chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 7 almost 8 year old female patient with amoxicillin allergy who in 2005 was vaccinated with the first dose of VARIVAX (Merck) (dose, route and lot # not reported) and in 2009 was vaccinated with the second dose (dose, route and lot # not reported) and on 24-APR-2012 was vaccinated subcutaneously with the third 0.5 ml dose (lot # 143AA is an invalid lot number for VARIVAX (Merck)). On 26-APR-2012 the patient experienced a rash. On 26-APR-2012 the patient was seen in the office for the rash. She was given erythromycin and over the counter ZYRTEC. At the time of report, the patient's outcome was unknown. Follow-up information has been received from other healthcare professional refers to a 7 years old (currently 8 year old) female patient (child). On 24-APR-2012 at 10:00 AM, the patient was vaccinated in right upper arm with the third dose of VARIVAX (Merck) lot number "143AA" (route and dose not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on 24-APR-2012 (previously reported as on 26-APR-2012), the patient experienced rash on trunk, no fever, no malaise, no loss appetite or nausea, rash not painful. At the time of report, the outcome of "rash/rash on trunk/rash not painful" was unknown. The relatedness for the patient's event was not reported for VARIVAX (Merck). This is one of several reports from the same source. Additional information is not expected.
light-headed; anxiety; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light-headed) and ANXIETY (anxiety) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included METFORMIN, ATORVASTATIN CALCIUM (LIPITOR) and LISINOPRIL for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (light-headed) and ANXIETY (anxiety). At the time of the report, DIZZINESS (light-headed) and ANXIETY (anxiety) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-034353, MOD-2021-034353 (Patient Link).
Rash from head to toe that looked like the measles. Extremely fussy and uncomfortable. Did blood work and levels were high and doctor confirmed that the vaccine gave him the measles.
The patient received third/booster dose of BNT162b2; Sore arm; headache; body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an 17Nov2021 at 17:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 02Mar2021 at 11:00 (at the age of 48-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. On an unknown date in Nov2021, the patient experienced sore arm, headache and body aches. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event sore arm, headache and body aches was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Myalgia, fatigue, sob Narrative:  Other Relevant History:
severe eczema flare up; This is a spontaneous report from a contactable consumer. This consumer reported for a patient.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0173), via an unspecified route administered in Arm Left on 04Jun2021 as unknown, single for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since, vaccination, the patient was not tested for Covid-19. On an unspecified date, severe eczema flare up requiring steroid shot. prescribing doctor said that, the patient was the second patient to have this reaction to the vaccine that he had seen just that day. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021691179 same reporter/drug/AE with different patient
2 minutes after administration pt reported nausea, appeared flushed in face, then reported shortness of breath and chest pain. There was no blood when aspirated syringe prior to administration.  Pt had no known allergies.  02 applied, EKG ordered, MD paged.  VS stable, sp02 95% on 4 liters.  Pain subsided within next 10 minutes, sp)2 94% on RA.  PT's DC home was delayed 1 hour.
Fever 99.2 on 11/18/14 in the morning. Vomiting began at 10:00 pm after bottle. Vomiting continued into next day with bottles. Diarrhea as well along with stomach cramping and pain and crying. Treated in ER for deyhydration and possible intussusception.
Started taking Tylenol (1000mg each time noted throughout) at 2p on 5/12/21 to hopefully prevent symptoms and help with sore arm (details below). Took again at 8p. About 2:30am (5/13), woke up to shaking chills. Took Tylenol. Lasted for several hours until about 5am. Also had body aches (back soreness) during this same time. Took Tylenol at 7a. At 11:30am on 5/13, started to have shaking chills again with body aches and extreme exhaustion. Took Tylenol at 12:30p. Had tiredness and aches evening of 5/13. Took Tylenol at 6p. On morning of 5/14, had fever (99.3) which resolved with Tylenol. Had extreme tiredness for the whole day, but no other symptoms. On 5/15, woke up with a headache and feeling of fever (did not take temp), treated with Excedrin and headache and fever feeling resolved. No further symptoms. Sore arm from injection started 2pm on 5/12 (sore to touch) and got more severe on 5/13 (could not lift arm and was constant soreness).  Was very mildly sore on 5/14 (felt like a bad bruise, only sore to touch) but had a softball-sized red patch around the injection site. No itching of the redness; did not have bumps/scales. Redness lasted until 5/16 and resolved on it's own (no treatment).
Patient had suspected immune reaction. Patient has lost sleep. Arm has pain without swelling. Patient has seen doctor and has had Medrol DP + Sleep medication. Symptoms have improved as of 1/5/09, but are still ongoing.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patients experienced fever and chills. On an unknown date, the outcome of the fever and chills were unknown. It was unknown if the reporter considered the fever and chills to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional reported that about 25 per cent of patients who received SHINGRIX at their pharmacy experienced fever and chills the next day of vaccination. She states they vaccinated well over 100 patients. No additional information was available.
A physician reported that a 5 1/2 year old male received Acel-Imune, IPV and Comvax on 8/25/99 and that evening developed "knots" and an injection site reaction characterized by redness and warmth at the site. The physician noted that this event was related to Acel-Imune; IPV and Comvax were administered in the opposite arm. The pt recovered. This is 1 of 5 pts from this facility who had an adverse experienced following receipt of Acel-Imune. MANUFACTURER'S COMMENT: The reporter indicate that 5 pts experienced an adverse event; however, only 4 pts have been identified. An additional report will be generated when identifying information is provided.
Dyspnea, Sinus Tachycardia, and Rigors. Accompanied by all other normal side effects.  Symptoms began at 10pm, and ended around 5am. Treated with cold medicine and acetaminophen.
Prime dose administered 5/19/21.   Patient walked into clinic on 6/4/21 too early for booster and was administered booster in error.
patient stated she had left her card with the pharmacy staff and confirmed it had been six months since last dose...and also stated she was immunocomromised.  She was also getting flu vaccine.  After the vaccine i went to give her card back and noticed it had only been since 5/22/21 since her last dose....she stood by her claim she is immunocompromised.
Information has been received from a registered nurse for the GARDASIL pregnancy registry, concerning a 12 year old female patient with anxiety who on 04-DEC-2008, 02-FEB-2009 and 19-AUG-2009 was vaccinated IM with a 0.5 mL first, second and third dose of GARDASIL (LOT # for third dose 0670Y). Concomitant therapy included BUSPAR. It was reported that at the time of receiving the third dose of GARDASIL the patient was pregnant. On 20-AUG-2009, 24 hours after the third dose of GARDASIL was administered, the patient developed nausea and vomiting which the nurse attributed to the patient's pregnancy. No laboratory or diagnostic tests were performed. On an unknown date, the patient recovered from nausea and vomiting. The patient's last menstrual period was not reported and the estimated delivery date is 03-MAY-2010. Information received on 09-DEC-2009 contained the following adverse experiences: sore throat (onset on approximately 09-DEC-2009) which was treated with amoxicillin. Additional information has been requested.
pt recvd vax 6SEP95 & 18SEP95 pt devel a local red swollen area @ inj site;25SEP95 pt devel a gen chicken pos like rash which resolved w/in 7 days w/o treatment;
About 5 hours after receiving her 2nd vaccination, developed "covid toes".  She has raised purple patches on top of her feet near her toes and on top of her toes.  It is more prevalent on her right foot.  They are not causing her pain or discomfort at this time.
had given an 11 month old the 11 year old vaccines-adacel and menactra no reported adverse event; Initial information received on 29-Jun-2022 regarding an unsolicited valid non-serious case received from health professional via sale representative.   This case involves a 11-month-old and unknown gender patient to whom vaccines Meningococcal A-C-Y-W135 (D CONJ) Vaccine [Menactra] and Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] for the 11-year-old were given no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, it was reported from hospital staff that 11-month-old patient was administered vaccines-Adacel and Menactra (all dosing details unknown) meant for the 11-year-old with no reported adverse event (product administered to patient of inappropriate age) same day latency.  Action taken: Not applicable for both suspects.  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.
Within 2 hours of receiving vaccine in left deltoid begin having neck pain and stiffness. Nuchal rigidity lasted over 24 hours. 11/21/05 now reports 2 days of weakness in arm.
T of 105 w/ sorness & redness, "rash on chest size of a quarter" & screaming lasting over 3 hrs.
7:35 am c/o arm pain, no redness or heat. Went to bathroom, called out to parent c/o tingly and hot. Pale and sweaty when I got there. When she reached for glass of water, she fainted or had a seizure. 911 called. Paramedics arrived within 10 minutes. She was alert and shaky, but vitals were normal. Paramedics said it was syncopal episode and recommended f/u with primary care provider.
pt was not able to stand, broke out into extreme sweat then vomited several times;dizziness, severe h/a & cont to vomit;when lying down felt like are was flying;sx persist next day-not as severe but w/stiffness;
Patient felt redness/swelling at the injection site and mild shortness of breath. These symptoms happened within several hours of the injection. The patient had an unknown allergy to thimerisol.
sore arm after first dose; extremely tired after taking 1st dose; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm after first dose) and FATIGUE (extremely tired after taking 1st dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K2DA) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm after first dose) and FATIGUE (extremely tired after taking 1st dose). On 05-Feb-2021, PAIN IN EXTREMITY (sore arm after first dose) and FATIGUE (extremely tired after taking 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received the vaccine at Pharmacy concomitant medications reported were OTC vitamins treatment included good sleep and hot water bottle to sore arm were taken   This case was linked to MOD-2021-350385, MOD-2021-350398 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Follow up received, contains non significant information.
Site is warm, pain in arm down to elbow. Pain in neck goes up to head. Bad headache. Scattered pain throughout. No appetite, stomach aches for 3 days. Overall tiredness.
Accidentally received a pediatric dose instead of the Moderna Covid19 bivalent booster; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Accidentally received a pediatic dose instead of the Moderna Covid19 bivalent booster) and NO ADVERSE EVENT (No adverse event) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Accidentally received a pediatric dose instead of the Moderna Covid19 bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Accidentally received a pediatric dose instead of the Moderna Covid19 bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.          No concomitant medications were provided. The patient went to receive Moderna Covid 19 bivalent vaccine dose but she accidentally received a pediatric shot. The next day, patient was contacted  by the local health department and they informed  her that she should be re vaccinated and they need to administer her with the correct Moderna Covid 19 bivalent vaccine.  No treatment information was provided.   This case was linked to MOD-2022-657514 (Patient Link).
pt recvd vax & swelling began at site of inj 2 days later; 10cm area of erythema & swelling at site of vax; warm & tender to touch; tx cloxacillin x 10 days;
she received her first Shingrix vaccination a little more than a year ago and states she did get her second vaccination, as she was unaware she needed another vaccination to complete the series; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received her first Shingrix vaccination a little more than a year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: she received her first Shingrix vaccination a little more than a year ago and states she did get her second vaccination, as she was unaware she needed another vaccination to complete the series). The outcome of the incomplete course of vaccination was unknown.   Additional Information: Receipt Date: 11-AUG-2023 The reporter stated that she did get her second Shingrix vaccination, as she was unaware and she needed another vaccination to complete the series. The minimal information obtained to file adverse event. The consent was not asked. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
TINNITUS IN BOTH EARS, NO HEARING LOSS, NO INFLAMMATION. 5 MONTHS & COUNTING
After one week, loss of apetite.  Then on  6/16/2021 in evening symptoms of nausea, fatigue, and sever abdominal pain (pain described as an 8 in a scale of 1-10.  CT scan of abdomen was negative foe appendicitis.
Patient and parents returned home approx 8pm from doctor office. Pt had vomited in his car seat. He appeared blue and limp to parents. He did not stop breathing per parents. Parents removed from car seat. Symptoms resolved. Parents took him to hospital and was admitted. Fever 101.
Nausea, headache, diarrhea, chills, aches and pains.
Every muscle in my body ached badly, the larger the muscle, the worse and the longer period of time it ached.  I could not walk normally, and people who observed me on my daily neighborhood stroll were coming out of their houses and pulling over their cars to ask if I needed help.  I felt I had to move around, as inactivity would have prolonged the agony.  Moving my right foot from the accelerator to the brake required gritting my teeth.  This lasted about 10 days, then it was another 10 days before I felt appreciatively better.
Information has been received from a nurse practitioner concerning a female (age unknown) who on an unspecified date was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL vaccine (yeast) (Lot # unknown). Subsequently, on an unknown date, the patient experienced felt dizzy and light headed for over a week after 1st dose. Therapy with human papillomavirus vaccine was discontinued. Subsequently, on an unspecified date the patient recovered. Unspecified medical attention was sought. No product quality control was involved. Additional information has been requested.
Sharp pain intermittent through whole body, especially painful in spine, base of skull, injection site, left axilla all which continued for greater than 36 hrs after injection.   Dull ache throughout body.  Fatigue. Disorganized thinking. Fever (99 and 100) 36 hrs after injection . Tylenol and ibuprofen for symptoms with temporary mild to moderate relief
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 3:20 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Nov-2021 at 3:20 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   It was reported that the vaccine was stored in an ultra cold freezer at minus 82 degrees Farenheight and 280 patients received Moderna Covid 19 stored at minus 82 degrees Farenheight.  The patient allergies were reported as unknown. It was also unknown if the patient was diagnosed with or tested positive for COVID-19.  The treatment information was unknown.
Have been getting darkening of skin/Spotting happened immediately, so the discoloration; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30May2021 (Lot number: EW0178) at the age of 22 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "Have been getting darkening of skin/Spotting happened immediately, so the discoloration". Therapeutic measures were taken as a result of skin discolouration.  Additional information: The patient wanted to report a side effect as the patient getting darkening of skin and was with dermatologist, right then nothing was working (medication unspecified). On 30May2021, the patient received vaccine on the left arm and stated that the expiration date was not available on the card. No other medical conditions and concomitant medication was reported. The patient stated that once this spotting had happened within, the spotting happened immediately, so the discoloration and seen by dermatologist and started treatment a cream with Triamcinolone acetonide ointment usp 0.1 percent for two weeks.  Follow-up attempts are completed. No further information is expected
One day post vax, the pt experienced fatigue and beginning flu symptoms. The pt also experienced difficulty breathing. The pt saw her PMD on 11/20/00.
About 20 minutes after the vaccine I got a pounding heart... later that evening I started to feel dizzy. The dizziness got worse 3 days later. I am still having palpitations and dizziness after 12 days.