chrisvoncsefalvay/vaers-outcomes huggingface dataset:
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; 190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant products were not provided. Unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment medication were not reported. This case was for the 12th patient out of 190 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER  CASE
Approx. 15 minutes, post vax, she noted a metallic taste in her mouth and 5 minutes later, noted numbness in both lips; 15 minutes later, lips remained numb and then had numbness in nose. Numbness progressed up face and then a bright red body rash appeared with itching. She was given Benadryl with most of symptoms resolved. Later, was given Benadryl again. Temperature was 99F, P-68 and BP 150/86.
A report has been received from a Health Professional concerning a 11 year old, Female subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 05-Nov-2014. The patient experienced PATIENT RECEIVED AN INFLUENZA INJECTION AND FLUMIST ON THE SAME DAY which started on 05-Nov-2014. The outcome of the event of PATIENT RECEIVED AN INFLUENZA INJECTION AND FLUMIST ON THE SAME DAY is unknown. The report was considered to be non-serious.
Rash on arms, neck, both  legs,  foot, wrist.  A small one on left breast.   Swelling and Very Itchy - After one stop itching another pop up.  Hydrocortisone Cream does not work.  Ice is the only comfort. Stops swelling.  Usually last in each spot about 4 to 5 days.
Varivax given approx 30-40 minutes later fine red raised rash face, ears, neck shoulder. Epi and Benadryl given.
A report was received from a health care professional on 11/04/2003 concerning a 9 month old male vaccinee who inadvertently received Fluvirin on 10/29/2003. the vaccinee had not experienced any adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 11/25/2003: A follow up report was received from a health care professional which indicated that the vaccinee was 11 months old when he received Fluvirin on 10/28/2003. The vaccinee had still not experienced any adverse reaction at the time of the report. No follow up pending. See Ref.: PJP200300983 and PJP200300985.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pacemaker" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 12Dec2022 to 17Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Large splotchy rash on upper half of arm, chills, body aches, headache and tiredness. No energy.
Received vaccination 8/18/22, symptoms started 8/26/22 - states it started with intermittent mild headache which has progressively worsened to constant headache with fatigue along with 1 day of fever (unknown tmax)
14 hours straight:   Intense headaches .  Overall body aches.  Loss of appetite.  Extreme tiredness, sleepiness.  Stomach unsettled - somewhat nauseous.
red rash (itchy- but painful) below injection site (began two days after injection) - currently improved according to patient.
Patient had no reaction, 2nd dose was given 7 days early  Patient Patients wife informed us that he was not going to be able to make it to his schedule appointment at facility due to getting off of work late. Facility had an open slot and CTS and FDS  scheduled patient and we did not double check that he was early for his second dose. MA saw patient and administered the vaccine and when she went to put the information in the system it prompt the red flag that patient was 7 days early for his vaccine. Consulted with Dr. and another Doctor said it was okay not to worry but patient would need to come back on 2/28 to get the right dosage. Spoke to patient and explain the situation and patient was understanding.  Consulted with Dr and another Doctor said it was okay not to worry. The plan is for patient would need to come back on 2/28 to get the right dosage. Spoke to patient and explain the situation and patient was understanding. Can you close this loop resolution already made and plan is expected to be complete on 2/28.
Guillain-Barre Syndrome  4/25/08 Reviewed hospital medical records of 3/11-3/20/2008. FINAL DX: Guillain Barre syndrome. Records reveal patient experienced fatigue, pallor, urinary urgency, progressive difficulty walking w/pain & heaviness in his legs, penis & back x 2 weeks resulting in several falls.  Immediately s/p vaccine, experienced flu-like symptoms which resolved w/n 24 hours.  While hospitalized developed increased LE weakness, areflexia.  Neuro consult done.  Tx w/IVIG x 5 days.  D/C to inpatient rehab facility for continued PT.
ended up testing positive for covid/had mild symptoms; This is a spontaneous report from a contactable consumer (patient). A patient of unknown gender received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), via an unknown route of administration on 10Feb2021 as a single dose for COVID-19 immunization. The relevant medical history and concomitant medication were not reported. The patient had mild symptoms after shot and decided to get tested for COVID on Thursday 18Feb2021 because the patient was still having mild symptoms. On Saturday 20Feb2021, the patient tested positive for COVID. The clinical outcome of the event was unknown.  Information of lot and batch number has been requested.
Underdose; pediatric dose of Engerix-B was given to an adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 66-year-old male patient who received HBV (Engerix B pediatric) (batch number 77X47, expiry date 22-DEC-2023) for prophylaxis.   On 22-MAY-2023, the patient received Engerix B pediatric. On 22-MAY-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Underdose) and adult use of a child product (Verbatim: pediatric dose of Engerix-B was given to an adult patient). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 22-MAY-2023 Nurse calls to report a pediatric dose of Engerix-B was given to an adult patient, which led to underdose and adult use of a child product. The reporter consented to follow up. Follow up via email agreed.
This case was reported by a healthcare professional via a sales representative and described the occurrence of burning down arm in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX (unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced burning down arm. At the time of reporting the outcome of the event was unspecified. Follow-up information received on 08 July 2008 indicated that the subject was a 39 year old male. At the time of injection of the 2nd dose of TWINRIX, intramuscularly, the subject experienced burning down the arm and aching at the time of injection. The events resolved and were considered by the reporter to be related to treatment with TWINRIX. The reporter stated that she has had several clients in the past 2 to 3 months complain of these symptoms at the time of injection without ongoing effect.
Between 5 and 10 minutes after receiving her vaccine, patient reported feeling light-headed and dizzy, together with being nauseated,  A few minutes later, she had emesis with watery, yellowish contents.  Patient reported this was what she had for breakfast.   She next reported having chills.  VS were taken and were WNL: HR 99, SPO2 96%, B/P 112/88 RR 20.  Pt recovered after 30 minutes of observation.
Stomach is upset; Arm is swollen; Red; Low grade fever; Very nauseated; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach is upset), PERIPHERAL SWELLING (Arm is swollen), FEELING ABNORMAL (Red), PYREXIA (Low grade fever) and NAUSEA (Very nauseated) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (ALLERGAN) and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, Lizum for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach is upset), PERIPHERAL SWELLING (Arm is swollen), FEELING ABNORMAL (Red), PYREXIA (Low grade fever) and NAUSEA (Very nauseated). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Stomach is upset), PERIPHERAL SWELLING (Arm is swollen), FEELING ABNORMAL (Red), PYREXIA (Low grade fever) and NAUSEA (Very nauseated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Pyrexia: 99° to 100° (Low) 100°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Action taken with mRNA-1273 in response to the event was not applicable.
After shot #2 I had gut micro-biome distress, bloating, constipation, large intestine full, small intestine not  getting full, so block between large and small intestine.  Drank smooth move tea, massage bloated tummy, had acupuncture to help ... mostly drank tea and water for a few days.  Finally had some relief, but now 5 days later I am still not back to normal gut function.  I am taking probiotic tablets with meals.
Redness/swelling approximately 6 inches below the injection site without pain/itching/discomfort lasting approximately 7 days.
Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case is linked to cases 2018SA315702 and 2018SA315703. This case involves a 15 years old female patient and reported that received a Flublock Quadrivalent that day in her left deltoid, IM, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 12-Nov-2018, the patient received a dose of 0.5 ml suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QSAA1804 and expiry date: 01-Jun-2019) via intramuscular route in the left deltoid. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if the patient had any adverse 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 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. List of documents held by sender: none.
After receiving High Dflu vaccine pt had taste in her mouth flushing on face and neck ache down her neck toward her back, within 15 mins felt better by 350PM. BP was 122/62 with SX symptoms. Never had problem with "flu shot" previously. No problem with PNEUMOVAX given 1st.
6 days after receiving VZV#2, felt cold and had sore throat, day 8 or 9 post vaccination, noticed rash to back of neck with itching; 15 days post vaccination, increased sore throat and nasal congestion
Patient with 3 COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "72yo female with hx of COPD, chronic hypoxic respiratory failure, anxiety, bipolar disease, CAD s/p stent, HTN, HLD, hx of seizures who reported to Hospital ED with acute complaint of shortness of breath. At home, patient uses supplemental oxygen at 1L per which she required an increase in supplemental O2. She was developing worsening chronic cough with productive sputum. Reported generalized fatigue prior to arrival. She denied fever, chills, rigors, orthopnea. Patient took a home COVID test which was positive on 10/21/22.    In the ED, patient was afebrile and hemodynamically stable. SpO2 2was 96% on 2L. She initially was found to have increased work of breathing and placed on BiPAP. She became hypotensive to 87/35, fluids were administered. Patient received Ativan and was transitioned to CPAP from BiPAP. WBC was 16.2, COVID was positive. Chest XR remarkable for bibasilar reticulonodular opacities.    Hospital Course:  Patient was taken off BiPAP, started on Decadron and Remdesivir for COVID pneumonia. IV rocephin and doxycycline were started for COPD exacerbation. Patient's hyponatremia resolved with fluids. Patient complained of multiple episodes of loose stools. C. Diff isolation and testing protocols were initiated on 10/25/22, with negative results. Patient's loose stools improved with PRN imodium. Blood cultures continued to show no growth. She was discharged in stable condition to home with home-care after completing Remdesivir therapy and 5 days of antibiotics.   Issues Requiring Follow Up: (Who, what, when, and how communicated?) PCP - COPD exacerbation and COVID pneumonia f/u. Discharged with short course Decadron to complete 10 days therapy."
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.   This case was linked to MOD-2021-395985 (Patient Link).
Mother stated pt broke out in hives and has swollen glands. She had been taken Benadryl for itching. PA-C put on Claritin.
I contracted COVID-19 on 05/24/2022 with symptoms of fever, intermittent loss of sense of smell, runny nose, sneezing, congestion, muscle aches, fatigue, and sore throat. I was prescribed Paxlovid on 05/26/2022. I was ill for 5 days before my symptoms began to resolve. I am still experiencing intermittent loss of sense of smell and fatigue.
Patient was inadvertently given PPD (Tubersol) intramuscularly instead of TDap, with no reported adverse event; Patient was inadvertently given PPD (Tubersol) intramuscularly instead of TDap, with no reported adverse event; Initial information was received on 10-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age/gender patient who experienced patient was inadvertently given ppd (tubersol) intramuscularly instead of tdap, with no reported adverse event while receiving vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and while treated with TUBERCULIN TEST [TUBERSOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, patient was inadvertently given ppd (tubersol) at an unknown dose (lot number, expiry date, form, strength: not reported) (indication- tuberculin test) intramuscularly instead of tdap (lot number and expiry date: not reported) (indication-prophylactic vaccination), with no reported adverse event (wrong product administered) (unknown latency)   On an unknown date the patient developed a non-serious patient was inadvertently given ppd (tubersol) intramuscularly instead of tdap, with no reported adverse event (incorrect route of product administration) (unknown latency) following the administration of tubersol.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event patient was inadvertently given ppd (tubersol) intramuscularly instead of tdap, with no reported adverse event and was Unknown for the event patient was inadvertently given ppd (tubersol) intramuscularly instead of tdap, with no reported adverse 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 guidelines. 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.
6APR98 mom describes as approx 4x5 in area on upper, lt arm raised, red, warm to touch, hard;first noticed 5APR98 PM larger & worse by Monday 6APR98 AM;appointment made w/MD;
Monday evening after vaccine - fever over 101, chills with uncontrollable shaking, rapid heartbeat that could be felt within eyes, nausea, muscle aches & pain - including back and left leg  Tuesday morning through Thursday - lower fever, pain in leg continued, shortness of breath, fatigue
Migraine headache; Very tired; Flu like symptoms; Brain fog; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine headache), FEELING ABNORMAL (Brain fog), INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Very tired) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced FEELING ABNORMAL (Brain fog). On 06-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 07-Feb-2021, the patient experienced FATIGUE (Very tired). On 09-Feb-2021, the patient experienced MIGRAINE (Migraine headache). The patient was treated with IBUPROFEN at a dose of 800 mg. At the time of the report, MIGRAINE (Migraine headache), FEELING ABNORMAL (Brain fog), INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included ibuprofen.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
On 03/05/2023 I was experiencing sore throat cough and chills. After reaching out to my doctor I was diagnosed with Covid-19. I was prescribed Lagevrio. Symptoms lasted a week.
Fever and headache started the evening  that the vaccine was given. Fever got up to  102-103. Symptoms lasted about a week.  Seen in clinic 2 days after vaccine - had a  normal exam.
Patient felt lightheaded after administration of HPV vaccine. Patient assisted to lying down on exam table and given cool cloth on forehead. Blood pressure taken 104/64. Patient remained lying down for approximately 10 min. Patient then states she feels better and assisted to sitting position. Patient given a drink of Mountain Dew. After sitting for several minutes patient assisted to standing. Patient states she now feels normal.
One day after the second dose of covid 19 vaccine (pfizer) I had severe chest pain for about 3 hours.  The pain came and went every few minutes. I went to the ER, they did an EKG which was normal,  monitored my heart rate for several hours and did bloodwork,  all of which was normal.  Eventually the pain went away on its own. Earlier in the day I'd had a fever of about 101 and took tylenol for that. I was 33 weeks pregnant at the time (due date June 29 2021). There is no sign that the baby was affected at this point.
I broke out in hives about 24 hours after the shot. I took BENADRYL and used hydrocortisone. The hives remained for about three days. I called the Tele-Doc and sent pictures. He said to only get the nasal vaccine with no eggs going forward and that I am now fully allergic to eggs. The hives went away by day four.
Pt. developed generalized erythematous rash with hives and had low grade fever (100 degrees F).