chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea; lethargy; a sinus pressure headache; sinus pressure; chills; This case was reported by a consumer via call center representative and described the occurrence of lethargy in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number BA5GK, expiry date 4th November 2022) for prophylaxis.   Previously administered products included Zostavax.   On 27th April 2021, the patient received the 2nd dose of Shingrix. On 4th May 2021, 7 days after receiving Shingrix, the patient experienced lethargy, headache, sinus pressure and chills. On 6th May 2021, the patient experienced nausea. On 6th May 2021, the outcome of the lethargy, headache, sinus pressure and chills were recovered/resolved. On an unknown date, the outcome of the nausea was unknown.   It was unknown if the reporter considered the lethargy, headache, sinus pressure, chills and nausea to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The patient received Zostavax years ago, but was unsure of the date. The patient received second dose of Shingrix in left arm and did not experienced immediate adverse events. The patient experienced lethargy, sinus pressure, headache and chills.  On 6th May 2021, 9 days after vaccination, the patient experienced nausea. The patient saw a nurse practitioner, who ordered some unknown tests. The patient reported that she felt a lot better on day of reporting. The reporter consented to follow up.
Information has been received from a physician concerning an 8 year old patient who on 12/23/1997 was vaccinated with a dose of VARIVAX. Concomitant vaccine administered together with VARIVAX included a dose of MMR II. It was reported that the patient was seen on 3/29/2005 with breakthrough varicella with a mild rash and no lesions over most of the body. There was no fever. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a physician indicated that the patient experienced chickenpox, described as mild with only 10 to 15 skin lesions. Additional information has been requested.
Patient received a J&J vaccine after receiving a Moderna first dose. J&J not indicated for mix and match.
pt recv vax; at 6:10pm legs & arms stiffened, head rocked back; urinated; could not see eyes then asleep; to f/u w/ neurology; 10JUL95 ped neurologist prob sz disorder;
Mouth sores; Tingling; Inflammation; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 23Apr2021 at 13:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications included buspirone hydrochloride (BUSPAR), bupropion hydrochloride (WELLBUTRIN), sertraline hydrochloride (ZOLOFT), lisdexamfetamine mesilate (VYVANSE) and levonorgestrel (MIRENA); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Apr2021 at 15:00, the patient experienced mouth sores, tingling and inflammation. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mouth sores, tingling and inflammation was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Bloody nose and dizziness reported shortly after administration of injection. Dizziness started after nosebleed.
HCP used saline to reconstitute Menveo/ instead of using liquid conjugate component; HCP used saline to reconstitute Menveo/ instead of using liquid conjugate component; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA419A, expiry date 31st October 2021) for prophylaxis.   On 19th July 2021, the patient received Menveo (intramuscular) .5 ml. On 19th July 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided are as follows: The case was reported by medical assistant from the doctor's office. The reporter reported that the patient had been given a Menveo 0.5 ml intramuscularly in the left arm that a mixed incorrectly at the doctor's office.  The reporter stated that the health care professional used saline to reconstitute Menveo (powder form orange top vial lyophilized conjugate component) instead of using liquid conjugate component (gray top vial), which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter provided lot/expiry date from the Menveo box but did not had lot/expiry date from the vials lyophilized (orange top vial) and liquid conjugate (gray vial).  The reporter gave a consent to follow-up with health care professional. The reporter consented to follow-up.
of Covid-19 vaccine for the prophylaxis of Covid-19 infection.   According to her husband, the injection looked  like water instead of white to off-white like he read on Moderna's website. The date of the first dose of the vaccine was not provided.   Action taken with the vaccine was not applicable as the consumer received both the doses of the vaccine.  The outcome of the event, injection looks like water, not white, was considered recovered/resolved.   Follow up information is expected.; Reporter's Comments: This report refers to a case of product quality issuefor mRNA-1273 (lot # unknown) with no associated AEs reported.
Patient developed a welt and rash around the vaccine site, I waited a few days to see if it would go away before coming in to see the doctor. The day of the visit (03/09), patient had 104.9 fever and had bumps that had developed around the welt at the injection site. By 03/11/2018 patient was covered head to toe in the chicken pox rash and had several days of fever and the typical symptoms of chicken pox.
Fever of 102 developed within 24 hours of vaccine accompanied by cough/SOB ->lasted 2-3 week treated with Albuterol and ZITHROMAX. Abdominal pain ->resolved within a couple days.
Patient sates she received the covid vaccine on 9/24/21, at 8pm she "had chills, fever, weakness, fatigue, body aches, joint pain and left arm swelling. Sates "L arm swelling did not resolve until 9/27/21." She states she had these reactions with the first and second vaccines but with the booster, reactions were worse.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B1A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication information has been provided by the reporter. No concomitant medication information has been provided by the reporter. No lab data has been provided by the reporter.
Pt recvd 3rd dose of Hep B vax on 26MAR91 & on  27MAR91 exp vomiting & diarrhea which lasted 24 hrs;
Full course of chicken pox.  Fever of 104.2 began 12/28/07, lasted until 12/30/07.  Fever then went down to 102 during the day.  Chicken Pox began on 12/28/07 and continued on until 1/2/08 at which time they are fading away.  Fever broke on 12/31/07.
Pt developed ataxia after Varicella injection. Intention tremor, and worsening problems with loosing her balance. She initially had an upper respiratory tract infection with croup symptoms about 4 days prior to the onset of ataxia. Fever 102.7F, tremor
18JUN96 330Pm pc from grandma pt had been screaming since inj this AM;inj site & leg swollen & red to knee p/using tea bag, saw MD that day;pt given DPH, mom states next AM pt much better;
The patient received third/booster dose of BNT162b2; Fever after booster shot; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks of COVID vaccine. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, both as single dose for COVID-19 immunisation. On an unknown date, after booster shot, the patient experienced fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of event fever after booster shot 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.
After giving vaccination we realized patient had had a pneumovax on 2/13/21 3 days prior, this is outside the 2 week recommendation.
Vertigo; Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of vertigo in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of tinnitus (1st dose received on 29th October 2020 experienced ringing in ear and hearing loss refer case US2021021183). Concomitant products included fluticasone propionate (Flonase), methylprednisolone (Medrol) and sulfamethoxazole + trimethoprim (Bactrim Ds).   On 27th January 2021, the patient received the 2nd dose of Shingrix. In January 2021, less than a week after receiving Shingrix, the patient experienced vertigo and pain in arm. On an unknown date, the outcome of the vertigo and pain in arm were recovered/resolved.   It was unknown if the reporter considered the vertigo and pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient had vertigo and arm soreness after 2nd vaccination with Shingrix. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021021183:Same reporter.
never received a second dose; 12 year old  Vaccinated with Moderna COVID-19 Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old  Vaccinated with Moderna COVID-19 Vaccine) and PRODUCT DOSE OMISSION ISSUE (never received a second dose) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old  Vaccinated with Moderna COVID-19 Vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (never received a second dose). On 17-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old  Vaccinated with Moderna COVID-19 Vaccine) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (never received a second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were not reported. No treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received on 21-JUL-2021 contains no new information.
He woke up with severe leg pain. He was limping and had a very hard time walking. All day he has been limping on his left leg. He also experienced some throat soreness.
got a fever which climbed to 103.5 & did not respond to APAP;in the early AM of 11JUN96 had several sz/convuls of 1min or less;was extremely fearful & cried for several hr;saw MD next AM;called MD next PM;
MILD STOMACH ACHE; 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: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 08-APR-2021, the subject experienced mild stomach ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild stomach ache on 08-APR-2021. This report was non-serious. This case, from the same reporter is linked to
pt recv vax 27JAN97 & 3MAR97 pt exp Bell's Palsy;It was reported that pt rt side of face had no movement & the site was red-pt does not have a fever;
No additional adverse events reported.; a dose of expired MMRlI was administered to a patient; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 05-AUG-2021, the patient was vaccinated with an expired measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) injection, 0.5 milliliters (ml) as prophylaxis (lot number S022753 which has been verified to be valid, expiration date reported and validated as 22-JUL-2021) (route of administration and anatomical site of injection were not reported) (expired product administered). No additional adverse events were reported in the patient.
This spontaneous report as received from a registered nurse refers to 2 patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # K016263, expiration date: 26-JUN-2016) dose not reported, route defaulted to oral. No adverse effects reported. This is one of three reports received from the same source. Additional information is not expected, because there was no consent to contact the physician.
Heart attack a week later; Heart attack a week later; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm in a hospital facility on 04Mar2021 12:00 (Batch/Lot number was not reported) (at the age of 46-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no covid prior to vaccination and has not been tested for covid-19 since the vaccination. The patient was not pregnant at the time of vaccination. Medical history included high platelets. Concomitant medications included hydroxyurea and multivitamin. On 11Mar2021, the patient experienced heart attack a week later. The patient was hospitalized for the event for 5 days. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the event. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a 64 year old female consumer with no known medical history or allergies who on 20-Dec-2006 was vaccinated with a 0.65 ml dose of Zostavax vaccine. On 20-Dec-2006 the patient experienced rash above the injection site. On 21-Dec-2006 the patient recovered. Medical attention was not sought and no lab tests were performed. No further information is available.
Patient experienced violent shaking, sweats, temperature of 101, and fatigue after receiving the COVID vaccine.  Patient had COVID a moderate case in November 2020.  Was out of commission for 21 days.
Vascular headaches 3 days  Severe Joint aches  Breast swelling and under arm pain
No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and NO ADVERSE EVENT (No adverse event) in a 35-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown that the patient ever been diagnosed with or tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023).    No concomitant medication was provided.  Reportedly, It was unknown that either individual vials or intact cartons were used. Vial size was reported as 10 dose vial. The vial was initially stored in the refrigerator on 14-Mar-2023 and the vial did not undergo any temperature excursions.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:cluster case (master case)
Dizziness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 23Feb2021 16:45 (at the age of 59-year-old) as dose 1, single for COVID-19 immunization, at other facility. The patient medical history included known allergies: Morphine and COVID-19 (if COVID prior vaccination: Yes). There were no concomitant medications. The patient was not tested for COVID-19 post vaccination. No other vaccine received in 4 weeks. On 25Feb2021 09:00, the patient experienced dizziness. It was unknown if the patient received treatment for the event. The outcome of the event was reported as not resolved.  Follow-up attempts are completed. No further information is expected.
suspected vaccination failure/received the vaccine, had my first breakthrough round of Shingles; Shingles on my spine/ Shingles on a patch on my face near the left eye; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In November 2021, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccinations was not reported. The patient received the vaccine and this week had his/her first breakthrough round of Shingles. Shingles started on spine and a patch on face near the left eye. The patient further stated so far it was livable asked to get vaccinated. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022 at 10:09 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 10:09 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Treatment information was not provided. Patient took second booster dose on 02-Apr-2022 at 10:09:23