chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; HCP called to report a TE with PROQUAD.  Improperly stored. TE case reference 02490108.  No adverse effects reported.  Consent to contact is no. No additional AE/No PQC. AE cross reference cases 02490153, 02490133, 02490163, 02490160, 02490148, 02490; This spontaneous report was received from a medical assistant referring to a 04-month-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 08-SEP-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, rHA (0.5 ml, lot#: W029555, expiration date: 14-MAR-2024; strength, and route of administration were not reported) operated by a healthcare professional for prophylaxis. The vaccine administered was improperly stored and experienced temperature excursion (TE) (product storage error). No adverse effects were reported (no adverse event).    This is one of several reports received from the same reporter.
I had joint pain yesterday like flu-like joint pain which seemed like a common effect. This morning most of the joint pain has subsided except in my feet and ankles. It was painful to wear shoes and very painful to walk. The balls of my feet were the worst. Through the day my right ankle has swollen that I have fluid on the front of my ankle that is  painful to touch. Both are very painful but especially the right.  I came home and have kept my feet elevated and it is throbbing and still swollen. My left hand joints are very painful to bend the fingers and throbbing. I have taken Motrin through the day there had been no relief.
Patient presented to pharmacy with hives and welts only on right arm that she said began last night.  She was seeking a remedy to control the rash and itch.  It started 6 days after vaccine was adminstrated.
Metal in arm, magnetic objects sticking at the injection site and right clavicle; Loss of appetite; Metalic taste in mouth; hives on arm/neck; covid arm; Intense cold chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Metal in arm, magnetic objects sticking at the injection site and right clavicle), DECREASED APPETITE (Loss of appetite), DYSGEUSIA (Metalic taste in mouth), URTICARIA (hives on arm/neck) and INJECTION SITE REACTION (covid arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history was reported.  Concomitant products included AMLODIPINE and SIMVASTATIN for an unknown indication.    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Metal in arm, magnetic objects sticking at the injection site and right clavicle), DECREASED APPETITE (Loss of appetite), DYSGEUSIA (Metalic taste in mouth), URTICARIA (hives on arm/neck), INJECTION SITE REACTION (covid arm) and CHILLS (Intense cold chills). At the time of the report, VACCINATION SITE REACTION (Metal in arm, magnetic objects sticking at the injection site and right clavicle), DECREASED APPETITE (Loss of appetite), DYSGEUSIA (Metalic taste in mouth), URTICARIA (hives on arm/neck), INJECTION SITE REACTION (covid arm) and CHILLS (Intense cold chills) outcome was unknown.            No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: follow-up received on 14-JUN-2021. Contains non significant information On 16-Jun-2021: Added new event loss of appetite. Added start date of loss of appetite On 30-Jun-2021: Email: Video attached with email summarizing that her nail clipper and fork are sticking to her skin.
Narrative: COVID infection following COVID vaccine series 03/17, Pfizer, dose #1 04/07, Pfizer, dose #2 12/27 COVID swab, result: detected 12/30 COVID swab, result: detected 1/3 COVID swab, result: detected 12/27 pt cc: rhinorrhea, sore throat exposure: unknown
After covid vaccination the patient complained of dizziness, numbness, and described as feeling funny and uneasy.  Patient received the Janssen vaccine because she originally experienced a rash with the pfizer vaccine.  Pt was observed in the ED for 1 hour. Pt was relesed
Achy; Tired,felt fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) and FATIGUE (Tired,felt fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (Achy) and FATIGUE (Tired,felt fatigue). At the time of the report, PAIN (Achy) and FATIGUE (Tired,felt fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated the intensity of the events were more severe than the first Moderna Covid-19 vaccine.  Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-366366, MOD-2021-367209 (Patient Link).
2nd dose given in 2020 and 3rd dose in march 15th 2022; 2nd dose given in 2020 and 3rd dose in march 15th 2022; gave to a patient Menveo instead of Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA642A, expiry date 30th November 2022) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (received 1st dose in 2018).   On 15th March 2022, the patient received the 3rd dose of Menveo. On an unknown date, the patient received the 2nd dose of Menveo. On 15th March 2022, unknown after receiving Menveo and not applicable after receiving Menveo, the patient experienced extra dose administered and wrong vaccine administered. On an unknown date, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered, wrong vaccine administered and extra dose administered were unknown.  Additional information were received as follows: It was reported that the patient received 2nd dose of Menveo in 2020, which led to extra dose administered.  The medical assistant reported that on the day of reporting he/she gave to a patient 3rd dose of Menveo instead of Bexsero, which led to wrong vaccine administered and extra dose administered.  The reporter consented to follow up.
Another lump on 08Nov2021.; Lymph nodes in neck swollen and tender to the touch, the swelling continued to grow; Lymph nodes in neck swollen and tender to the touch; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 03Nov2021 at 12:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 13Oct2021 at 12:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 05Nov2021 at 12:00, lymph nodes in neck were swollen and tender to the touch. The swelling continued to grow and then she noticed another lump on 08Nov2021. It was reported that neither had reduced in size. The events resulted in doctor or other healthcare professional office/clinic visit. 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 lymph nodes in neck were swollen and tender to the touch, the swelling continued to grow and then noticed another lump was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Received the vaccine on Friday , 12-8-2021.  Only soreness at injection site noted the next day. Sunday , 12-10-2021  at 2 pm observed by daughter to be sniffling  and having watery eyes. Felt  body malaise and headaches .  That evening started to cough. Wheezing  episodes that night and needed to take ventolin puffs  and Breo elipta which was last used May 2020.  Monday  12- 11-2021. Had no appetite  as no sense of taste most especially in the morning. Coughing and wheezing continued intermittently.  Today, 12-12-2021 morning ,regained appetite and sense of taste. Feeling better but still has intermittent headache , coughing and wheezing. Continuing to monitor self being a nurse.
Client received Pfizer Pediatric COVID vaccine dose.  Client should have received Pfizer Bio-NTech dose.  No adverse symptoms reported during observation period.  Client left vaccine site with father once observation complete.
No adverse event; 14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, 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. In 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD).    No concomitant medications were provided.  Dosage text for suspect product was reported as unknown.  14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15 MAY 2023-10 JUN 2023. No reported symptoms at that time.  No treatment medication was provided.  This case contains information for the 10th out of 14 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732456 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732456:Master case
Mild fever, rash - maculopapular rash - generalized. Fever one day; next day rash appeared. 2/20/04 vaccine given. 2/29/04 mild fever. 3/01/04 Generalized rash.
nurse reported that approx 50% of individuals who recv flu vax @ this site devel inj site rxn characterized by pain, swelling, or warmth;no further info was available @ the date of this report;
Pfizer Covid vaccine was administered on day 33 of refrigeration, manufacturer limit is 31 days of refrigeration. Revaccination was offered. And proper labelling of stored vaccine as been enforced.
Severe pain on left side of neck, loss of range of motion, tight neck muscles, minor spasms in side neck muscles. Impact to daily activities and sleep. Began two days after vaccination. Did not experience with first dose. Burning sensation in left shoulder. Utilizing Ice, Heat and Tylenol. Contacted primary, then telehealth. Prescribed Diclofenac and Cyclobenzaprine. Slight Relief from symptoms but symptoms return when medicine wears off. Cannot take Cyclobenzaprine during the day. Currently 4 weeks post shot and symptoms remain.
2 days after 2nd dose of pfizer vaccine in L arm, she noticed tender L lymphadenopathy, without asosciated symptoms. She is 32 weeks pregnant.
Hives on arms and legs; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 20Feb2021 at 11:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included High Blood Pressure (HBP), Benign Prostatic Hyperplasia (BPH) and allergy to sulfa-based antibiotics. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), doxazosin mesilate (CARDURA) and doxazosin (MANUFACTURER UNKNOWN), all taken from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 30Jan2021 at 10:45 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Feb2021, two days after the second vaccination, the patient experienced hives on arms and legs, some of these were quite large (larger than a 50 cent coin). The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event hives on arms and legs was resolved on 27Feb2021.   No follow-up attempts are needed. No further information is expected.
BLOOD CLOTS; This spontaneous report received from a consumer via a company representative via social media concerned a six patients of unspecified age sex race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number and expiry date were unknown) 1 total administered on unspecified date (therapy start date and therapy end date were not provided) for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patients had blood clots. The reporter stated that "I know of 6 young healthy and all from blood clots"  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220207869-Covid-19 vaccine ad26.CoV-2.s- Blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Red and heat where: injection, given, swollen diameter of tennis ball, height 1/4-2", itched, ached, tender bruised where injection needle given, all area of swelling bruised second day, all area painful; had headache for 1 day and night and 1/2 next day
Patient received injection of Covid 19 vaccine - needle was not attached securely and vaccine ran down patients arm -patient didnot receive full dose of vaccine . Medical director for Health Dept. was on site. 2nd dose was administered after discussing with patient. Patient was monitored for 30 minutes after receiving the second dose for any adverse reactions .Patient didnot have any adverse reaction. She was called 01/19/2020 and 01/20/2020 and reported no adverse reactions.
Patient was vaccinated beyond use date of 7/6/2022. No symptoms reported by patient.
became sick; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via Digital Media through social media on 03-Dec-2020.  This case involves an adult patient who became sick, while the patient was treated with INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, past vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) at an unknown dose via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, the patient  became sick (illness) .  It was also reported that the patient was told that the vaccine did not work against all flu that was present. The patient did not get flu since.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of the reporting , event outcome was unknown .  There will be no information available on batch number for this case .
Initial report received from a healthcare professional on 22 May 2014. A five-year-old male patient, with a history of asthma, received an intramuscular left deltoid injection of INFLUENZA QUADRIVAL A-B VACCINE (lot number U4820BA) on 29 January 2014. Two days post-vaccination, on 31 January 2014, the patient developed a tic, with twitching and jerking of the arms, legs, and head. Symptoms not occur when the patient was sleeping, and worsened when the patient was tired or ill; they did not interfere with school or play. The patient was seen in the emergency room, where symptoms were documented on video. He had been seen by a neurologist and diagnosed with transient tic disorder of acute onset. Treatment included amoxicillin and ZITHROMAX with no improvement of symptoms. At the time of the report, the patient had not recovered. Documents held by sender: None.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-OCT-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23, intramuscularly, which had lot # K023328 with expiry date: 23-JUN-2016. No adverse effects reported. No further information provided. Additional information has been requested.
horrible reaction; she may not be able to live in a dorm; This case was reported by a consumer via interactive digital media and described the occurrence of adverse drug reaction in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced adverse drug reaction and activities of daily living impaired. Meningococcal B vaccine was discontinued. On an unknown date, the outcome of the adverse drug reaction and activities of daily living impaired were unknown.   It was unknown if the reporter considered the adverse drug reaction and activities of daily living impaired to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported.. The reporter stated that, after vaccination the patient had horrible reaction and might not able to lived in a dorm. and because of the reaction could be worse, the patient could not have 2nd dose of Shingrix.
Local reaction with redness to 14cm at right thigh after DTaP vaccination. Right thigh = 33cm diameter at mid circumference and left thigh = 31 cm diameter at mid circumference.
I have not had any  menstral bleeding in years.  I had the vaccine on Friday and started bleeding heavy on Tuesday. I bleed for 10 days in November.  On day 26 from first day of bleeding I began to bleed again. I bleed for 10 days in December, at which point I went to see a GYN. I had an endometrial biopsy that day and was placed on Progesterone 10 mg daily. I went back 2 weeks later for the test results, and they scheduled me for a Hysteroscopy on 2/14/2022.  On day 32 from the December bleeding, I started bleeding again this time I bled for 22 days very heavy.  I had the Hysteroscopy done on 2/14/2022 and they did not find any real reason for the bleeding. I did have a small uterine fibroid.
pt recvd vax;devel a little red knot,was raised & a warm area near inject site in the thigh;pt's MD indicated a concern about the lot number;
Statement of Incident:  A partially used vial of Moderna was returned to the refrigerator instead of being discarded on 30 Dec 2020.  On 4 Jan 2021, the partially used vial was used to vaccinate at least six patients. On 5 Jan 2021, the Immunizations Team was discussing wasted vaccines and was reminded of the 6 hour expiration timeframe once a vial is punctured.  One of the members realized that they used the above mentioned open vial on 4 Jan 2021 well beyond the 6 hour timeframe. In addition, once a vial is punctured and brought to room temperature, placing the vial back into the refrigerator will invalidate the vial and make it unusable.  Mission Impact: A minimum of six patients received invalidated vaccine. Consultation with agency concurred the doses given from this vial should be considered invalid and recommend that all patients who received vaccine from this vial be revaccinated. Corrective Action Required/Taken:  The Medical Staff and the Medical Squadron Commander were notified to report the patient safety error.  The team identified ten patients who did or possible did receive the invalid vaccine.  After consulting with Risk Management, the Healthcare Resolution Specialist and agency, all ten patients were contacted, received full disclosures, and were recommended to receive repeat Dose 1 as soon as possible.  Eight patients were revaccinated on 6 Jan 2021.  Two declined revaccination and plan to get Dose 2 as previously scheduled.  A Concise Incident Analysis (mini- Root Cause Analysis) is being conducted to determine root causes and ensure effective process improvements are implemented.
I had a headache that bothered me I mean it hurt. Then I got diarrhea, sick on the stomach and real weak and watery mouth. Just didn't feel right, feverish, real thirsty almost like the flu and my body would ache, like going up and down the hill. For a while I was really totally upset and said I shouldn't have gotten the shot. All I wanted to do was lay down and I got so weak. I don't think I would take another shot again if they come out with a booster.
Diagnosed with pericarditis. Treatment is Colchicine .6MG tab twice a day. Symptoms are Headaches, chest pain, shortness of breath, weak and low energy, tired all the time.
Received vaccine at approx 1430 on 11/6/03.  Hives noticed at 0800 11/7/03. Greatest concentration noted on extremity where vaccine administerd
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/29/2023 ACUTE PNEUMOTHORAX R09.02 HYPOXIA 3/27/2023 ACUTE PNEUMOTHORAX J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/29/2023 ACUTE PNEUMOTHORAX R09.02 HYPOXIA 3/27/2023 ACUTE PNEUMOTHORAX