chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Underdose; wrong dose was administered to the patient; This non-serious case was reported by a pharmacist and described the occurrence of underdose in a 18-year-old patient who received HBV (Engerix B) for prophylaxis.   In AUG-2023, the patient received Engerix B (unknown arm) 10 ug. In AUG-2023, an unknown time after receiving Engerix B, the patient experienced underdose (Verbatim: Underdose) and adult use of a child product (Verbatim: wrong dose was administered to the patient).  The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 25-SEP-2023 This was subsequent dose.  The pharmacist reported that the wrong dose was administered to the patient. The patient was supposed to get 3 doses of Hepatitis B vaccine. They were using an alternative dosing schedule because the patient was from a part of country with a high level of circulating Hepatitis B disease and intended to travel.  There was 20mcg given at first dose, but the next dose was only 10 mcg, which led to adult use of a child product and underdose. No harm to the patient, just reported since it did not follow the recommended dosing schedule.
Received flu vaccine - 10/12/16 - (R) arm swollen, red, warm by the evening of 10/12/16. 10/13/16 blisters on deltoid area and arm swollen down to elbow.
my whole body hurts; headache; blurry vision; Im flushed; This case was reported by a consumer and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Shingles vaccine and Influenza vaccine Quadrivalent unspecified season, the patient experienced general body pain, headache, blurred vision and flushing. On an unknown date, the outcome of the general body pain, headache, blurred vision and flushing were unknown.   It was unknown if the reporter considered the general body pain, headache, blurred vision and flushing to be related to Shingles vaccine and Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per Shingrix vaccine indication. The patient had shingles vaccine and flu vaccine at the same time.  The patient was flushed, his or her whole body hurted and had headache and blurry vision.  The patient asked did he or she need to go to the doctor.
Thursday , After getting shot, I went home.  Started feeling  warm inside, then some itchy feelings.  Headache within a couple hours . Took tylenol for the headache.  That night was very uncomfortable with fever and some ache's and hot inside and outside. by morning left side was VERY sore on arm and walnut size where shot given.  Face and eyes started swelling up , then my mouth inside and lips.  Took a couple benedryl.  Eyes were very goopy and swollen.  Took Benedryl all weekend. Still had swelling on Monday. took that day off from work also. Felt like a reaction when i have had shellfish or iodine.  If the swelling had got worse, was going to go to hospital , but the benedryl was working.  Eyes even today , goopy and itch feeling still on body....still seem more tired than usual.  some chest pains and arms on occasion.
Full body patches of hives. Roughly 40-50 days ago I had severe poison ivy on my arms. The hives are outlining the exact spot I had poison Ivy in the most interesting manner.  Hives also very prevalent on torso, inner elbows, and legs.  It seems whatever was leftover in my system from the poison ivy has reacted with the vaccine.
2 days: sore arm, fever, aches, extensive sleep days 3-10  vaccination arm swollen lymph nodes with low grade fever
HPV vaccine given as a second administration, following Menactra administration. Patient verbalized feeling dizzy as the injection was complete and thereafter, fainted and collapsed non-responsively to the floor.  No signs of breathing or alertness for approximately 15 seconds.  Numbness and tingling to extremities for 10-15 minutes thereafter.  Weakness and general malaise with upto 4 hours post admiinistration.
Site: Bruising at Injection Site-Medium, Error: Wrong Vaccine/Product Administered-
24hr p/vax temp went up to 103;pt just laid there & was listless;mom called PMD who told her to just watch pt for 24hr
Getting asthma every day; Have labor breathing/They struggle  breathing; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Getting asthma every day) and DYSPNOEA (Have labor breathing/They struggle  breathing) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033c21a and 024c21a) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included EPHEDRINE HYDROCHLORIDE, GUAIFENESIN (PRIMATENE [EPHEDRINE HYDROCHLORIDE;GUAIFENESIN]) for Asthma.   On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced ASTHMA (Getting asthma every day) and DYSPNOEA (Have labor breathing/They struggle  breathing). At the time of the report, ASTHMA (Getting asthma every day) and DYSPNOEA (Have labor breathing/They struggle  breathing) had not resolved.            Other concomitant medications included inhaler for asthma.  It was reported that patient used Primatene tablet and asthma inhaler for his adverse reactions but the pills were not working anymore.   This case was linked to MOD-2021-360771 (Patient Link).
Intense pain throughout my left arm from the shoulder through the fingers of my left hand; Tenderness in the vaccine site; Tenderness in the vaccine site andmuscle to shoulder.; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9809), via an unspecified route of administration in the left arm on 09Mar2021 at 14:00 (at the age 67-years old), as a single dose for COVID-19 immunisation. Medical history included hypertension and pre-diabetes. The patient had no known allergies to medications, food, or other products. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 17Mar2021 at 02:00, the patient experienced intense pain throughout the left arm from shoulder through the fingers of the left hand, pain lasted for 2 days and had resolved into tenderness in the vaccination site and muscle to shoulder. The events 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 events. The clinical outcome of the painful left arm was recovered on 19Mar2021 and of the vaccination site tenderness and tenderness to muscle and shoulder was recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
DREAMY STATE; MUSCLE FELT HEAVIER/FELT LIKE HUGE WEIGHT; NIGHT STRESS; LEGS FEEL STIFF; LEG SORENESS; NOT FEELING WELL; APPLICATION SITE SORENESS; NAUSEA; TIREDNESS/SLUGGISH; This spontaneous report received from a patient concerned a male 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: Unknown) dose was not reported, 1 total administered on 08-MAR-2021 05:30 on left arm for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included calcium chloride/glucose/magnesium chloride/potassium chloride/sodium chloride/sodium lactate for hydration.  On 08-MAR-2021, the patient experienced dreamy state, muscle felt heavier/felt like huge weight, night stress, legs feel stiff, leg soreness, not feeling well, application site soreness, nausea and tiredness/sluggish. On 09-MAR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg soreness, application site soreness, and tiredness/sluggish, and had not recovered from nausea, dreamy state, muscle felt heavier/felt like huge weight, legs feel stiff, not feeling well, and night stress. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Given DTaP instead of Hep A. Hep A then given to correct error.
Pt seen in ED 10/24/13 x 2 day after vaccine received. Tenderness, redness, warmth and swelling noted surrounding vaccine site. Flu like symptoms. Treated with antibiotics, antihistamine, analgesic
Information has been received from a physician concerning a 73 year old female with asthma and a history of poliomyelitis and colitis ulcerative who in March 2007, was vaccinated with a dose of Zostavax. Concomitant therapy included montelukast sodium. In April 2007, "about three weeks after vaccination", the patient experienced aches and pains in her neck, shoulders, arms and hands. At the time of report, patient's symptoms were "greatly improved". Patient was treated with Percogesic. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information has been requested.
Information has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concomitant medication, medical history and drug reactions/allergies were not reported. On 19-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # unknown, expiration date 18-NOV-2016, once) intramuscularly (expired product administered. No side effects were reported. Additional information has been requested.
Symptoms started a few hours after vaccination.  Initial symptoms were injection site pain and tiredness.  I later developed a mild headache, moderate muscle and joint pain, to which I applied a heating pad.  I then developed a low fever and chills.  Temp was 99.7 11:30pm on Feb 4, and 99.9 at 10:20 on Feb 5.  I then began to feel nauseous and generally terrible, so I went to the bathroom, where I fell and may have passed out.
Post COVID, Uriticaria/Hives/Skin Inflammation 1 week following positive Covid test
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. During 2012, the patient was inoculated (by an unspecified person) with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 24-APR-2016, he was treated (by an unspecified healthcare professional) at an immediate medical care facility for a blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles. The patient has been prescribed FAMVIR for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Hospitalized after vaccination with acute submassive PE.  ASSESSMENT / PLAN: Patient is a 53-year-old male in no significant past medical history who presented with complaints of progressively worsening shortness of breath, chest pressure and was found to have acute submassive pulmonary embolism for which he underwent successful mechanical thrombectomy per Interventional Radiology.  Subsequent bilateral lower extremity DVT ultrasound demonstrated acute DVTs in the left popliteal, posterior tibial, peroneal veins. DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute pulmonary embolism, unspecified pulmonary embolism type, unspecified whether acute cor pulmonale present (HCC) [I26.99] HOSPITAL COURSE: The patient is a 53-year-old male in no significant past medical history who is admitted for Acute Saddle Pulmonary Embolism. In the ED, the patient was tachycardic, tachypenic requiring 2 L of O2. CT angiogram thorax showed saddle embolus with extensive bilateral pulmonary emboli and evidence for right heart failure. He was immediately started on IV Heparin. PERT Team was activated and the patient underwent a successful mechanical thrombectomy with IR. Dopplers of the lower extremity showed Left lower popliteal, posterior tibial and peroneal DVTs. After 24 hours of hemodynamically stable vitals, the patient was transition to Eliquis.  The patient stay was complicated with elevated blood glucose along with Hba1c of 9.7. Endocrinology was consulted and started the patient with Lantus and LDC. The patient will be discharged with diabetic regimen and followed up with PCP/outpatient Endocrine.    The patient was stable, AOx4, without complications and discharged safely to his home with his wife.
Upper arm shoulder and eventually neck ached continuous for 1 year like when you get the flu shot. Then the spasms that lasted until 2004, Then weakness in the biceps and shoulder and neck. Now I have cramps in them so bad I have to straighten it out which hurt tremendously.
3 second long generalized tonic clonic seizure 5 minutes after MMR vaccine administered. Brought back to clinic where she vomited and had one more 3 second long generalized tonic clonic seizure. Had normal exam. No fever. Blood glucose 107. Vomited 2 additional times. Unable to tolerate po fluids.  dmitted to hospital for observation and IV fluids.
Breakthrough case admission after 2 vaccines Pfizer 3/11/21 Lot# EN6207;  Pfizer 4/1/21 Lot# ER8732
Rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age group of the patient was not reported, but selected as an adult as per vaccine indication. The caller stated that, the health care professional called her and wanted to know if a rash after the 1st dose of Shingrix was common. The health care professional stated that, he had the patient who experienced rash after vaccinaion with 1st dose of Shingrix. The reporter did not consent to follow up. The reporter did not have details about the patient or vaccine as she was not the one that gave the vaccination.
Patient began experiencing pain at injection site on 12/19/19. On 12/20/19 patient noticed redness around injection site. She has not sought out medical treatment yet.
About 1 week after vaccine, patient started experiencing pain and decreased range of motion in his left arm. Symptoms have persisted, since then with little to no benefit from OTC anti-inflammatory. Patient has only tried self medication and not seen his medical provider at this time.
Patient's mother called on 06/03/2020 at 10:26am and stated that the patient and her noticed around Noon on 06/02/2020 that he had redness and swelling on his left arm, as well as he was having pain and the skin that was red was more warm to the touch than other skin in the area. Mother stated that it had gotten worse over night and when they woke up on 06/03/2020 that he was having more pain, swelling, and spread out redness in the area which both vaccines were administered. Mother was advised to ice the area as well as to treat with Motrin as needed. Patient was seen VIA Telemedicine on 06/03/2020 by CPNP-PC to see the redness and swelling. Patient and mother were advised to continue to monitor the area, continue to move arm around, Use moist warm compresses to the left deltoid 3 times a day for 2-3 days as well as take Ibuprofen 400-600mg 4 times daily with food for 2-3 days and that we would follow up with them on Friday  06/05/2020 to see how the arm is doing and to see if the redness and swelling has went down.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Vaccine received post its 30 days Expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) 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 9:57 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 9:57 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Vaccine administration time was given as 02-Apr-2022 at 09:57:19.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
Pt became extremely warm all over as well as weak, Pt then began to get nausous as well as vomited. EMs was brought to the pts side where they gave her zofran. Pt was extremely anxious as well as stated she wasnt feeling better and wanted to be evaluated by the ER. EMS took her to the ER
Chills, Fever, Headache, Nausea, Vomiting, Dizziness. 2 hours after injection symptoms started, Lastly 12-16 hours, Patient did not report adverse reaction until today (8/13/18), before he received his third injection of the series. Patient did not receive any treatment or self-treat symptoms for adverse reaction.
Patient was administered Td vaccine on 7/30/08 and developed a local reaction of swelling, warmth and redness at injection site during the same day. Patient was seen by the doctor and prescribed steroid medication. During a follow up visit, patient completely recovered.
Patient reported sweating, coldness of hands, dizziness, blurred vision, nausea, paleness similar to symptoms of syncope but when she complained of mild pain in the left side of chest, called 911. Helped her to safety without any injury and observed until symptoms resolved in a few minutes. By the time 911 crew arrived, she was doing good and feeling much better. She did not lose consciousness at any time during the adverse event and after 911 crew arrived. she informed she does not have any chest pain and she was doing well and does not need to be referred to a hospital or her PCP. 911 crew left without any treatment. I called the patient today again at 07:45 PM and she stated she is perfectly fine.
INCORRECT PRODUCT STORAGE; THE JANSSEN COVID 19 VACCINE WAS REFROZEN AND ADMINISTERED TO PATIENT; This spontaneous report received from a health care professional concerned a 60 year old male. 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 not reported, batch number: 1821286, expiry: 20-MAR-2022) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. Age at time of vaccination 60 years old. No concomitant medications were reported.  On 08-SEP-2021, the patient experienced the janssen covid 19 vaccine was refrozen and administered to patient. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the janssen covid 19 vaccine was refrozen and administered to patient and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220540611, 20220540524, 20220540474, 20220538890, 20220541180, 20220537683, 20220538292, 20220538693, 20220537341, 20220537356, 20220537444, 20220537507, 20220537532, 20220537548, 20220538146, 20220538210, 20220538238, 20220538297, 20220538316, 20220541401, 20220541085, 20220540688, 20220540765, 20220540814, 20220540642, 20220540570, 20220540536, 20220540435, 20220540324, 20220539045, 20220537688, 20220538149, 20220538347, 20220538379, 20220538411, 20220538425, 20220538428, 20220538437, 20220538480, 20220538573, 20220538627, 20220538666, 20220538758, 20220541506 and 20220540853.
Itchy hives all over trunk of body, head but not below thighs. This is a follow-up submitted on 01/28/2010.  Rash all over body, tx with PREDNISONE 20 mg  taper x9d.
I received my booster shot (3rd in total) of the Pfizer COVID-19 vaccine and the next morning I noticed that my left armpit was in pain. I received my shot on my left arm and believe my lymph node in the area of my left armpit was swollen. It was a dull pain that hurt more with any activity and lasted for a total of 8 days. I had no residual effects after 8 days.
Headache, muscle aches, fever, fast heartbeat, dizzines and weakness in the first day.  the following days I have felt like when asthma starts, and I get tired quickly
Patient had tightening of the throat and was treated with 25mg oral Benadryl. Issue resolved in thirty minutes.
Fever, body aches all over within 24 hours.  Then reddened, swollen right upper arm.  Right lymph nodes in Right arm pit also swollen, painful.
Information has been received from a nurse practitioner concerning a 10-12 years old female patient who on an unspecified date was vaccinated with GARDASIL (lot # not reported). In January 2009 ("2 years ago"), the patient experienced systemic reaction. The vaccination with GARDASIL was discontinued and not reintroduced. Subsequently, the patient recovered from systemic reaction. Systemic reaction was considered to be immediately life-threatening by the reporter. Additional information has been requested.