chrisvoncsefalvay/vaers-outcomes huggingface dataset:
June 18, 2012 To VAERS My son was given his one year old shots on his birthday on Thursday, May 31, 2012 at his regular Clinic. Two days after his shot, my baby started crying and his body was full of rashes. He has been itching his eyes and head continually. He has lost his appetite dramatically, but would still drink his milk. We took him to Clinic and the Doctor ordered that blood sample should be taken for allergic reactions. That was done at hospital. The result was negative. The Shots that were allegedly administered by Clinic on May 31st, 2012 were, DTaP, 4th shot, Haemophilus Influenzae type b (hib), Hepatitis A, Pneumoccocal vaccines. My child still has the side effects 18 days later, Sunday, June 17th, 2012. We are worried and do not know what to do. No treatment has followed this reaction. Only 0.2% hydrocortisone was prescribed by the nurse at clinic and by Hospital emergency Doctor to help him with the itching. Though it has, the adverse symptoms are still there. Please contact us at your earliest convenience by phone or the email provided below. Your cooperation means a lot to us. Last time we wanted to visit all the medical providers the doctor referred us to before we reported the adverse symptom to VAERS. Today, it is June 28, 2012. Almost a month from the date his shots were administered. At this point, we decided to report to VAERS, because none of the medical providers have found out what the problem is, we are reaching to a point where we have no medical provider to go to. We have also visited a dermatologist who verbally told us that it is probably a virus or of that sort, may or may not be the shots, but skin needed treatment. He later found out patient's insurance was not active that day, and sent us home without legally diagnosing patient's problems, or without prescribing medicine. The rashes on my son's body have decreased, however his face is still full of it and he still has decreased appetite. Patient rarely cried the first year of his life. He now cries daily, hourly, and by the minute. He rolls over his bed again and again. We don't know what he is trying to tell us. Getting worried is a daily hobby for us now. After visiting hospital emergency twice, his regular Clinic three times, a dermatologist, and not to forget, an allergy doctor, we are finally giving up. We don't know what to do.
Paralysis started in right arm. Rush to emergency room. By which time I was unconscious.
Pt came in 7/31/06 for vaccines tolerated well. Pt came in today 8/2/06 with red area (size of baseball), warm to touch/tender on Lt arm. Guardian states 5x, started 8/1/06 and worsening. Dr order warm compresses and Benadryl for tx and to f/up if sx persist.
Soreness at site of injections; muscle aches; swollen lymph node; sore throat; This is a spontaneous report from a contactable consumer (patient). A 52-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number was not reported) via an unspecified route of administration on 05Mar2021 at 14:45 (at the age of 52-years-old) in the left arm as second dose, single for covid-19 immunization. The patient medical history included asthma and had known allergies with PEN. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN), via an unspecified route on 14Feb2021 at 15:30 as 1st dose, single dose for COVID-19 immunization. The patient concomitant medications included lifitegrast (XIIDRA) and cannabidiol (CBD OIL). On 05Mar2021 at 22:00, the patient experienced soreness at site of injections, muscle aches, swollen lymph node and sore throat. The patient did not received treatment for events. The outcome of the events was not resolved.  No follow up attempts are possible. Information about lot/batch number cannot been obtained.
This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a adult male patient who received SHINGRIX. In April 2018, the patient received SHINGRIX. In April 2018, less than a month after receiving SHINGRIX, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was unknown. The reporter considered the erythema of extremities to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller's husband received the SHINGRIX vaccine a few days ago and developed a red mark about 2 to 3 inches in diameter on his arm.
Information has been received from a pharmacist concerning a female who on 05-MAY-2009 was vaccinated intramuscularly with a dose of PNEUMOVAX (it was not know if this was the patient's first or second dose). Within one hour of receiving the dose the patient's arm began to swell. It had progressed with redness and warmth to touch. The patient's arm's swell and redness and warmth to touch persisted. The patient went to hospital to  be evaluated (not reported if the patient was admitted). Additional information has been requested. Additional information has been requested.
Adverse reaction; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Concurrent medical conditions included alcohol allergy (allergic to alcohol ).   On an unknown date, the patient received Boostrix at an unknown dose and Twinrix at an unknown dose. On an unknown date, unknown after receiving Boostrix and Twinrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Boostrix and Twinrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was allergic to alcohol. On the same day the patient received Boostrix and Twinrix and experienced an adverse reaction, did not know exactly the nature of the reaction. The reporter did not consent to follow up.
Flu symptoms , fever ,chills, migraine. Vomiting, nausea .
The patient received the Janssen vaccine but was under 18 years old. The patient was 17 years old at the time of administration.
Mother states that approximately 3 hours after immunization, infant began screaming and continued to do so for 3 hours. No able to console or comfort child in any way. No fever. Immunization given 4/23/03.
I21.4 ACUTE NON ST ELEVATION MI 4/29/2023 ACUTE PERICARDITIS, UNSPECIFIED I30.9 ACUTE PERICARDITIS, UNSPECIFIED 4/29/2023 ACUTE PERICARDITIS, UNSPECIFIED I51.4 MYOCARDITIS 5/2/2023 ACUTE PERICARDITIS, UNSPECIFIED
Information has been received from a physician concerning a 9 week old male who on 13-FEB-2007 was vaccinated with an oral first dose of Rotateq. Concomitant vaccination administered that day included a dose of Recombivax HB and a dose of Prevnar. On 19-FEB-2007 the patient developed perfuse bluish hives ranging from the torso and legs, spreading to face and arms. On 20-FEB-2007 the patient had a low grade fever (temperature unspecified). When the physician saw him on 21-FEB-2007, she noted that hives had reduced to just a few. The patient was considered to be recovering. There was no product quality complaint involved. Additional information has been requested.
MSK pain surrounding injection site rated 7/10 since administration of vaccine. Had not subsided and still persisting x 1 month after vaccine injection.
This initial spontaneous case, was received on 03-Oct-2017, from other health professional and concerning a 24-year-2017, adult, female patient. The patient had no relevant medical history. On 03-Oct 2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195124, expiry date: Apr-2018: not reported). On the same day, at night after vaccination, the patient had experienced injection site redness swollen, hard, pain and hot to the touch. The patient also had symptoms of sore and hot at that area. The patient also had cough. On 09-Oct-2017, the patient was recovered from the events. The reporter assessed this case as non-serious. Follow up received from the reporter on 16-Oct-2017: The patient's route of administration and anatomical location were updated. Narrative amended accordingly. Follow up received from health care professional on 25-Oct-2017: The outcome of the events was changed from not recovered to recovered. Significant case correction received 03-Oct-2017: The event 'sensation of heat' was deleted. The verbatim (description as reported) for 'injection site warmth' was corrected to 'Described injection site as [red, swollen, hard, painful and] hot to the touch'. The event coding for the verbatim 'Patient described injection site as [red,] swollen,] hard[, painful and hot to the touch] was correct from 'injection site lump' to 'injection site induration' and labeling was corrected accordingly. The listedness of the event 'cough' was corrected. The listedness of the event 'injection site swelling' was corrected.
Patient received their first series of Covid Vaccine with Pfizer. The booster dose given was Moderna. Patient is not of age to received the Moderna booster.
This spontaneous report as received from a healthcare worker, referring to patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 13-MAR-2017, the patient was vaccinated with improperly stored dose VARIVAX which had Lot number  M033905 with expiry date on 20-JUL-2018 (strength and route were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccine was exposed to a temperature as follows: >14 Fahrenheit grade but < 46 Fahrenheit grade for 40 minutes; >14 Fahrenheit grade but < 46 Fahrenheit grade for 40 minutes; >14 Fahrenheit grade but < 46 Fahrenheit grade for 50 minutes and had a previous excursion recorded by a data logger of >14 Fahrenheit grade but < 46 Fahrenheit grade for "5.3 hours" and >14 Fahrenheit grade but < 46 Fahrenheit grade for 50 minutes. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA008242: US-009507513-1703USA008243: US-009507513-1703USA008236.
About 5 to 10 minutes after my shot I started to feel flushed and warm, a tingling sensation all over, dizziness and lightheadedness. It came over almost like a wave and passed after about a minute. I did not report it at the clinic initially because it passed so quickly and caught me off guard. I stayed for 20 minutes and then left to go home. I started having these same symptoms listed above, which would come and go in waves about 30 minutes after the vaccine. I took 25mg of benadryl and 20mg of famodidine and symptoms completely resolved.
patient says that she was in bed for about a day after each Moderna Covid-19 vaccine; sore injection site arm; felt tired after receiving each Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (patient says that she was in bed for about a day after each Moderna Covid-19 vaccine), VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (felt tired after receiving each Moderna Covid-19 vaccine) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (patient says that she was in bed for about a day after each Moderna Covid-19 vaccine), VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (felt tired after receiving each Moderna Covid-19 vaccine). At the time of the report, ASTHENIA (patient says that she was in bed for about a day after each Moderna Covid-19 vaccine), VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (felt tired after receiving each Moderna Covid-19 vaccine) was resolving.            No concomitant medications were reported.  The patient was in bed for about a day after each Moderna Covid-19 vaccine. Patient drank a lot of water and felt better.  No  treatment medications were reported.   This case was linked to MOD-2022-482710 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-Feb-2022: Follow-up was received and contains no new information.
Headache for 2 day. Swelling hands feet on day 10/26/11. This aggravated his pre-existing neuropathy. Once swelling resolve so did other symptoms.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECT COVID-19 INFECTION; 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, batch number: Unknown, Expiry Date: UNKNOWN) dose was not reported, 1 total administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an APR-2021, the patient was diagnosed with suspected covid-19 infection, and on unspecified date patient experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product complaint number: 90000176122. This case, from the same reporter is linked to 20210423095.; Sender's Comments: V0: 20210423108-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Suspected clinical vaccination 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.
Expired vaccine administered to 155 patients/ 80 Patients received expired moderna COVID-19 vaccine; Vaccine expired on 01-Apr-2022 and date moved to refrigeration on 04-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients/ 80 Patients received expired moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022 and date moved to refrigeration on 04-Apr-2022) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) milliliter. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients/ 80 Patients received expired moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022 and date moved to refrigeration on 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients/ 80 Patients received expired moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022 and date moved to refrigeration on 04-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that pharmacist thought the vaccine expiry was on Jun 2022, however vaccine expired on 01 Apr 2022. Date the vial was initially stored in refrigerator was found to be 04 Apr 2022. Vial did not undergone any temperature excursion. No treatment medications were provided
Significant left arm pain, swelling; high fever; myalgias; headache; significant GI symptoms including nausea, vomiting, abdominal pain and cramping
75y.o. female with a past medical history of PE, DVT on Eliquis, GERD, hypertension, thyroid cancer, hypothyroidism who presented to the ED for chief complaint of abnormal labs.  Patient noted to have hemoglobin of 6.5 on routine labs ordered by PCP.  Patient reported fatigue recently and believed that she may have contracted COVID 3 weeks ago from her husband however tested negative twice at home with the latest being 2 days ago.  She was found to be COVID-positive in the ED, she is fully vaccinated.  Initial labs remarkable for hemoglobin of 6.5, stool guaiac negative.  Patient was transfused 1 unit and of PRBCs.  She is admitted with consult to GI service and hematology. Patient underwent EGD/colonocsopy on 10/12
No additional AE reported.; dose of PROQUAD was inadvertently administered to an adult.The nurse reports that the consumer was at the office for a physical and was supposed to receive an MMR-II booster; dose of PROQUAD was inadvertently administered to an adult.; This spontaneous report was received from a registered nurse and refers to an adult patient of unspecified age and gender. The patient's pertinent medical history, concomitant medication, past drug reactions or allergies were not reported.  On 03-NOV-2021, the patient was inadvertently vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rHA (recombinant Human albumin) (PROQUAD) at a dose reported as 0.5 (units not provided) (dose number, vaccination scheme frequency, route and anatomical site of administration were not provided; lot number T036738 that was verified to be a valid lot number with an expiration date reported and established as 28-APR-2022) for prophylaxis (product administered to patient of inappropriate age). However, it was reported that the patient was supposed to receive a Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) booster (wrong product administered).   No additional adverse event was reported (no adverse event).
MA administered Men B Bexsero to patient 11 years of age. No reactions reported to date.
Patient was fussy, extremely sensitive and cried hysterically for 24 hours while awake.  Fever of 100.0 degrees.
On Friday 1/25/08 at approx. 11am patient developed rash with hive-like component on both inner thighs and some on upper thighs.  The rash later developed into chicken pox-looking then scabbed over.  Also, developed pain in his hip joints that progressed to severe pain leading him to go to bed, unable to walk due to the pain.  By approx. 4pm on Sunday 1/27/08, pain had subsided completely and patient returned to ambulatory status.  By Monday, 1/28/08 at approx 1pm, only a small amount of rash is still present.
Received vaccine on 12/28/2020  @ 930am.  By 7:00pm  left deltoid  was tender to touch. Redness , swelling  at site. on 12/29/2020 the redness and swelling had increased to  1 inch  wide x 3 inch like a band across my deltoid , It is tender to touch and  itchy.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Overweight" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: pfizer / biontech (dose 3, Vaccine location=Left arm), administration date: 18May2023, for covid-19 immunisation; pfizer / biontech (dose 2, Vaccine location=Left arm), administration date: 28Sep2022, for covid-19 immunisation; pfizer / biontech (dose 1), administration date: 04Apr2022, for covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was taken from 20Oct2023 to 24Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Erythema, induration and warmth at injection site (Deltoid), axillary node.
I went for my annual wellness check on November 23, 2021 and my Doctor said my BP was elevated.  I had not had a BP issue before this. He did a second check and confirmed it.   He asked me to come in the following week, November 29 for another check. It was still elevated.  He asked me to start checking daily and send him the results.  BP remained elevated so we made an appointment for January 28, 2022, 8:00 am.  I continued to document my BP up to that time.  He placed me on Lisinopril 10Mg tablets 1 per day and that has brought my BP under control over the next month and I have been cutting back on the medication.  I seem to be in good health now.
father reported that p/vax pt had bruising all over, fatigue lasting one month;pt has factor V Deficiency;
I've had tinnitus in both ears about 1-hour after my first dose of Moderna.
17 y/o inadvertently given Moderna 4 weeks ago.  Per CDC guidelines, 2nd dose given per recommended interval.
she developed COVID; This non-serious case was reported by a consumer via call center representative and described the occurrence of covid-19 in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced covid-19 (Verbatim: she developed COVID). The outcome of the covid-19 was resolved.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     It was unknown if the company considered the covid-19 to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR099052   Additional Information: GSK Receipt Date: 17-JUL-2023 The reporter was the patient.  The patient received her first Shingrix dose about 2 years ago. The patient didn't receive the second dose within six months because she didn't know she needed a second dose and because she developed COVID. The reporter consented to follow up. This case had been linked with US2023AMR099052 due to same patient and reporter.; Sender's Comments:  US-GSK-US2023AMR099052:Same reporter, different dose
45mins post vax pt exp dizziness, h/a, cold sweat, vision blurred; tx observation, UA sample, DPH; pt recovered 15MAR96;
8 days after vac, arm was swollen and itchy, neck and shoulder very sore, pain in the elbow radiating down through my arm and into my hand.
Developed significant Atrial Flutter with no prior history of any cardiac issues.  Hospitalized for 6 days.  Initial treatment with Cardizen IV with dose rate ranging from 2.5 mg/hr to 15 mg/hr.  Released with Cardizen oral route 240 mg/day (120 mg BID) plus 100 mg Metoprolol ER (50 mg BID).  Cardiac physician follow-up pending.  Family caregiver (son) also experienced cardiac arythmia (PVCs) about 24 hours after same booster dose.  These PVCs resolved after about a day and have not returned.  It cannot be coincidence that two people with absolutely no history of cardiac issues both experience heart arythmias shortly after receiving the Moderna booster.