chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Never had a primary series at all and received 1 Bivalent dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Never had a primary series at all and received 1 Bivalent dose) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Never had a primary series at all and received 1 Bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Never had a primary series at all and received 1 Bivalent dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Never had a primary series at all and received 1 Bivalent dose).    No concomitant drug were reported.   The store administered a Moderna Bivalent booster dose yesterday to someone who has not completed a primary series. The patient never had a primary series at all and received 1 Bivalent dose.   No treatment drug were reported.
Baby gagged and forcefully vomited copious milk-like contents through mouth and nose. She was wiped and washed clean of emesis and wet diaper was changed (no diarrhea) over the next 10 min (face and trunk were almost completely covered with emesis), then appeared pale and sleepy/lethargic with pink blotchy swollen upper eyelids R>L. (She was responsive to voice but only briefly stirred and then seemed sleepy). No sz activity was observed before/during/right after emesis. She remained like this for 5-10 min without wheezing/resp distress/sz/apnea/cyanosis as we observed her.
used Sterile water as diluent for YF- VAX that was administered to a patient instead of using supplied diluent with no reported adverse event; Initial information received on 18-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who had used sterile water as diluent for yf- vax that was administered to a patient instead of using supplied diluent with no reported adverse event after receiving vaccine Yellow fever vaccine  [yf-vax].  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 yellow fever vaccine Solution for injection (strength, dose, expiration date and lot number not reported) via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event used sterile water as diluent for yf- vax that was administered to a patient instead of using supplied diluent with no reported adverse event (product preparation error) (unknown latency).  A Nurse called and reported that they used Sterile water as diluent for the YF- VAX that was administered to a patient instead of using the supplied diluent (0.6 ml single dose vial of Sodium Chloride Injection USP for single dose vial of vaccine). Caller wants to know if the YF-VAX that they administered was counted as valid and if they need to do a revaccination.  Lab data was not reported.  Action taken was not applicable.  Outcome: Unknown for the event used sterile water as diluent for yf- vax that was administered to a patient instead of using supplied diluent with no reported 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 the guidelines. 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.
Red rash on and around the injection site.  Rash appeared (or was first noticed) 8 days after the vaccination.  Flat, irregular shaped reddness.
Increase arm circumference 21.5cm, Redness, swelling, hot and hard to touch. Fever 100.2 Apply cold compress to area. RX: Benadryl 12.5mg/5ml, 1 tsp every 4-6 hours. Return to Clinic in 24 hours.
I felt like a had a mosquito bite on my back. Then it got irritated and started hurting so I went my doctor and was diagnosed with Shingles.
RED AND SWOLLEN ARM. PAINFUL TO TOUCH ARM. FEVER 102-103. IMMEDIATELY FOLLOWING IMMUNIZATION. 2 DAYS LATER FEVER STILL 102-103, SWOLLEN THROAT, CONGESTION, THROWING UP MUCUS, COUGHING, AND LARYNGITIS.  FEVER FINALLY WENT AWAY AFTER A WEEK.  SHE IS STILL CONGESTED AND COUGHING.
Immediate dizziness, followed by severe nausea, body aches, chills, high fever, fatigue, confusion, light-headed, the onset of which all began about 3 hours after the vaccination. Most symptoms lasted three full days.  One week after the vaccination and I still have confusion, dizziness, and vertigo like symptoms. If I look up or down or side to side too quickly, I feel extremely dizzy and nauseated. I can?t stand for more than about 5 minutes without feeling dizziness and nausea set in, even getting on my bike causes nausea and dizziness, driving, walking, anything related to movement. **Only had one vaccine - the form added a second set of boxes above and won?t let me remove it on this form.
Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL concerning a 15 year old female with attention deficit/hyperactivity disorder who denied she was pregnant on 06-MAY-2008 and was vaccinated IM with a first 0.5 mL dose of GARDASIL (lot # 659437/1266U).  Concomitant therapy on the same day included a dose of MENACTRA (Sanofi Pasteur).  Other medications included "STRAITERA", but has stopped taking this.  On 27-MAY-2008 the patient saw her family doctor and a pregnancy test confirmed the pregnancy.  On 09-JUN-2008, the patient was seen in the health department office stating she was pregnant and was enrolled in the WIC program.  The patient's LMP was reported to be 23-APR-2008.  Follow-up information was received from the registered nurse via a completed pregnancy questionnaire.  It was reported that the female patient had no concurrent medical conditions (also reported as unknown) and smoked 3 cigarettes per day when first pregnant.  The patient had no previous pregnancy.  On 09-JUN-2008 the patient stated that she was taking STRATTERA before pregnancy and did not take during pregnancy.  The medication used during this pregnancy was unknown.  The patient had some bleeding in early pregnancy.  On 08-OCT-2008 a baby girl was delivered prematurely at 26 weeks gestation in a hospital.  The baby weighed 1 pound and 11 ounces.  The length was 12 inches.  The head circumference was 21.5 inches.  The baby had congenital heart and breathing problems.  It was reported that the complication during labor/delivery, the diagnostic test during pregnancy and the infections or illnesses during pregnancy was unknown.  Upon internal review, born prematurely at 26 weeks and birth weight 1 pound and 11 ounces were considered to be other important medical events.  Additional information is not expected.
very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (very sore arm). At the time of the report, PAIN IN EXTREMITY (very sore arm) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported.   Treatment information was not provided.    This case was linked to MOD-2021-069878 (Patient Link).
vaccination following 1st shingles episode / got Shingles twice one episode followed the other / Suspected vaccination failure; vaccination following 1st shingles episode / got Shingles twice one episode followed the other; Covid; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had 1 episode prior to shingles vaccine).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: vaccination following 1st shingles episode / got Shingles twice one episode followed the other / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: vaccination following 1st shingles episode / got Shingles twice one episode followed the other) and covid-19 (Verbatim: Covid).  The outcome of the vaccination failure was unknown and the outcome of the shingles and covid-19 were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 02-Mar-2023 This case was reported by patient's friend via interactive digital media. The reporter informed that the patient got Shingles twice, one episode followed the other and then she got covid and reporter asked also twice. The reporter stated poor thing the patient had vaccination following 1st shingles episode and she had vaccination prior to 1st case of covid. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Chills and vomiting  only during first day after 2nd vaccine administration Lymph swelling in throat, laryngitis, headache, sinus swelling - lasted for 8 days Fatigue - lasted for 12 days
I had headache, slight fever, cough, nose, and lung congestion. I tested positive for COVID-19 at home. My brother was worried about my breathing getting too heavy, so I went to the emergency room. When I got there, they said everything was okay and sent me home. I still have a cough and congestion. The doctor prescribed me FLONASE and I was taking ADVIL.
Significant local reaction right upper lateral arm 10 x 10 cm erythematous plaque. 4 bullae 2 cm in length each.
4/24/19 she has the new Zoster vaccine and started with fever and body aches within a few hours after the shot.   That evening she also had symptoms of UTI she did a urine dip. She is a medical assistant trained for office work. Then she worked as an office manager. Took 5 days of cipro and that got better.   Within a few weeks of that she started getting pain in her L shoulder and arm that moves around (sometimes there are tender spots) seems to be worse with the full moon.   About 2 weeks after the zostavax she started with a swollen joint in her R index finger MCP joint and tendon and contracture of that R index finger. Now also in the third finger of her R hand for 1-2 weeks. Now feels like this process is starting in her L index finger as well the last 2 weeks(as of July 2019)      Mid June 2019 she did wake up one night and it felt like hot water was pouring down the inside of her R arm for a while. Awake several hours per night with the pain. Sometimes the pain in the shoulder, wrist or hand can be an ache or can be burning in character.   As of July 2019 her R hand has the trigger fingers. But her L  hand when she gets up in the am she cannot close it. Also can never make a fist anymore with that R hand. Somewhat cyclic symptoms as if it is changing with the cycles of the moon.   As of the date of this report she has had significant improvement in treating reactivated systemic bartonellosis believed to be reactivated by the vaccine
48 hrs post vaccination I experienced severe abdominal cramping, vomiting, diarreha for 8 hours. I haven't experienced influenza symptoms in decades prior.
Headache, Arthralgia,   HA occurs with head flexion 7/10. Starts at base of his neck and is a tightness sensation that moves to the top of his head. Motrin helping.   Narrative:    Other Relevant History:
Pt recvd Hep B (Recomb) & exp a reaction which pt did not specify; no further details were provided;
anaphylactic event; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic event) in an elderly 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (anaphylactic event) (seriousness criteria hospitalization and medically significant). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic event) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information was 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 was not applicable. Company comment: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.; Sender'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.
Very lightheaded while vaccine was injected into my arm.  It has never happened with other vaccines.  Once needle was pulled out of arm, was not lightheaded anymore. Also muscle in my arm is sore 1 month later and not getting better yet.
The symptoms were very much like a case of influenza without the respiratory component: moderate fever (~1.01), body aches, headaches, chills, etc.) lasting roughly three days.
No ADR,  timing ERROR, 2nd dose given 55 days after 1st Narrative: Timing ERROR only
No additional adverse events; The Medical Assistant reports the patient will receive the second dose on 12/12/2019.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, concurrent condition and drug reactions/allergies were not provided.     On 29-DEC-2016, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, route, lot # and expiration date were not provided) for prophylaxis. The patient would receive the second dose on 12-DEC-2019 (inappropriate schedule of product administration). No additional adverse events were reported.
Pt. states that after receiving the 2nd dose of Phizer 04/19/2021, started experiencing symptoms 06/01/2021 of abdominal pain (inflamed Uterus)(Leading to Hysterectomy), joint pain, double vision, throat pain (Aspirations), muscle pain, "brain fog", loose stool (Colonoscopy=Normal), anxiety, depression, and "suicidal-thoughts".
This spontaneous report as received from a physician refers to a female patient of unknown age, who on an unknown dates was vaccinated with the three 0.5 ml doses of GARDASIL (route and lot numbers not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that five to seven days later after received the first dose of GARDASIL the patient was slurring her speech, which the physician described as a "stroke like symptoms". This experience lasted for a day and then went away. The same thing happened after the patient was vaccinated with the second dose of GARDASIL. It was stated that the patient was given her third dose of GARDASIL but no adverse experience had been reported (the reported could not verify the patient's status). No treatment was given for the experience. At the time of the report the patient was recovered (also reported that the experience improved after stopping therapy). The patient sought unspecified medical attention. The relatedness for slurring her speech-stroke like symptoms was unknown for GARDASIL. Upon internal review stroke like symptoms was considered to be an other important medical event. Additional information has been requested.
Right after the vaccine, stomach, headache and I was tired. This was for about 8 hours. That was it for that. At 04:00 am, June 27th, I had a headache and this one lasted forever; it didn't stop even with Tylenol. It didn't come and go. I had a fever 99-101; I had body aches. I was very tired. Those a lasted a day. I did bedrest to treat.
diagnose with alpha-GAL syndrome after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of FOOD ALLERGY (diagnose with alpha-GAL syndrome after vaccination) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 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 FOOD ALLERGY (diagnose with alpha-GAL syndrome after vaccination). At the time of the report, FOOD ALLERGY (diagnose with alpha-GAL syndrome after vaccination) outcome was unknown.            No concomitant medications were reported Patient was wondererd about the origins of the cholesterol in the ingredients. No treatment medications were reported
first dose of Shingrix on 21-Oct-2019; shingles; rash/ rash is with no pain; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number 9DE73, expiry date 6th December 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. In June 2020, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for dose 2 of Shingrix. The reporter sataed taht, after vaccination with dose 1 of Shingrix, the patient expeienced rash and shingles in June 2020 and the rash was with no pain but wwas still present as shingles. Till the time of reporting, the patient did not receive dose of Shingrix, which led to incomplete course of vaccination. No further information provided. The reporter consented to follow up.
Experienced nausea starting about 15 hours after the injection.  Went home to rest.  Started feeling fatigue, then temperature went up.  At about 20 hours after injection, temperature peaked at 101 Fahrenheit.  When I woke up the next morning, at about 34 hours after injection, most of the symptoms had disappeared or lessened.  Three days later, I still occasionally experience mild nausea.
Redness/soreness, welt the size of a deck of cards at site of injection, itching.
Patient was wobbly/falling down and describing vision being "pixelated". Pupils were dilated and I was not able to find a steady pulse. He became sweaty and was complaining of extreme thirst. I had staff call 911 and gave 1 EPIPEN IM in left thigh and 50mg diphenhydramine in right thigh. Medics arrived and took over situation. Patient picked up by a friend about half hour later. Medics advised him to go to ER if symptoms returned.
Severe pain in arm.  Cannot move the arm.  Swelling of lymph nodes under that arm.  Chills, shakes, and diarrhea.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and unknown gender. The patients medical history and current conditions were not reported. On 17-JUL-2014 the patient was vaccinated with improperly stored M-M-R II (albumin status/therapy type: unknown) (dose/frequency, route of administration were not reported) (lot # J000202, expiry date: 19-JAN-2015). Concomitant medications were not reported. No adverse effects were reported. No product quality complaint (PQC) was reported for M-M-R II. The case is linked to 1407USA009063, 1407USA012208, 1407USA012207 and  1407USA012206 (same reporter link).Additional information has been requested.
Immediately after receiving vaccine, pt had a syncopal event with brief LOC. Caught by medical staff and lowered to the ground - placed supine with legs elevated. Pt quickly regained consciousness and was alert and oriented x3. Has a history of syncope with vaccines and medical procedures. Dad present. Vital signs obtained and noted to be WNL  HR 84 NSR Spo2 98% on room air B/P 123/61 laying down  118/62 sitting Pt hydrated with juice and was able to sit up and ambulate freely. Stayed for an additional 15 minute of observation without incident and left for home with dad.