chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child presented at worksite flu clinic for vaccination.  After watching dad receive flumist, parents wanted child to get flumist.  It was not noted until after it had been give that the child was under 2.
redness, swelling, and pain at the injection site. patient reported 2 days after vaccine was given.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A female patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration, on an unspecified date, at 0.5 ml single; MENACTRA, via an unspecified route of administration, on an unspecified date, at unspecified dose, and Hepatitis A, via an unspecified route of administration, on an unspecified date, at unspecified dose. Relevant medical history and concomitant medications were not reported. On 07Mar2016 the patient fainted with outcome of recovered the same day when she got up.
Moderna COVID - 19 Vaccine EUA fatigue, body aches, headache, nausa. These all started:( 1/4/20 started at 8:00PM starting to feelbetter today 1/6 8:45AM) strange dreams with hallucinations the night of 1/4/20 at 9:00PM - 1/5/20 4:00AM.
hospitalization, intermittent drooling, difficulty finding words (like a broca's aphasia), slurring of words, and absent seizure
This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 25-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # K010211, expiry date 17-JAN-2016; dose and route were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
HEART PAIN/ HEART RATE OF 180, BP OK, 2 HOURS LATER HEADACHE, MUSCLE ACHES, FEVER THROUGH THE NIGHT.
Sick; Very hard weakness; Very hard to sleep even with the pill; He cant walk because of weakness; A spontaneous report was received from a consumer concerning a 77-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events both are sick/illness, very hard weakness/asthenia, he could not walk because of the weakness/gait disturbance, very hard to sleep even with the pill/insomnia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 7 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the events both are sick, very hard weakness, he could not walk because of the weakness,he could not walk because of the weakness,very hard to sleep even with the pill.  Treatment details included trazadone.  Action taken with mRNA-1273 in response to the events was not reported.   On 11 Feb 2021 the outcome of events, both are sick, very hard weakness, he could not walk because of the weakness,very hard to sleep even with the pill was unknown.
1st dose 5 years ago, never got 2 doses; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose probably received 5 year ago.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt date: 23-JAN-2023 Reporter comment: The pharmacist stated that immunocompetent patient who probably received 5 year ago a Shingrix first dose. The patient never got 2 doses. however, patient was not sure about that first dose 5 year ago. The reporter did not consent to follow up Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Patient developed Papilledema and was hospitalized in critical condition for 6 days.  We still do not know the extent of effects that this vaccination has caused him.
Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: about 10 minutes after vaccine, patient alerted pharmacist that she feels tingling on her injection site and her left arm. After addtitional 15 minutes under observation, patient tingling condition is the same. vital signs : 97.5 BP 110/80 HR 73. Patient was adviced to monitor her condtion and seek medical help worsening. I called her today 3 times. patient did not answer phone.
On 02/20/2023, at about 03:00AM, I had extreme diarrhea and vomiting. I went to the doctor, they gave me a COVID-19 test, which was negative and they prescribed doxycycline. A couple of days later, they prescribed amoxicillin. I was getting dehydrated. I lost 5 or 6 pounds.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 16-OCT-2013, the patient was inadvertently administered ROTATEQ (lot # 0209AE, expiry date 28-SEP-2013) orally, that had expired on 28-SEP-2013. No adverse effects reported. Additional information has been requested.
pt husband reports that 10 days p/vax exp joint swelling of lt foot & lt hand;tx w/Ibuprofen & event resolved;pt subsequentl exp recurrent episodes of joint swelling which have been assoc w/viral infect (flu etc.);
A Week after first shot , pt's feet began to swell and became slowly impossible to walk. After 2nd VAX  side effects became worse and led to pt not being able to walk with assistance.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a pharmacist concerned a 68 year old White Not Hispanic or Latino male. 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, batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, frequency once total, administered on 10-MAR-2021 at left deltoid for prophylactic vaccination. No concomitant medications were reported. The pharmacist reported that the patient had a negative antibody test (coded as suspected immunological vaccine failure). It was not clear what antibody test the patient had. It was unknown what laboratory patient had antibody done through. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210507313- covid-19 vaccine ad26.cov2.s-suspected immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Post vax, the pt developed a fever of 102.5, then increased to 104.7. Motrin was given.
CHEST PAIN, ERYTHEMA, SWELLING AT INJECTION SITE Narrative: CHEST PAIN, "FLUID BUILD-UP" - "STILL RETAINING TOO MUCH FLUID",ARM ERYTHEMA/SWELLING AT INJECTION SITE; EMPLOYEE ISSED 1 DAY OF WORK; REPORTS A "HX REACTION WITH 1ST DOSE, WAS REQUIRED TO PROVIDE PHYSICIAN RELEASE PRIOR TO RECEIVING 2ND DOSE"; 1ST DOSE 12/29/20
Case reference number B0984326A was reported in a literature article and refers to a 4-month-old male subject who developed autoimmune haemolytic anaemia shortly after receiving his four-month immunisations including DTPa, Hib, rotavirus, pneumococcal conjugate and IPOL on an unspecified date (manufacturers, batch numbers, doses and injection sites unknown). No information has been provided on the subject's medical, family history or concurrent medication. A 4-month-old male subject was taken to a community hospital with a 2-day history of irritability, vomiting and dark stools shortly after receiving his 4-month immunisations including DTPa, Hib, rotavirus, pneumococcal conjugate and IPOL on an unspecified date (manufacturers, batch numbers, doses and injection sites unknown). No information has been provided on the clinical examination performed on the subject. Blood analysis revealed initial haemoglobin of 2.7 g/dL so he was transferred to an academic centre. Once there he had a weakly positive direct antiglobulin test with negative complement component 3 and immunoglobulin G. Further testing revealed immunoglobulin A mediated autoantibodies. Diagnosis was autoimmune vaccine-related haemolytic anaemia based on these results. Treatment consisted of oral corticosteroids. Outcome is improvement in his haemoglobin levels after treatment. The 6-month immunisations were given using a staggered approach that included serial full blood counts following each individual vaccine to monitor for evidence of haemolysis. Both IPOL and DTPa vaccines were given without incident; but his haemoglobin dropped to 7.0 g/dL and haemolysis was noted after the administration of the Hib vaccine. According to the authors this suggests that this vaccine was responsible for the initial episode so they plan to give him further Hib vaccine doses with steroid pre-treatment in the future. Author's conclusion: "We believe this case illustrates a novel method for not only confirming immunization associated AIHA but also isolating the causative vaccination".
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unknown dates, the patient had completed the 3-dose GARDASIL series and on an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (unknown route, strength and lot #). No adverse effects were reported. There was product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Pregnant and vaccinated; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and vaccinated) in a 39-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy from July 2015 to 01-Apr-2016. Previously administered products included for an unreported indication: TDAP on 18-Mar-2021. Concomitant products included SERTRALINE from 25-Jan-2021 to an unknown date, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), MAGNESIUM OXIDE and DOXYLAMINE SUCCINATE (UNISOM [DOXYLAMINE SUCCINATE]) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 03-May-2021. On 16-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and vaccinated). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PEPTIDES NOS at an unspecified dose and frequency. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and vaccinated) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient used Benadryl and Peptide as treatment medications. Patient had one previous pregnancy with pregnancy end date 01 Apr 2016.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Patient information is added; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 39-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Pt had red spots on left thigh but decreasing. Induration over 24 hours. Mom noted "red bump" 2/6/01 on left upper thigh. Increased in size during next 12 hours. Hot, firm to touch. No elevation in temperature. Full range of motion of both legs. Area showed improvement as of 2/11/01 with no residual sequellae.
3/21/2021 Developed urticaria. Treated at ER. Discharge to home 3/22/2021 Went to ER again for facial Swelling, diffuse body rash, itching,. External angioedema but no intrauval angioedema, treated for "likely allergic reaction." Given Pepcid, Prednisone, and Epipen. 3/24/2021 Telehealth visit with PCP office because not better.  3/26/2021 Seen at allergy office. Irregular heartbeat at that visit. Rash improving. 3/29/2021 Office visit with PCP. Rash resolved but continues to be itchy. Had bad headaches and nausea after each covid shot.
Receiving first dose of Shingrix in September of 2021 and having not yet received the second dose.; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's comment: The patient self-reported this case. The patient had not yet received the second dose.  The reporter did not consented to follow-up.  Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
The pt in question was looked up in system and it said she had only gotten one dose. This was confirmed with the staff who had a copy of her card only showing one primary Pfizer dose. She was a memory care patient and unable to confirm this information. We were told that her POC was the one who filled out the consent and signed her up. Her husband came in to the room shortly after the primary shot was given and reported that he had a separate picture of a vaccine card with two different doses on it including another primary dose. This happened in the room with the nurse and PHI that was sent to do the vaccine after confirming with staff this was the correct dose. The pt thus received the regular Pfizer adult as a booster instead of the bivalent booster.
1) On 12/11/2021 (One Day After the Vaccine): Pain under the armpit, left upper back pain, pain near collar bone.  I still have this pain, one month after taking the booster dose.  2) On 12/19/2021: Started getting hives and redness at different places of my body. This keeps coming and going. I am still having these hives.
No additional AEs or PQC reported; Caller reported vaccine administered after temperature excursions; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 29-JUL-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, lot #W038809 rHA , expiration date: 04-JUN-2024, administered intramuscularly for prophylaxis (strength was not provided).  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 18.3 degree fahrenheit for 1 hour and 5 minutes; no previous temperature excursions were reported.  No adverse symptoms were reported.
Swollen at injection site, Looks like a mosquito bite; Red at injection site, Looks like a mosquito bite; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen at injection site, Looks like a mosquito bite) and VACCINATION SITE ERYTHEMA (Red at injection site, Looks like a mosquito bite) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swollen at injection site, Looks like a mosquito bite) and VACCINATION SITE ERYTHEMA (Red at injection site, Looks like a mosquito bite). At the time of the report, VACCINATION SITE SWELLING (Swollen at injection site, Looks like a mosquito bite) and VACCINATION SITE ERYTHEMA (Red at injection site, Looks like a mosquito bite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Awakened during the night following the vaccine with chills, shakes, large bruise at site of injection, fever, weakness, tremor in right arm; slowly over a few weeks all symptoms except the tremor have resolved; The tremor continues as of submission date; Neurology consult has been ordered.
pt to hospital with c/o last 4 days increase in SOB, fever with chills, productive cough, lower extremity edema; found to be positive for COVID; given O2 supplementation, dexamethasone; condition worsened with increase O2 needs; placed on BiPAP; KUB showed possible ileus; pt experienced respiratory distress and was intubated with ventilator management; hypotensive, vasopressors given; ABX; suffered cardiac arrest; 15 mins of CPR; sustained A Fib rhythm with pulse but hypotensive; family decided to make her a DNR and transitioned to comfort care; pt expired on the ventilator
On 4/16-4/18 minor soreness and fatigue that temporarily disappeared. Then on 4/21, I experienced High Fever (103.8), Body aches, headache, extreme fatigue that lasted through Monday 4/26. Through that time I went and got a Covid test on Friday 4/23 and it came back negative. On Thursday 4/29, I started having pain on the right upper side of my abdomen. Friday evening, the pain grew even more intense which I could not lay down to sleep and no pain meds were taking it away. Saturday, 4/30 at 6 am ended up in ER at Facility. They were testing me for blood clots due to the chest pain and sever right side pain and the results showed no blood clots and my heart was fine. CT scan showed pneumonia, scarring in my lungs and a nodule growth on my lung. The doctor asked me if I was in the dessert recently if I had ever had valley fever. Valley Fever came back negative, another Covid 19 test came back negative. I completed taking 2 antibiotics and now on 5/25 (day 40) I am still feeling bouts of fatigue, wheezing in my lung and pain in my lung. I was healthy prior to getting the 2nd dose of Moderna and can't help but feel the vaccine triggered something in my system. Reporting this just in case it is an adverse effect from the vaccine.
I received my vaccine on 12/29/2020.  I work on contract for hospice.  I had no issues the day of the vaccine.  For the next 6 days I had no issues, problems, complaints, etc.  On 1/5, I noticed a raised, red warm rash that is 6 cm in diameter over the injection site.  It is non-tender.  No streaking or drainage.  I feel fine.  No fever.
Headache, Myalgia, NauseaVomiting, migraine headache
The patient did not have any adverse effects or symptoms after receiving this dose; Caller is a medical assistant who reports an 18-month-old patient received a dose of GARDASIL 9.; This spontaneous report has been received from a medical assistant concerning an 18-month-old patient with unknown gender.   The patient's concurrent conditions, medical history and concomitant therapies, drug reactions or allergies were not reported.  On 27-SEP-2022, the patient was vaccine with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter administered as prophylaxis, (lot number 1780878 which has been verified to be valid, expiration date reported and validated as 02-DEC-2023) (strength and vaccination scheme were not reported) (inappropriate age at vaccine administration). No additional adverse events were reported in the patient.
her hips and legs felt like they would give out; don't feel good; she felt kind of like how you do with the flu; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (her hips and legs felt like they would give out), FEELING ABNORMAL (don't feel good), INFLUENZA LIKE ILLNESS (she felt kind of like how you do with the flu) and MYALGIA (body aches) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Joint pain.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN (her hips and legs felt like they would give out), FEELING ABNORMAL (don't feel good), INFLUENZA LIKE ILLNESS (she felt kind of like how you do with the flu) and MYALGIA (body aches). The patient was treated with TRAMADOL for Back pain, at a dose of UNK dosage form and IBUPROFEN at a dose of UNK dosage form. At the time of the report, PAIN (her hips and legs felt like they would give out), FEELING ABNORMAL (don't feel good), INFLUENZA LIKE ILLNESS (she felt kind of like how you do with the flu) and MYALGIA (body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient gave consent to safety for Follow-up.
This spontaneous report as received from a physician via a company representative refers to a several patients of unknown age and gender. medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with PNEUMOVAX23. Dose, route reported, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The physician reported that in general, this office had seen several patients with negative responses to PNEUMOVAX23. The outcome of the adverse event was unknown. This is on of two reports from the same source (other case # 1407USA002434). Additional information has been requested.