chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the IPOL was no longer suitable for use after the excursion, but was administered to two patients post excursion with no reported adverse event; Initial information received on 18-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA287198(CLUSTER).  This case involves a 5 years old female patient and reporter reported that the Ipv (Vero) [Ipol] was no longer suitable for use after the excursion, but was administered to two patients post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (Wistar Ra 27/3), Varicella Zoster Vaccine Live (Oka/Merck) (Proquad) And Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Daptacel) For Immunisation.  On 12-Sep-2023, the patient received a dose 4 at a dose of 0.5 ml of suspect Ipv (Vero) Suspension for injection (strength: not reported, expiry date: 01-Jun-2024 and lot V1B891M) via intramuscular route in the left thigh as Immunization and was no longer suitable for use after the excursion, but was administered to two patients post excursion with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 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.
pain in arm; Injection site nerve damage; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced pain in arm and injection site nerve damage. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the injection site nerve damage was unknown.   It was unknown if the reporter considered the pain in arm and injection site nerve damage to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got Flu vaccine in October and reported that the arm still hurts. The patient reported that they told her that they hit a nerve. The patient stated that, she knew few people had the same problem and would never get that shot again. This case has been linked to US2019GSK105671, reported y the same reporter.
Pt was immunized with MENACTRA vaccine upon requesting meningitis vaccines for school. Pt received MENACTRA 3 yrs prior. Pt had form indicating pt needed TRUMENBA (Men B vaccine for school). No adverse effects have been reported to pharmacy by pt.
ACHEY; TIRED (EXHAUSTED); NO ENERGY; COULD NOT CATCH BREATH; FELT LIKE GOING TO PASS OUT (DIZZY); BLOOD CLOT IN LEG; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: unknown) dose was not reported, 1 total administered on right arm on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-APR-2021, the patient experienced severe pain and swelling in her right leg. On an unspecified date in APR-2021, the patient went to the emergency room and they did a lot of blood work and tests (results unspecified). The patient had ultrasound which revealed the diagnosed of blood clot in her right leg. The radiologist told her to use heat and elevate her leg and follow up with her primary care provider. The patient had an appointment with her doctor, who told her to come back in a week for a follow up ultrasound to make sure that the blood clot was gone. On 13-MAY-2021, she recognized the symptoms of another blood clot, so she used heat and elevated her leg again. On an unspecified date in MAY-2021 (reported as in mid to late May), the patient could not catch her breath and she felt like that she was going to pass out (dizzy). On an unspecified date, the patient experienced achy, tired (exhausted), and no energy. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clot in leg, could not catch breath, and felt like going to pass out (dizzy) on an unspecified date, and achey, tired (exhausted), and no energy on an unspecified date in MAY-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210654005-Covid-19 vaccine ad26.cov2.s-Blood clot in leg. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
One day after receiving ZOSTAVAX developed large area of reddness at injection site. Area tenderness swollen hot to touch. Pt feels nauseated and generally under the weather. 15 cm x 17 cm. No vesicles.
This is a spontaneous report received from a contactable reporter(s) (Other HCP). A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "DCIS", start date: 2009 (unspecified if ongoing), notes: HX of DCIS in 2009; "known allergies: PCN" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid-19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated for COVID-19 with Paxlovid orally from 03Aug2022 to 07Aug2022. It was unknown whether the patient had any other medications in 2 weeks. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on the information in the case, an association between the reported events Drug ineffective and Covid-19 and the suspect product bnt162b2 cannot be ruled out.
After the jab at 2:45pm, left shoulder started to feel numbing pain. After the jab I went back to my home office and worked, without any increase in activity. At around 5pm I started to feel very tired and at the same time, felt like my heart was racing, so I used my blood pressure monitor at 5:30pm to measure blood pressure and heart rate, and saw significant increase. Blood pressure peaked at 146/89 and pulse 79. I was tired, kept yawning, sleepy. I kept checking throughout the evening and the blood pressure dropped to 131/82 pulse 78 at about 10:25pm. This whole time, the left shoulder became increasingly achy and painful to the touch, with pain radiating from the injection point.  The next day was rough. General migraine and aches from the neck down to the hips, and severe muscle pains and muscle tightness in both shoulders and lower back.  I had to lay down most of the day and force myself to ice and stretch the muscles in shoulders and lower back to alleviate the pain.
Information has been received from a licensed practical nurse referring to multiple patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On unknown dates the patients were vaccinated with doses of improperly stored M-M-R II (lot # K021152 with expiration date of 02-NOV-2016; strength, dosage, frequency and route unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
The Patient was given FluBlok Quad at the IMZ event and she came back with a slight swelling and itching at the injection site. The Pharmacist had the patient place a Cold-pack at the injection site and had the patient take loratadine 10mg tab as she was still working and didn't want to go home. She was advised to come back to the pharmacy if the itching or swelling don't subside down
fever 103 8hr post inj;fever cont as of 27OCT95, 100.4;generalized body aches, productive cough (yellow mucous) & nausea;will be seen by MD today 28OCT95;
After 1st vaccine, 5 days after shot, noticed an itchy, light pink circular area below shot site. No rash, just itchy, about inch & half in diameter. Lasted 3 days, then went away. After 2nd vaccine which was given in same arm, the next day after shot, noticed the same itchy, light pink patches on upper arm, but several patches and bigger in diameter. Lasted 3 days. also with 2nd vaccine I had a low grade fever (101) the following day but was  the fever was gone that evening.
blanked out and fell; blanked out and fell; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left upper arm on 15Apr2021 16:38:53  (Batch/Lot Number: EW0158) (age at vaccination: 69-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history included asthma, coronary artery disease, blood cholesterol, Hay fever and diabetics. The patient's concomitant medications were not reported. The patient experienced blanked out and fell on 15Apr2021.  The patient got the vaccine on 15Apr2021 and they did it in her car and she waited 30 minutes and was fine. The caller was out and went into the bank and on the way out she did not know what happened. The caller got to where she went blank and fell on her face on the floor. She drove herself home. She got a daze and then she was down. The caller didn't get unconscious. The caller got up and didn't have to go to the hospital. This was within an hour of getting the vaccine. Caller states that she shrunk but was now 5 feet 3 inches. The caller mentions that she used to give injections for diabetics and as a rule they wiped the skin with alcohol before administering it. The lady administering the covid vaccine already had the vaccine into the syringe and the person administering it did not use alcohol. The vial with the rubber piece, the caller knows that they used to always wipe it off with alcohol and knock out the air bubbles in the vial. The caller is unsure if there were air bubbles in the syringe because she didn't see it being drawn up. This event was all outside in the car. Caller states they gave her a paper on the vaccine, it says they put some type of medication in the vaccine that has cholesterol in it. The outcome of the events was unknown.
(L) arm/leg "twitching" with uncontrolled movements. Unable to illicit on exam in office. No rotation tremor. Neurologically patient intact. Hand jerks to side spontaneously, patient has dropped items due to the twitching. The sxs have started improving.
Flu; chills; body aches; loss of appetite; Fever of 101; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.   This case involves a patient (age and gender unspecified) who experienced flu (influenza), fever 101 (pyrexia), chills, body aches (pain) and loss of appetite (decreased appetite), while patient received INFLUENZA VACCINE [Flu shot].   Medical history, medical treatment, vaccination, concomitant medication 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 not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) for 12 days, fever of 101 (pyrexia), chills, body aches (pain), loss of appetite (decreased appetite) (less than a week) following the administration of INFLUENZA VACCINE.  It was reported that, patient had not been exposed to anything else.   Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for events.  There will be no information available on the lot number for this case.
Headache, dizziness, joint pain of wrists and hands and arms. Joint pain lasted 24 hours. Headache and dizziness continue at time this report completed.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 24-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot number M033906, expiration date 20-JUL-2018 (dose, route and anatomical location were not reported) for prophylaxis. The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius(C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110.
THIS PATIENT WAS GIVEN 0.25ML MODERNA BOOSTER ON 11/20/2021.  ON 11/21/2021 AT ABOUT 11AM SHE EXPERIENCED SOME VISION CHANGES.  SHE WAS HAVING HALLUCINATIONS.  HER VISION WAS NOT BLURRY BUT RATHER SHE WAS SEEING THINGS THAT WERE NOT THERE.  THIS EVENT CLEARED IN SEVERAL HOURS.  ON THE EVENING OF 11/21/2021 ABOUT 7PM SHE STARTED TO EXPERIENCE SOME SWELLING UNDER THE INJECTION SITE, THE AREA BECAME RED AND HOT TO THE TOUCH.  UPON VISUAL INSPECTION, ON 11/24/2021 AT ABOUT NOON, I NOTICED THE REDNESS AND A HARDNESS TO THE SKIN.  THE AREA WAS ALSO VERY HOT TO THE TOUCH.  THE AFFECTED AREA WAS NOT AT THE INJECTION SITE BUT UNDERNEATH WHERE THE VACCINE WAS GIVEN.
Patient had blotchiness all over her arm near injection site.  Signs of pillowing near the injection site. Patient said it wasn't painful. It started the evening of the day of administration. When patient came back to report to us the next day she said symptoms were better than they were last night.
Urticaria-neck/chest/back/inner thighs (walk in visit 12/14/17) Bil arms. Redness and induration (R) deltoid injection site. Tx-Prednisone x3 days-OTC ALLEGRA, OTC BENADRYL.
Oral thrush treating with viscous lidocaine and nystatin swish and swallow Outcome not known yet
Six days post-vaccination, patient experienced nausea and extreme dizziness in the morning.  She was not able to get out of bed.  She had elevated blood pressure and rapid heart rate.  A visit was done with her primary care and meclizine 12.5 mg was prescribed.  The physician suggested for her to take an addition tablet of amlodipine 2.5 mg if her BP stays elevated.  Luckily the patient?s BP returned to normal in the evening.  The patient continue to experience dizziness for 1 month and felt normal afterward.
Extreme pain in left arm where injected - after 2 weeks still pain - stiffness up in my neck.
Immediately after, I just had some chest tightness and pain but I did not receive treatment for it. It was chest pain and I was breastfeeding at the time. It resolved on its own after two days. The most recent, I had a lot of sinus pressure. I had a cough. It was more of a congested kind of cough (wet). I had headache and fatigue. I did see the doctor for it. I was on a Z-pack for a week. The symptoms did not resolved. I was prescribed a stronger antibiotic and then it resolved. It all lasted a month before I got better and the symptoms resolved. I did not have COVID test. Telehealth visit.
On 09/12/2000 the patient developed a severe case of chicken pox that was described as a "classic" case of chickenpox. The patient had pox all over her body as well as in her throat and mouth. The patient required an ER or physician visit. On 09/20/2000 te patient recovered. No further information was provided.
Pt recvd measles vax on 23AUG91 & on 6SEP91 pt exp chills, diaphoresis, arthralgia & a rash on trunk & low grade temp;
there are bumps on the roof of my mouth; it feels like when I eat something hard or too hot; slight white, small dots; This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISORDER (there are bumps on the roof of my mouth), EATING DISORDER (it feels like when I eat something hard or too hot) and APHTHOUS ULCER (slight white, small dots) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ORAL DISORDER (there are bumps on the roof of my mouth), EATING DISORDER (it feels like when I eat something hard or too hot) and APHTHOUS ULCER (slight white, small dots). At the time of the report, ORAL DISORDER (there are bumps on the roof of my mouth), EATING DISORDER (it feels like when I eat something hard or too hot) and APHTHOUS ULCER (slight white, small dots) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was provided
I had chest tightness, difficult to get a full breath for one week following the first dose of Pfizer.  It felt like physical anxiety symptoms, however it began the day after the first shot and lasted one week following that first shot.  Symptoms were on and off yet happened every day.  Felt similar to panic attacks, which I have not had in years.  I had no issues after the second dose other than normal immune response.  The chest tightness and difficulty getting a full breath only happened after the first dose.  I am very familiar with what anxiety feels like, this was similar, yet different enough that I thought it was worth reporting in case others are experiencing it.  I was concerned and it did interfere with my daily life for a week after the first dose.  I did not report it to my doctor.  I recovered after a week.
0n 9/24/11 at 3:30 AM employee states she awakened with c/o nausea, no vomiting, stomach cramps & had episode of diarrhea at that time. States throughout the day on 9/24/11 she had approx 5 episodes of diarrhea, no vomiting, (+) abdominal cramping. No diarrhea on 9/25/11, states she has "some" abd cramping with no diarrhea. States no fever, no fatigue, no H/A. States she has been taking PEPTO BISMOL on 9/24, 9/25, 9/26.
Pt had body aches after the vaccine and had fever for the next 48 hours. However, today Pt started to have chest pain and pressure with breathing difficulty when she walks. Pt. denied fever. Pt was advised to go to ER due chest pain and shortness of breath.
2 weeks following the 3rd Moderna I developed some pruritis. That night I woke up with severe heart burn and hives throughout my body. I was seen at an urgent care and started taking 20 mg of pepcid twice daily, 20 mg of zyrtec twice daily and benadryl for breakthrough. I also took Omeprazole for 1 week.  The heartburn resolved, but the hives continued and did not resolve. I had tried different antihistamines. Eventually I was seen by an allergist who diagnosed me with chronic spontaneous urticaria. Currently I am taking zyrtec 20 mg twice daily, pepcid 20 mg twice daily, and singulair 10 mg. the hives have persisted.
Pt recv vax on 6/3/98; 1/2 hr later pt exp redness &swelling of injection site; crying for +3hrs; tx=acetaminophen.
Approximately 27 hours after vaccine began experiencing sudden lower back pain, fatigue and migraines that wrapped from the front of head to the back of skull. These symptoms continued for the next three days and swollen lymph nodes in left armpit and pain in neck also occurred within two days of vaccine.  It is now four days post second dose and headaches remain. Ibuprofen taken throughout these four days in order to remain functional.
Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves an unknown age patient who past the day seven dose and now he is at two weeks, while he/she supposed to received vaccine IMOVAX RABIES on an unknown date via unknown route in unknown site of administration. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to missed dose. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. Follow up 28-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. No additional information received. List of documents held by sender: none.