-serious case received  from  consumer/non-hcp via social media.  This case involves an unknown age and  gender patient who reported used to get sore after the shot , did not feels ,while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (unknown dose, formulation, via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date, the patient reported that she/he was wondering if it was a flu shot or water, she/he used to get sore after the shot , does not feels (pain) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (used to get sore after the shot , did not feels).  At time of reporting, the outcome was Unknown for the event used to get sore after the shot , did not feels.
pt to ED with increasing creatinine, worsening SOB and cough; found to be positive for COVID; given Dexamethasone;O2 supplementation; pneumonia; renal and respiratory failure worsened; ICU; on Vapotherm; given ABX; O2 requirement increased and pt was placed on comfort care; she passed away in the hospital
Pt was given the pediatric/adolescent dose of the Hepatitis A vaccine, instead of the adult dose. This was discovered about 5 minutes after pt was given the dose, by another medical assistant. Pt was told what happened, and tolerated the injection fine without complications.
Post second shot - fever, chills, muscle and joint aches, fatigue, swollen glands, headache, injection site rash and pain
PATIENT IS COMPLAINING OF ON GOING INJECTION SITE PAIN THAT SHE DESCRIBED AS VERY PAINFUL AND TENDS TO WAKE HER UP AT NIGHT. SHE HAS NOT HAD ANY TREATMENT FOR THE PAIN AND IS MAKING AN APPOINTMENT TO SEE HER DOCTOR TO DISCUSS A REMEDY.
pt recvd vax & w/in 1 wk follow vax exp migratory arthritis;arthritis traveled from joint to joint;sx gradually got worse to the point of being very severe,then gradually dec to the present;