chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse events were reported; the consumer's son received a fourth dose of GARDASIL 9; This spontaneous report has been received from a consumer referring to a 25-year-old male patient. The patient's pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.  On 28-DEC-2015 and 15-FEB-2016, the patient was vaccinated with the first and second 0.5 milliliters (ml) doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) respectively (both with lot number L037339, which has been verified to be valid for syringe formulation, the expiration date was reported as "08-FEB-2018"; however, upon internal verification was established as 09-FEB-2018). On 29-JUL-2016, the patient received the third 0.5 ml dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number L019287 has been verified to be valid for syringe formulation, with an expiration date on 14-SEP-2017). The three doses of the vaccine were administered as prophylaxis (routes of administration and anatomical sites of vaccination were not provided).   On approximately 04-AUG-2021 (reported as "a few weeks ago, maybe the 4th (AUG2021)"), the patient was vaccinated with a 0.5 ml fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (extra dose administered) (formulation, route of administration, anatomical site of vaccination, lot number, and expiration date were not provided).   No additional adverse events were reported (no adverse event). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: L037339; expirationdate: 09-FEB-2018; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
non-visible lump with heat, on the shoulder of the right arm around the injection site; non-visible lump with heat, on the shoulder of the right arm around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (non-visible lump with heat, on the shoulder of the right arm around the injection site) and VACCINATION SITE WARMTH (non-visible lump with heat, on the shoulder of the right arm around the injection site) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     Concomitant products included VITAMIN 15 for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced VACCINATION SITE MASS (non-visible lump with heat, on the shoulder of the right arm around the injection site) and VACCINATION SITE WARMTH (non-visible lump with heat, on the shoulder of the right arm around the injection site). At the time of the report, VACCINATION SITE MASS (non-visible lump with heat, on the shoulder of the right arm around the injection site) and VACCINATION SITE WARMTH (non-visible lump with heat, on the shoulder of the right arm around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
After I got the vaccine I felt very weak and nauseous. I laid on bathroom floor to calm myself. I started feeling hot and my heart started pounding. 5 days later my blood pressure spiked 175/102 it was 4:30AM so I waited until the Dr.'s office opened and they told me to go to urgent care. Then I was sent to ER to have test run.
Patient did well with the first two doses, received the booster and two hours after he passed away.  According to the wife, he was alright in the two hour time frame post vaccination. He went shopping and showed no signs of anaphylaxis or intolerance.
pt was given till 1130PM started w/crying & fever 102;APAP given 1AM crying,vomited 3x-t103;MD notified motrin given 130AM-2:30 fever 100.8 slept till 7AM;t101 APAP given;
Got sick; Infected section; Pain; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick), INFECTION (Infected section), PAIN (Pain) and MYALGIA (Muscle aches) in a 47-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got sick), INFECTION (Infected section), PAIN (Pain) and MYALGIA (Muscle aches). At the time of the report, ILLNESS (Got sick), INFECTION (Infected section), PAIN (Pain) and MYALGIA (Muscle aches) outcome was unknown.            Concomitant product use was not provided by the reporter. Patient was on antibiotics for an infected section
icky; headaches; fatigue; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (icky), HEADACHE (headaches), FATIGUE (fatigue) and PAIN IN EXTREMITY (sore arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.). Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PRURITUS (icky), HEADACHE (headaches), FATIGUE (fatigue) and PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PRURITUS (icky), HEADACHE (headaches), FATIGUE (fatigue) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
temp of 100-101 per pt;indurated rt deltoid area 6"x 3";erythema surrounding induration;concurrent URI;
A non-serious spontaneous report of administration to a 78-year-old had been received from a consumer concerning a male. Neither relevant medical history not concomitant medications have been reported for this patient. The patient received FLUMIST on 25-Sep-2009. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
MD rpt pt recv 1 dose varivax 9/95 & in 5/98 pt devel greater than 50 lesions all over body.
Patient reported feeling nauseous, having hot flash and feeling faint. Went to son's house and became short of breath and began having chest pain around 7pm the night of administration. Patient went to the hospital emergency department and was given aspirin and worked up for a possible heart attack. She was administered other medications but is unsure of medications or dosages. Workup was negative for MI and she was advised by the physician that she likely had a reaction to the vaccine.   Patient was discharged to home with no additional medications or treatment. Patient states she is doing much better as of the time of this report.
I had an existing cold sore that appeared prior to the vaccine, but the next day after the vaccine I developed a red bump that appeared on my top lip under the existing cold sore that had started to go away just a few days prior to getting the vaccine. It was tingling like a cold sore but never turned into one. It didn't go away after about 2 1/2 weeks, so I reached out to my dermatologist who prescribed Mupirocin 2% ointment BID for 10 days, but it was still red.  I was given another Triamcinolone Acetonide .1% ointment to use for another 5 weeks but still the bump never went away. It went down a little but never went away. 7/1 I had another appointment with the dermatologist and was advised to use the Triamcinolone Acetonide ointment again, but this time for 2 weeks on and 2 weeks off once daily and has been since that day but still to date; it's still there associated with tingling from time to time and is still a little red bump there.
A nurse administerd 0.2ml, an additional dose of 0.05ml was offered immediately  to make up the full dose  but parent declined
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Hyperventilation-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild, Additional Details: injection was administered around 230 pm. noticed first adr symptom after 5 mins. Peak w multiple adr indicated above around 10-15 mins. post 15 mins resolved to normal confirmed with emt vital check.
Diffuse, red, splotchy rash all over her torso, upper thighs (front and back), spreading below knees.  Morbilliform in appearance.  Rash does not itch, but it burns per patient report.
This is a spontaneous report obtained from a contactable nurse. The nurse reported similar events for 2 patients. This is the 1st of 2 reports. A patient of an unspecified age, gender and ethnicity received PREVNAR 13 (Lot. M35760, expiration date 01May2017) IM at 0.5 ml single dose at anterior aspect left thigh at 4:15 PM, and polio vaccine (IPV, Sanofi; Lot#: M1453) IM at right thigh, both on an unknown date for immunization. Relevant medical history and concomitant medications were unknown. The patient previously received 3 doses of polio vaccine (IPV, Sanofi; Lot#: M1453) IM at right thigh. On 15Aug2016, the patient experienced reactions such as swelling and welting at the injection site. The patient's arm looked like it was turning into cellulitis. No specific tests and/or treatment was required. The AEs did not require an emergency room or physician visit. Clinical outcome of the events was recovered at time of this report. The reporter stated that the patient did provide to him/her information regarding the reported adverse events with the use of the suspect. The nurse stated there was a reasonable possibility that the event is related to suspect product. The reporter was willing to be contacted again by Pfizer on the reported adverse events. Follow-up (14Sep2016): New information reported from a contactable nurse included: PREVNAR 13 route,  expiration date, dosage, anatomical location, vaccination time; event onset date and outcome; co-suspect polio vaccine added, reporter informed regarding the adverse events; reporter event causality assessment; reporter further contactability.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2016390391 Same reporter/drug, different patient/AE.
1 of 5 pts w/in a 3 wk period who exp cellulitis following immun treated w/ATB (Augmentin for 7-10 days; no cultures taken; pt recovered;
"This patient received the Moderna Vaccine yesterday. She was recently hospitalized for COVID 19 bilateral pneumonia. I saw her in office yesterday and she was doing much better. She got the vaccine and started having severe abdominal cramps and diarrhea around 1 AM this morning.  The diarrhea and abdominal cramps have subsided since then but she has also been having a fever of as high as 103 Fahrenheit.  She has been taking scheduled Tylenol which was able to knock it down to 100.6.  I have recently also added on ibuprofen to help her reduce her temperature.
I had Atrial Fibrillation. I went to the ER but they could not control it with meds, so I had a cardioversion.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received SHINGRIX (batch number B57NG, expiry date 16th September 2021) for prophylaxis. On 28th November 2018, the patient received SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient experienced soreness, redness, and warmth at the injection site about the size of orange. The reported batch number for SHINGRIX was BS7NG, which was changed to B57NG, as per sales data sheet.
SUSPECTED COVID-19 INFECTION (TIGHTNESS IN THROAT, DIARRHEA); This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa allergy, and penicillin allergy, and other pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 16-APR-2021 13:00 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 57 years old. No concomitant medications were reported. On 19-DEC-2022 12:30, the patient experienced suspected covid-19 infection (tightness in throat, diarrhea). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection (tightness in throat, diarrhea). This report was non-serious.
The pt developed herpes zoster. The pts sought unspecified medical attention. Additional information has been requested.
muscle pain for over 2 months; limited arm mobility, using over the counter lidocaine & aspercreame;
3 days after shot developed purulent ring around inj site, 5 days later vomiting and high fever. Pt says she believes she developed a staph infection at injection site which spread to face and ears (pt developed boils in ear and around airline). Fever, vomiting resolved, injection site reaction improving but still there.
First dose administered 21 days before; Headaches; Nausea; Fever; Body aches; Chills; Joint pain; Throwing up; Extreme exhaustion; A spontaneous report was received from a pharmacist concerning a 59 years old female patient who received Modern's COVID-19 vaccine (mRNA-1273) who experienced headaches, nausea, fever, body aches, chills, joint pain, throwing up, extreme exhaustion, and inappropriate schedule of vaccine administration.  The patients medical history was not provided. Concomitant medication included vitamins and female hormones.  On 25 Jan 2021 prior to the onset of the events, the patient received their second dose of mRNA-1273 (lot/batch: 025520-2A) for prophylaxis of COVID-19 infection. First dose might have been administered 21 days before.  On 25 Feb 2021, after 12 hours of receiving the vaccine, the patient experienced headaches nausea, fever, chills, joint pain, throwing up, extreme exhaustion. No Laboratory details provided.   Treatment for the events include paracetamol and antibiotics.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, headaches, nausea, fever, body aches, chills, joint pain, throwing up, extreme exhaustion, were not reported. The outcome of the event, inappropriate schedule of vaccine administration, was resolved on 25 Jan 2021.; Reporter's Comments: This case concerns a 59 Y/O F who had a nonserious unexpected event of Inappropriate schedule of product administration with mRNA-1273 (lot # 025520-2A) with nonserious expected fatigue, fever, chills, nausea, vomiting, headache, pain, arthralgia.  Event onset the same day as the second dose, which was 21 days after the first dose. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
THIS IS A QUALITY EVENT HAPPENED AT THE STORE FOR WRONG SELECTION OF VACCINE. THIS PATIENT WAS SUPPOSED TO GET KIDS PFIZER VACCINE 5 YEARS TO 11, INSTEASD WAS GIVEN PFIZER 12 AND UP GRAY CAP VACCINE (  NO DILUENT NEEDED). THIS WAS DULUTED WITH DILUENT AND GIVEN AT KIDS DOSE 0.2ML ON 02/21/22. STAFF REALIZED ON 02/23/22. ATTEMPTED TO REACH THE PARENTS FOR 2 DAYS IN A ROW WITH OUT SUCCESS. NO ADVERS REACTIONS REPORTED.
Post vax, the patient experienced between 50-250 lesions of chickenpox and a fever of 102F. Unspecified medical attention was sought and it was noted that a wild type virus was isolated from the skin lesion.
headache, achy all over, bruising to under arm, increased fatigue, poor endurance. the morning after is when symptoms started
pt recv vax 16NOV95 & 17JUN96 pt exp breakthrough case of chicken pox which appeared to be a mild case @ time of report;
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients were administered with an expired dose) and PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 019F21A, 030L20A and 025J20A) for COVID-19 vaccination. The patient never been diagnosed with or tested positive for COVID-19. Acute illness at the time of vaccination and up to one month before was reported as unknown. Chronic or long standing health conditions were unknown. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 25-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients were administered with an expired dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 patients were administered with an expired dose) and PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that a few months ago the Vial Expiration Look up Tool displayed 26-Apr-2022 as the expiration date for Lot number: 022J21A, so they administered 10 patients on 25-Apr-2022 with that vaccine, and after that they checked the expiration date again in the tool, the new expiration date is 24-Apr-2022, HCP stated that the expiration date had changed. The date at which the vial was initially stored in the refrigerator was 25-Apr-2022. The vial did not undergo any temperature excursions. No treatments medication were reported.
Sore in the injection site; A spontaneous report was received from a dietician concerning a 26-years-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore in the injection site/vaccination site pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (batch Number: 011L20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.  On 05 Jan 2021, the patient experienced sore in the injection site. On 06 Jan 2021, the patient's arm looks better but symptom was still ongoing. The patient did not receive any treatment.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the event sore at the injection site was not resolved (still ongoing).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Numbness in palms of hands, tingling in both feet, dizziness, neck pain, migraine
Patient received her first Moderna COVID-19 vaccine and fainted within 1-2 minutes.  She was sitting and fell to the floor.  Vital signs remained stable as follows:  12:40pm BP 94/50, pulse oximeter - 97% and HR - 91 laying down 12:43pm BP110/78, pulse oximeter - 98% and HR 97 sitting 12:51pm BP 114/84, pulse oximeter - 98% and HR - 91 standing  Patient was responsive after fainting and reported history of syncope.  She was accompanied to Health Office at the school by wheelchair and family was called to pick her up.
Fever of 102.3 degrees, chills, fatigue, body aches, headache, mental fogginess
I was diagnosed with COVID-19 on July 27th. I was experiencing only mild symptoms. I lost my taste and smell for about a month. I had cold like symptoms runny nose, a slight cough, and a little congestion.
I got my booster shot yesterday (01/20/2022) and I experienced some symptoms which I remembered to have also experienced with the first and probably also the second doses of the vaccine. Soon after I received the vaccine on 02/15/2021 (in the car going home), I was experiencing some loss of feeling in my left forearm. I started moving and rotating my wrist and probably also gently slapping the forearm to maintain feeling. The same thing happened to me some maybe 10 minutes after my booster shot, though I recall it being more severe after the first dose. When I experienced this yesterday it lasted a few minutes or maybe a little bit more. When I was in bed last night, I felt that I was very slightly loosing feeling in part of my face. After moving my jaw around and some gentle slapping the sensation seemed to have gone away. This morning I awoke with a slight sensation of loss of feeling in part of my left cheek. I did the same thing and I also put some cream on my face; apparently it went away. Later on, I felt some pain on the right mid side of my body. I'm pretty sure it's pain in my liver but I can't say 100%. I remembered to have experienced the same thing after my first dose and/or second dose. I'm still slightly in pain there as I write this. I'm sure all of this will go away very soon. Maybe a month ago, I had extreme severely dry skin on my hands. My skin was so dry that its texture was hard and it was about to crack (usually happens to me in the wintertime because I forget to hydrate my skin). I felt loss of feeling in my left hand where I had the extremely dry skin. This was very uncomfortable and worrying. It went away. I don't know if it's related, but I'm mentioning it in case. I will list below my three Covid-19 vaccines that I received. All of them were manufactured by Moderna. 02/15/2021 Lot no. 039K20A (full dose) Left arm, 03/15/2021 Lot no. 044A21A (full dose) Left arm, 01/20/2022 Lot no. 066H21A (booster/ half dose) Left arm. Thank you so much for your time and consideration! Have a great day!!!). I don't want to waste the CDC's time  I was conflicted about whether to send in this report or not, but as I'm in doubt, I don't want to miss saying something that could've been important. Thank you for your understanding. Best wishes. I am a U.S. citizen but I have an electronic signature from the EU because I had a student resident permit in Spain. It's the only verified electronic signature I have.