chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sunday: vaccine Monday: lethargy and migraine Tuesday: chills, fever, migraine, lethargy, congestion, sore throat, body aches Wednesday: same as Tuesday and itching begins Thursday: rash on face and neck, fever, lethargy, body aches, yeast infection Friday: hives form on face and neck, rash appears on both arms and chest, vaginal pain and swelling begin  Saturday: rash continues, congestion, sore throat, mild fever, lethargy, hives appear on legs Sunday: symptoms continue
Tx with BENADRYL head to toe rash one hour following vaccination - patient got a rash that was not as severe last year to the H1N1 vaccine, but mom did not report that on administration form.
This spontaneous report was received from a pharmacist and refers to a 66 year old female patient. The patient's pertinent medical history included arthritis. No information regarding the patient's drug reactions or allergies and concomitant therapies was provided. On 09-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # L012215, expiration date: 13-JAN-2017, dose and route of administration were not provided). The injection was given in the triceps area, rather than in the deltoid area, as recommended per the pharmacy protocol. On 09-SEP-2016, the patient noticed, that her arm was extremely sore, warm and had a red area around the injection site. The following day, the patient reported to the pharmacist that, she could hardly bend her elbow, the elbow was swollen to the point that the normal wrinkles around the elbow could not be seen, the upper arm was swollen, hot to touch, and had a red area about six to six and one half inches in diameter, as well as soreness. The swelling traveled down into the patient's elbow and a little below the elbow on day 2 but that the injection site pain was less noticeable. The patient sought medical attention. The outcome of peripheral swelling, injection site redness and injection site warmth was unknown. The outcome of injection site pain was considered as recovering/resolving, as the pain was less noticeable. The relatedness between the events and PNEUMOVAX 23 was not provided. Additional information has been requested.
Fully vaccinated and boosted 11/8/21.  Covid breakthrough.   Inpatient hospital stay.
Information has been received from a registered nurse concerning an approximately 12 month old female who was vaccinated with her first 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (no lot number available). Concomitant vaccinations administered that same day included "standard vaccines at 12 months of age." In 2007 within 4 months after vaccination, the patient developed 15 lesions. Unspecified medical attention was sought. The outcome was unknown. There was no product quality complaint. Follow-up information received from the reporting registered nurse indicated that a 7 year old female with no pre-existing conditions or allergies who on approximately 13-SEP-2001 and 14-SEP-2007 was vaccinated SC with the first and second doses of varicella virus vaccine live (Oka/Merck) (lot# 1105U) in the left arm. There was no illness at the time of vaccination. No other vaccines were administered within 4 weeks of second vaccine. On 20-SEP-2007 the patient started breaking out with red bumps 50 or so (previously reported as 15 skin lesions) in the pubic area, legs, neck, scalp and back as reported by patient's mother. The patient also developed clear pustules on the red bumps that were itchy. It was noted that the pustules did break open and crust over. There was no fever. The child was not seen at clinic, but her mother called for advice to see if child was contagious. No labs or diagnostic studies were performed. Subsequently, the patient recovered. This is one of several reports from the same source. Additional information has been requested.
Patient administered vaccine after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.  It was reported that vials had not undergone any temperature excursion.Total of 168 doses/vials were given for LOT  048C21A.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up contains Non Significant information.
Vaccine got expired on 01-Apr-2022, was refrigerated on 04-Apr-2022 and administered on 11-Apr-2022; Vaccine was expired on 01-Apr-2022 administered on 11-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 11-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine got expired on 01-Apr-2022, was refrigerated on 04-Apr-2022 and administered on 11-Apr-2022) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 11-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine got expired on 01-Apr-2022, was refrigerated on 04-Apr-2022 and administered on 11-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 11-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine got expired on 01-Apr-2022, was refrigerated on 04-Apr-2022 and administered on 11-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported The vial was initially put in the refrigerator on 04-Apr-2022.The vial did not undergo any temperature excursions.The pharmacist thought that vaccine will expired on Jun-2022, however vaccine was expired on 01-Apr-2022. No Treatment medication was reported
Patient received vaccine at 10:30am. Soon after reportedly felt light headed and dizzy. Rph notified and precautionary measures taken place (Epi prepared, masks, etc). BP was 176/115, Pulse : >100 shortly after - about 5-10 minutes following vaccination. Pt began experiencing tremors. Rph called 911 - EMT arrived, but patient refused ambulance ride. Daughters took her to local ER. Pt reportedly fine in the days following - only a little fatigue after the ER visit.
Light headed, dizzy, sweaty, ears ringing for a few seconds. Patient was evaluated by EMS and recovered.
increased HR up to 130 bpm; shortness of breath; lightheadedness; fatigue; This is a spontaneous report from a contactable other healthcare professional (Nurse). A 63-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date (at the age of 63-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. One month after receiving the second dose of the vaccine, on an unspecified date, the patient experienced shortness of breath, increased heart rate up to 130 bpm, lightheadedness, fatigue. The patient underwent lab tests and procedures which included heart rate: 130 bpm. She wants to know if there any been any other reports of any cardiac issues one month after receiving the second dose of the vaccine. Outcome of the events was unknown. Response: Reviewed attached FACT SHEET FOR HCPs ADMINISTERING VACCINE and no information found regarding cardiac related events post vaccination. Spoke from attached FAQ-COVID-19 Vaccine-Pfizer Response to Reported Cases of Myocarditis in Recipients of COVID-19 Vaccine and Serious and Severe Adverse Events. Offered to send pdf document via email, caller declined. Referred to HCP Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, increased heart rate, Dizziness, Dyspnea, Fatigue cannot be completely ruled out. The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethic committees, and Investigators, as appropriate.
Mid-grade gout flare left ankle; This is a spontaneous report from a contactable other hcp (patient). A 51-years-old male patient received first dose of bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration, administered in arm left on 15Jan2021 10:00 (Batch/Lot Number: EL1289) as SINGLE for covid-19 immunization administered at hospital. The patient medical history included obesity, high blood pressure and high uric acid from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not have COVID-19 prior to vaccination. The patient had no known allergies. The patient's concomitant medications were not reported. On 19Jan2021 08:00 (Three days after first dose), the patient experienced mid-grade gout flare left ankle which resulted patient in Doctor or other healthcare professional office/clinic visit. The patient treatment received was unknown. The patient had not tested positive for COVID-19 since the vaccination. The outcome of events was recovering.  Follow-up attempts completed. No further information expected.
This spontaneous case reported by a nurse, describes the occurrence of product administered to patient of inappropriate age (received first dose of Moderna COVID-19 vaccine under 18 years of age) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 006D21A) for COVID-19  immunization. No medical history reported. On Sep 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 23, 2021, patient experienced product administered to patient of inappropriate age (received first dose of Moderna COVID-19 vaccine under 18 years of age). On Sep 23, 2021,  product administered to patient of inappropriate age (received first dose of Moderna COVID-19 vaccine under 18 years of age) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments. No concomitant medication or treatment information reported. No adverse reactions following vaccination as per the nurse. The nurse stated patient waited 15 minutes after vaccination and he was fine. This case linked to MOD-2021-330210 (patient link).
This spontaneous report was received from a physician regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, the patient were vaccinated an improperly stored doses of ROTATEQ (orally, dose was not reported, lot # L006184 with expiration date 13-DEC-2016 or lot # L027067 with an expiration date 06-APR-2017). There was no adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high BP" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: Jan2022, stop date: Oct2022; BUPROPION, start date: Jan2022, stop date: Oct2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Oct2022) Negative, notes: Tested negative with little to no symptoms 2 days after complete treatment; (21Oct2022) Positive, notes: then 6 days after  completing treatment have fever, aches and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had received other medication in 2 weeks. Tested negative with little to no symptoms 2 days after complete treatment, then 6 days after completing treatment have fever, aches and tested positive. Patient had not known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Son stated in am woke up and had night sweats early morning Temp 99.1  Felt congested stuffy took some Motrin  went to school came he is a runner said he felt cold coming in chest lungs were clear just very tired when he ran next morning 10/02/2010 stated tired stuffy felt chills again at night went away went to school came home chest felt like cold  coming on lungs clear had cross country meet next am couldnt finish race due to lower mid cramp/pain  dr checked him out IMMED AFTER   rested drank fluids next am no stuffiness, pain no night sweats no further s/s usually when he starts with a cold he becomes very congested cough but this resolved after a few days   dont know if related to shot but i wanted to report
The pt experienced a local reaction, complained of pain, swelling, redness and itching. Treated with Benadryl.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 (lot # N025429) for prophylaxis. On an unknown date the patient experienced product storage error and no adverse event. The outcome of product storage error and no adverse event is unknown. The reporter considered product storage error and no adverse event to be not assessed to GARDASIL 9.
Patient visited ED 22 days after receiving first covid shot. Patient passed away 33 days after receiving first covid shot.
DEVELOPED A HIGH FEVER OF 105.1 THE SAME DAY OF THE VACCINE(MMR, VERICELLA, PREVNAR), TWO DAYS AFTER, MY SON STARTING VOMITING. THE FOLLOWING DAY HE BEGAN TO SWELL IN THE EYE AREA; THEN HIS FACE BEGAN TO SWELL AS WELL WITH REDNESS. LOOK LIKE HE WAS COMING DOWN WITH THE MEASLES OR MUMPS. TODAY HE STILL HAVE THE SWELLING IN THE FACE AND JUST GETTING OVER WHAT THE DOCTORS CALLED A STOMACH VIRUS. I BELEIVE IT WAS A ALLERGIC REACTION MYSELF. MY SON WAS PERFECTLY FINE AND FULL OF ENERGY BEFORE THE VACCINES. NOW HE IS A COMPLETELY DIFFERENT TODDLER AT THE MOMENT. I HOPE HE MAKES A FULL RECOVERY FROM THOSE VACCINES THAT WERE GIVEN AT THE SAME TIME. THE DOCTOR STATED THAT IT WAS NORMAL, SO NO TREATMENT WAS GIVEN ONLY FOR THE HIGH FEVER.
One hive on face and one hive on neck about 4.5 hours after vaccine administered; went to emergency room Emergency room physician advised me to take Benedryl and report to hospital if condition worsened I had a single hive appear about every other day for a week following the vaccination; reported all symptoms daily to Vsafe.cdc.gov I followed up with my primary physician and my allergist for approval to get the second dose - recommended that I pre-medicate with Zyrtek and Pepcid prior to my second dose
pain; redness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number ZP3P9, expiry date 10th September 2021) for prophylaxis.   On 30th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 2nd May 2019, 2 days after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that a patient received Shingrix in left arm and experienced injection site redness and pain.  Diameter of redness ranged from 2.5 inches to 5 inches at time of call. The patient had not sought medical attention. The pharmacist consented to follow up.
Woke up with chills and whole body aches almost 12 hrs. After injection. Chills lasted around 3 hrs. I then had extreme fatigue, nausea and headache for another 10hrs.
On 1/29/21 patient began not feeling well and saw her provider.  The doctor gave her fluids and tramadol for pain.  They noticed increased confusion, but thought that could have been due to the tramadol.  They also increased her gabapentin as she was experiencing nerve pain.  Patient also developed a rash and was diagnosed with shingles on 2/1/21.  Patient died on 2/3/21
pediatric patient who received about half of the Fluzone Quad 0.5; Initial information received on 10-Oct-2019 and additional information on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves pediatric patient who received about half of the 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot number not reported via unknown route.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to vaccine underdose.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error  Information on the batch number was requested  List of documents held by sender: none
pt recvd flu vax & devel psychotic reaction characterized by confusion, agitation,hallucinations & horrifying dreams & required hospitalization & tx w/Haldol;
Shortness of breath and tightness in chest. Feels like a heart palpitations. Anxiety.
More recently (around 2/1) he started having intermittent chest pressure again, then developed dyspnea, cough, intermittent mild fever ~ 101, and hypoxia noted on home monitor. Felt to have pneumonia and was placed on antibiotics 2/4/21 without improvement of symptoms. Seen by his PCP on the day of admission, he was much more dyspeptic and tachycardic with heart rates in the 150s.  He was sent to the ER for further w/u and management.
Large red area swelling and inflammation thigh (local) about 3 cm x 5 cm.
This spontaneous report as received from a 72 year old male consumer referring on himself. With no pertinent medical history or drug reactions/allergies. Approximately in January-2008, reported as six years ago, the patient was vaccinated 1 time with ZOSTAVAX to prevent shingles (dose, route, lot and expiration date were not reported). Concomitant therapies included gabapentin (manufacturer unknown) also reported as gabapentin. In June 2013, the patient stated that he had the shingles, after getting ZOSTAVAX. The patient sought for medical attention and was treated with a prescription medication. No lab diagnostics were performed. The outcome for shingles was unknown at the time of the report. Additional information has been requested.
got the shot today, have shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 8th July 2022, the patient received Shingles vaccine. On 8th July 2022, less than a day after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 8-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shot on the day of reporting and also found out that he/she have had shingles. Additional supportive information: The follow-up could not be possible as no contact details were available.