chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was ordered to get meningococcal on 8/14/09 and nurse gave pneumococcal.
No adverse effects the first shot, second shot I had a light headache later that same day, and a low fever the next day of 99.5, but generally felt good overall.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: heart palpitations-Severe
Patient received first vaccine on 3/24/2021 received second vaccine on 4/9/21.  Patient had sore arm, body aches, fever, and chills.
Information has been received on 09-MAR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated by a physician for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
On my first shot, I noticed my urine color changed. It's red orange color. It last for few days and I felt a mild cramps on my upper abdomen. I ignore it because I thought it's from my Turmeric tea. After a week of my 1st shot  I went to the doctor because of fast and very high heart rate. On my 2nd dose (11/05/21) It happened again and this time I didn't have my Turmeric tea and my urine is red orange and sometimes it looks like my urine color mixed with blood. It's darker than my first dose. I am experiencing mild pain on my abdomen on and off.  I want to include also that after my first dose my period is very painful. I think it's because of the vaccine. Until now I still have the symptoms of the fast heart rate and currently taking the medication I listed.
Equivocal titer for rubella; had a previous unspecified reaction to the measles vaccine; This spontaneous report was received from a nurse concerning to a currently 18-year-old non-pregnant female patient. The patient's concurrent conditions included hereditary serositis and acquired asplenia (reported as aspenia). Drug reactions/allergies included unspecified reaction to measles virus vaccine live (unspecified), meningococcal B rfHbp vaccine (E. coli) (TRUMENBA) vaccine, and influenza virus vaccine (unspecified) (reported as flu vaccine). Concomitant medications were not provided.  On an unspecified date in 2003, she was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dosage regimen, lot# and expiration date were not provided), administered subcutaneous. Indication was reported as "needed rubella booster for college".  On an unknown date, the patient went because she "needed a booster of rubeola vaccine (unknown) for an equivocal titer" (rubella antibody negative), and it was reported that she had an unspecified reaction to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (vaccination complication) when she was vaccinated (on an unspecified date in 2003). The outcome of the events of vaccination complication and rubella antibody negative was not reported.        The causal relationship between the event of rubella antibody to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
Information has been received from a consumer, for the Pregnancy Registry for GARDASIL, concerning her 15 year old daughter with seasonal allergy who on 22-OCT-2008, on 29-DEC-2008 and on 22-APR-2009 was vaccinated with a first, second and third dose respectively, of GARDASIL (routes and lot numbers not reported). Concomitant medication were unspecified. The mother reported that on 1-MAY-2009, the patient conducted a home urine pregnancy test and it came up positive. The patient went to see her physician and the physician conducted a urine pregnancy test and the result came back positive again (LMP: 26-MAR-2009, EDD: 31-DEC-2009). The mother added the patient mentioned that after receiving the second and third dose of GARDASIL, the patient experienced soreness on the injection sight. Also the mother reported the patient is fine now. The patient sought medical attention at the physician's office. No further information provide. Additional information has been requested.
A report has been received from a Health Professional concerning an 11 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The patient was administered into eye on 22-Oct-2013. The outcome of the event of ADMINISTRATION INTO EYE is unknown. The report was considered to be non-serious.
I felt nauseated right after my J&J vaccine. I also have dry heaviness. I also experienced flu like symptoms. My chin also swelled up really big and I had hard time breathing. I went to the ER due to my throat swelling up and my difficulty to breathe for three days straight and also felt a pressure sensation in my throat and chest.  At the ER they performed lab work, gave me a Toradol injection and also gave me steroids. I also took a homeopathic remedy which was given to me by a friend who is a doctor and my symptoms started to get better.   On another note, my sister also had the J&J vaccine and she also had nausea symptoms but only lasted 3-4 days but I do not know if this is a genetic component.
VACCINE WAS GIVEN OUT OF A MULTI-DOSE VIAL AFTER EXP DATE. (30 DAYS FROM PUNCTURE OF ANTHRAX VIAL)
Red elliptical "rash" around injection site--4 inches long, 3 inches wide, itchy and very slightly painful. Appeared 9 days after 1st dose of vaccine.
4 days after administration, nickel size redness. On 5th day after; hive looking rash appears. On 6th day after administered vaccine entire deltoid reddened, hard and hot. Went to Emergency Dept; dx with infection per physician.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 20-NOV-2017, the patient received inadvertently a dose of ZOSTAVAX non-valid Lot #M038864, expiration date on 12-DEC-2017, for prophylaxis (strength was not reported) that was administered intramuscularly instead of subcutaneously. The vaccine was administered with a sterile diluent (MERCK STERILE DILUENT) Lot #M046369, expiration date on 07-JUL-2019 (strength was not reported). No adverse effects were reported.
Pain at the site where had shingles; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles last year in 2021).   In September 2022, the patient received Shingles vaccine. In September 2022, less than a week after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-SEP-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter was a consumer who had stated he/she was experiencing pain at the site where had shingles last year, following shot this week. Additional supportive information: Follow-up would not possible, as no contact, details were available.
Blinding headache left side, moving to pain in temple, left eye watering, jaw pain, pain swallowing.
No adverse event; 4 patients received expired Moderna Bivalent Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients received expired Moderna Bivalent Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 044H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients received expired Moderna Bivalent Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients received expired Moderna Bivalent Covid-19 vaccine) 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 EXPIRED PRODUCT ADMINISTERED (4 patients received expired Moderna Bivalent Covid-19 vaccine).    No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732790, US-MODERNATX, INC.-MOD-2023-732792, US-MODERNATX, INC.-MOD-2023-733320, US-MODERNATX, INC.-MOD-2023-733325, US-MODERNATX, INC.-MOD-2023-733328 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732790:Monovalent dose patient 5 US-MODERNATX, INC.-MOD-2023-732792:Bivalent dose patient 5 US-MODERNATX, INC.-MOD-2023-733328:Patient 2 US-MODERNATX, INC.-MOD-2023-733325:Patient 3 US-MODERNATX, INC.-MOD-2023-733320:Patient 4
Woke up with acute, irrational panic attack in the middle of the night. No previous history of panic attacks, no anxiety about receiving injection, not particularly stressful day.
Patient called to report severe arm pain in left arm where shot was given radiating up to the shoulder.  She reported having no energy and a fever.  She also said she had a cough and some shortness of breath, or struggling to breathe.
IMMUNIZATION CLINIC IS OPERATED IN THE MAIN HOSPITAL. PT WAS ADMINISTERED ANTHRAX VACCINATION IN L DELTOID AND AS ANOTHER VACCINE WAS BEING PREPARED (NOT ADMINISTERED) PT BECAME PRE-SYNCOPAL. PT WAS LOWERED TO FLOOR AND, ALTHOUGH SLOW TO RESPOND INITIALLY, WAS ALERT AND ORIENTED x 3 UPON BEING PLACED SUPINE. PT WAS KEPT SUPINE UNTIL EMERGENCY ROOM PERSONNEL ARRIVED ON SCENE. PT'S VITAL SIGNS IMMEDIATELY FOLLOWING EPISODE WERE AS FOLLOWS: BP 120/71, SPO2 98% RA, HR INITIALLY 41 IMPROVED TO 63 WITHIN 3-5 MINUTES. PT DENIED ANY COMPLAINT AND ADMITTED AFTERWARD THAT HE HAS HAD EPISODES OF SYNCOPE/PRE-SYNCOPE UPON RECEIVING VACCINES IN THE PAST, THE LAST EPISODE BEING APPROX 10 YEARS AGO. PT DID NOT ADMIT THIS HISTORY DURING INTERVIEW PRIOR TO VACCINATION. PT IS CURRENTLY BEING EVALUATED IN THE EMERGENCY ROOM.
Information has been received from a physician concerning a 12 year old male who on 27-FEB-1996 was vaccinated with a 0.5mL dose of varicella virus vaccine live (Oka/Merck) (Lot# 610247/0445B) in the right arm. "4 days ago," on 27-APR-2007, the patient developed "breakthrough greater than 250 lesions and fever after receiving varicella virus vaccine live (Oka/Merck)." The patient sought medical attention at the doctor's office. The outcome is unknown. No further information was provided. No product quality complaint was involved. Additional information has been requested.
2nd and 3rd day, severe muscular pain, headaches, fatigue, pain in right arm 3rd day, onset of acute hypertension, headaches, noise in ears.  Average BP 175/125, pressures up to 251/155.   Clonidine 0.1 mg once / twice daily is holding BP at 145/96
Patient received a second bivalent COVID vaccine in error.  The first bivalent COVID vaccine was administered on 9/7/2022. The patient believed that a second vaccine was needed after 3 months according to "what she hears on the news". When the patient came in on 1/9/23, we checked our state vaccine database to see if she was due for the bivalent COVID vaccine. The vaccine that was administered on 9/7/22 never actually was reported to our state database (we use automatic reporting from our company's immunization vaccine portal directly to Immunization Registry, but it did not work correctly), so we administered another bivalent COVID on 1/9/23. The patient called the pharmacy on 1/19/23 wondering when another family member could get a second bivalent vaccine, which is when we became aware of the error. She has reported no adverse side effects as of now.
less than 10 minutes after vaccine administration patient was kneeled over on floor bent over on chair . extremely pale, feeling lightheaded, head pounding, ears with sudden onset of lots of pressure. mother said never reacted to vaccine like this before. called EMTs they said her blood pressure was fairly low and wanted to take her to the ambulance for further evaluation.
Pt. with syncopal episode 5 min after vaccinations. LOC less than 5 seconds then awake, drinking juice & left office ambulatory with mom.
A LUMP IN ARM OF  VACCINATION; PAIN IN ARM OF VACCINATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced a lump in arm of vaccination. On APR-2021, the subject experienced pain in arm of vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a lump in arm of vaccination and pain in arm of vaccination was not reported. This report was non-serious.
Child had Varicella and DTaP on 3/27/03.  On 4/10/03 mother noticed a fine rash behind ears on neck and trunk.  Child was irritable and rash lasted 4-5 days.  No fever present with this episode.
About 10 minutes after shot was taken I got a sharp pain in my stomach and felt like I had to throw up, about the same time I was sweating profusely and felt like fainting,  they brought the wheel chair over to me and was going to move me, but the symptoms were improving and I started to feel better, I have never had symptoms appear that fast, very scary stuff for sure.
A non-serious spontaneous report of a pregnant woman received a dose of H1N1 LAIV was received from a registered nurse/health professional concerning a 32-year-old female. The patient's medical history included anemia and back pain and obstetrical history included gravida three, para three and LMP date was 03-Jun-2009. The gestation period was 24-weeks and expected date of delivery was 10-Mar-2010. The concomitant medications taken by patient were iron tablets (oral, twice daily) and prenatal vitamins (oral, once daily). The patient was not ill at time of vaccination and no other vaccinations were given within 4 weeks of the H1N1. On 18-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. The patient delivered a female child on 18-Mar-2010. It was full term vaginal delivery with no medical complications. The newborn had a weight of 6lbs 12 oz, length of 19.5 inches and head circumference of 13 inches. The fetus had no complications with delivery. There was no adverse event associated with this pregnancy therefore, treatment and reporter causality assessments were not applicable, and the event vaccine exposure during pregnancy was considered resolved. Additional information was received on 05-Jan-2010 and incorporated into the narrative: past medical history, gestation period, EDD, LMP, gravida and para and concomitant medication. Additional information was received on 28-Apr-2010 and incorporated into the narrative: pregnancy outcome, medical history and neonatal information. Other information received was primary care physician details and patient details.
Initial unsolicited report received from a consumer on 23 October 2015. This case involves a female patient (age was not provided) who was vaccinated with a dose of INFLUENZA VACCINE (Flu Vaccine) (Batch number, dose, dose in series, route and site of administration were not reported) (not sure if it was FLUZONE) in the last year on an unspecified date. The patient illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Concomitant medications were not provided. On an unspecified date, following the vaccination, the patient experienced arm pain and stiffness. Relevant diagnostic tests and corrective treatments were not reported. The patient's outcome was reported as unknown. List of documents held by sender: none.
Soreness in arm at injection site. Initial shot was very painful. Took pain meds.
9:00pm after vaccination: chills, sweats, fever, severe body aches, fatigue (continued to sweat profusely all night); 7:00am next day: fever of 101-102, chills, sweats, fatigue, severe body aches (painful to breathe/chew/walk), nausea, headache (no swelling or redness at injection site); 12:00pm next day: fever and aches reduced using Advil (400mg); 9:00pm next day: mild headache next morning: all symptoms gone.
This spontaneous report has been received from a nurse prescriber referring to an unknown number of patients. Information regarding the patients' current conditions, medical history, concomitant therapies and drug reactions or allergies was not provided. On 15-MAY-2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB with lot number: N002202 and expiration date: 04-NOV-2019 (dose, anatomical location and route were not provided). The RECOMBIVAX HB doses were exposured to a temperature ranges between 32° (F) fahrenheit and 35 °F, during a time frame of 2 hours which were called by a data logger, then returned back in range. There were not previous temperature excursions. No adverse effects were reported. This is one of several cases from  the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA009811: US-009507513-1705USA009812: US-009507513-1705USA009810:
J96.00 ACUTE RESPIRATORY FAILURE 5/3/2023 PNEUMONIA J96.00 ACUTE RESPIRATORY FAILURE 5/3/2023 ACUTE RESPIRATORY FAILURE
started on Oct. Symptoms 31, 2020. Headache, stomachache, fever, chills, muscle aches. Confined to bed and couch. Couldn't do anything. Lasted 2 days. Then the tingling started close to my wrist on the inside of right , then left arms. The irritation had me rubbing and looking for something on my arms. On November 3 or 4 a rash broke out on both arms close to my wrists. It was in a line almost in a circle around both arms. I had no redness, pain or swelling at my injection site. The rash itched, burned and was painful. It reminded me of poison ivy. Raised fluid filled bumps with red skin. I called my doctors office. They did not want me to come in. They did not want to see the rash. I must have been exposed to or come in contact with something. Take some XYZAL allergy pills for 3 days. I used calamine lotion. Worked well. Rash, itch and burn lasted till the middle of December. Used Benadryl the last 2 weeks to help with itch.  January 3, my left eye was red. By January 5 my pupal was small and i was so sensitive to light only complete darkness helped with the pain. Optimist said I had iritis. This can be caused by shingles, i read. Prednisolone AC 1% and Atropine 1% were prescribed.
Prolonged H/A for 3 days.  H/A did resolve by day #4.
PSORIASIS FLARE UP IN "ODD PLACES" 8 TO 10 HOURS AFTER MODERNA INJECTION.
No additional AEs; Caller reported expired dose of PROQUAD was administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age or gender. Information of concurrent conditions, pertinent medical history, concomitant medications and drug reactions/allergies was not reported.  On 03-MAR-2023, the patient was administered with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant Human albumin (rHA)) (PROQUAD) injection (0.5 milliliter (ml), lot# U026797, expiration date 26-FEB-2023, strength was unknown) intramuscularly (IM) at right thigh for prophylaxis (expired product administered). No other information provided. No additional adverse events (AEs) (no adverse event) or PQC reported .
It's been long time ago for the first dose / But It should be 2 years from now; 2 after short feels like got flu; had fever (body temperature was 38°C),; This case was reported by a consumer via sales rep and described the occurrence of influenza like illness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 21st May 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 22nd May 2018, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza like illness and fever. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the influenza like illness and fever were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the influenza like illness and fever to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's husband. The age at vaccination was not reported. Next day and day 2 after short feels like got flu, had fever (body temperature was 38 degree C), day3 and day 4 getting better and day 5 back to normal. Till the time of reporting patient did not receive the 2nd dose, which led to incomplete course of vaccination.      Lab Comments: on an unknown date body temperature was recorded
Information has been received from a registered nurse concerning a 20 year old female patient who on 30-MAR-2007 was vaccinated with a first 0.5ml dose of GARDASIL (Lot# 657006/0188U). On 30-MAR-2007 the patient experienced a severe headache. The patient went to the ER but it was not known if she was admitted. On an unspecified date, the patient recovered. On the morning of 21-MAY-2007 the patient received a second dose of the vaccine (Lot#657737/0522U) and no experience was reported. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/14/2007. Information has been received from a registered nurse concerning a 20 year old female student with a history of migraine, asthma and allergies to acetaminophen, codeine, hydrocodone, sulfa, and VICODIN who on 20-MAR-2007, was vaccinated with a first dose 0.5ml dose of GARDASIL (lOT# 657006/0188u). On 20-MAR-2007 the patient experienced a severe headache. The patient went to the ER the day after receiving her vaccination. She reported feeling unclear during the injection and developed a diffuse headache, worse than a migraine and not relieved with MOTRIN or TORADOL. Laboratory diagnostic studies performed were a neurological exam and a CT scan which were both reported to be normal. The headache improved with DILAUDID. The patient was discharged with instructions to follow up with her primary care physician to continue GARDASIL series. Within on to two days, the patient recovered. On the morning of 21-MAY-2007, the patient received a second dose of the vaccine (Lot#657737/0522U) and no experience was reported. No product quality complaint was involved. It was reported that the patient's headache was most likely a side effect from the vaccine. Additional information is not expected.