chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10 doses were removed, and then the vial was placed back in the fridge.; Patient got a booster dose past 12 hour puncture/a booster dose of the Moderna Covid-19 Vaccine was given on 29Nov2021 to a patient more than 12 hours after the vial was punctured; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (10 doses were removed, and then the vial was placed back in the fridge.) and EXPIRED PRODUCT ADMINISTERED (Patient got a booster dose past 12 hour puncture/a booster dose of the Moderna Covid-19 Vaccine was given on 29Nov2021 to a patient more than 12 hours after the vial was punctured) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 022C21A and 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (10 doses were removed, and then the vial was placed back in the fridge.) and EXPIRED PRODUCT ADMINISTERED (Patient got a booster dose past 12 hour puncture/a booster dose of the Moderna Covid-19 Vaccine was given on 29Nov2021 to a patient more than 12 hours after the vial was punctured). On 29-Nov-2021, PRODUCT STORAGE ERROR (10 doses were removed, and then the vial was placed back in the fridge.) and EXPIRED PRODUCT ADMINISTERED (Patient got a booster dose past 12 hour puncture/a booster dose of the Moderna Covid-19 Vaccine was given on 29Nov2021 to a patient more than 12 hours after the vial was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took more than 12 hours after the vial was punctured. Date the vial was initially stored in the refrigerator on 17-NOV-2021. Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: Follow up received contains added reporter details( Non significant), patient initials and updated event start date( Significant information)
a child received a Pentacel vaccine, but the DTaP/ IPV liquid was not mixed with the HIB component, with no reported AE; Initial information received on 31-Mar-2021 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four-month-old (unknown gender) patient who received a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccine, but the DTAP/ IPV liquid was not mixed with the HIB component (product preparation issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 25-Mar-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ406AA, 09-Oct-2021) via an intramuscular route in the right leg for prophylactic vaccination.  It was a case of actual medication error due to inappropriate reconstitution technique (latency same day).  It was reported that, the child will be brought back in for an Act-HIB vaccine as a corrective.  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 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.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,  batch number: 1805029 and expiry: UNKNOWN) 0.5 ml, 1 total, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On 10-MAY-2021, after two months of vaccination the patient underwent a laboratory tests immunoglobulin G (IgG) and immunoglobulin M (IgM) for which reports were negative and had confirmed immunological vaccine failure. Then patient stated that his antibody was lower than normal (for a vaccinated person) and was very disappointed with it. The matter just made worse for him and he did not know what to do. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000179130 The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210520075- covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Seizure lasting less than a minute. Seizure consisted of jerking body movements, facial contorsion, eye movements. Post ictal after the episode.
Febrile seizure - diagnosed with Coxsackie virus (herpegina) on 7/24/08.
Patient experienced chest pain the day following her vaccination. She went to the emergency room and they ruled out any cardiac or serious issues.
Hives all over body, including eyes, face, neck, torso, legs, arms, palms of hands and soles of feet. Still have them as of today but symptoms are somewhat managed by antihistamines, diet, etc. Dermographia now present at random as well. Also fatigue, a blood vessel in my right eye burst (healed now), and general low energy.
Information has been received from a pharmacist concerning a 71 years old female patient. On approximately 03-AUG-2012, the patient was vaccinated with ZOSTAVAX (lot#, dose and route were not provided). No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient called the pharmacy with adverse event on 15-AUG-2012. The patient complained of numbness and tingling feet to the knees on the right leg and the foot to the hip on the left leg. No outbreaks, no rash. The patient felt nausea, vomiting, two weeks post vaccination, approximately on 17-AUG-2012 and was hospitalized. No treatment information was reported. The patient's outcome was unknown. Additional information has been requested.
after pt recv vax devel mild case 20-50 lesions on arms, back, ear, face
10-18-15/Vaccine administered, minor dizziness in the PM. 10-20-15/Major dizziness, vomiting. 10-21-15/Dizziness and vomiting continued. 10-22-15/Pain and soreness in the back of the leg, dizziness decreased. 10-24-15/Notified pharmacy - Sept patient to ER.
illness; This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   The patient's past medical history included fibromyalgia. Previously administered products included Tuberculosis vaccine with an associated reaction of malaise (received vaccine when the patient was child).   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced unwell. On an unknown date, the outcome of the unwell was recovered/resolved.   It was unknown if the reporter considered the unwell to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient for herself. The patient received the flu jab and became ill. The patient also reported that her daughter had ASD (Autism spectrum disorder) and they both had fits after the MMR (measles mumps rubella) jabs. The follow up was not required. For tolerability of the subsequent dose of influenza vaccine, refer case US2019AMR072979.
Fevers, sweating, aches- went away after two days.   Then itching without rash started, between fingers, between toes, under arms, behind knees, in private areas- anywhere "skin touches." Have tried benadryl, multiple creams, etc. No relief.
5 hrs after vaccination started "feeling sick" next am he woke up with hives on face then fever & dyspnea - hives progressed to chest - then back, arms, butt & legs approx 40hrs after vaccination hives increased in intensity 100%.
Patient is here for evaluation of a rash that started after she received immunizations at a well-child check yesterday. She is here with mom and day. They indicate that yesterday shortly after the visit she had "a few red spots", these progressed over the course of yesterday and were more prominent today. They stated she felt warm at home, but they did not take her temperature. They have tried a bit of topical hydrocortisone with minimal effect, they have not given her any antihistamines. Yesterday she received her first dose of FLUZONE, her first dose of HAVRIX, her first dose of PEDVAX, her fourth dose of PREVNAR, and  her firs dose of PROQUAD. Review of Systems -mom and dad report that since yesterday, she has been eating well, drinking well, no bowel or bladder concerns, she has continued to be normally playful. I discussed with mom and dad that the exam is most consistent with erythema multiforme, which is listed as a possible adverse reaction for PROQUAD, HAVRIX, or PREVNAR.
Patient received three vaccines then he lost consciousness, shaking and drooling.  He was sitting in the seat so I attempted to lower him to the floor and mom was holding him.  She yelled if we had smelling salt so as I cracked the ammonia salt patient had already started responding to mom.  Patient stated that he was scared of getting the shots.  Then he started to phase out again but mom yelled his name and he responded.  Oxygen started and MD notified.  Mom proceeded to inform me that this happens whenever he receives vaccines or has blood work done.  She states she forgot to let us know.  Informed her to let us know before the next vaccine so we can take him lay down for vaccines.  Oxygen saturation at 98-99% with and without the oxygen.  Pt asked for water.  Tolerated well.  Patient left walking.
One patient developed the regular mild flu-like symptoms; Patient received vaccine that may not have an extended expiration date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that may not have an extended expiration date) and INFLUENZA LIKE ILLNESS (One patient developed the regular mild flu-like symptoms) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that may not have an extended expiration date). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (One patient developed the regular mild flu-like symptoms). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that may not have an extended expiration date) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (One patient developed the regular mild flu-like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow up received and contains significant information - Event(Flu like symptoms )was updated
Information has been received from a physician concerning a 62 year old female with hypertension, arthritis, thyroid nodules and drug hypersensitivity to codeine and ULTRAM who on an undisclosed date in November 2007, was vaccinated, by her primary health care provider, with ZOSTAVAX (Oka/Merck). There was no concomitant medication. In November 2007, two days post vaccination, the patient developed hives and was treated with BENADRYL. At the time of reporting the patient still had 'a form of hives, called derma griffism. It was reported that this was hives at pressure points". At the time of reporting the patient was not yet recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Information has been received from a physician concerning a female who on 03-DEC-2007 was vaccinated with Zostavax (Oka/Merck). On 04-DEC-2007 the patient developed a "mini vzv rash" at the injection site. On 12-DEC-2007 the patient went to the physician's office. The injection site rash was red with induration over "about a 2x3 inch area" which was treated with cold compresses. Additional information has been requested.
This is a literature report for the following literature source(s): "Otologic Manifestations After COVID-19 Vaccination: Ear Clinic Experience", 2021; Vol:42, pgs:e1213-e1218, DOI:10.1097/MAO.0000000000003275. A 60 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1), for COVID-19 immunisation. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "Hearing loss". The event "hearing loss" was evaluated at the physician office visit. Information regarding lot/batch number has been requested. Sender's Comments: Based on the information in the case report, a possible causal relationship between the event deafness and suspect drug BNT162B2 cannot be excluded. The impact of this report on the 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, Ethics Committees, and Investigators, as appropriate.
12 hours after injection I was shivering freezing using multiple blankets. When I tried to walk I was very dizzy with blurred vision. I had body aches and a severe headache. My temperature was 104.7 with the thermometer. My breathing was as if I worked out but was just sleeping. I called an ambulance and was taken to health center where doctor took over care.
Patient immediately fell asleep on car ride home, upon arriving up she refused to nurse. She ran a fever and wanted to just be held and sleep. For well over a week patient screamed and cried a high pitched cry. Shortly after vaccinations while during these inconsolable fits she would bring her knees up to chest, and scream and cry so hard that she was turning bright red. Her stool was also different than normal. We worried about encephalitis and Inception.
Patient complains of radiating pain in arm had shot then sore arm. Pain went away then came back. Pain went away then came back. Patient stated she did sleep on it. Will wait 2 days before going to MD office/throbbing pain in the right shoulder and radiating it to the neck.
Patient came in for pneumococcal vaccine. Prevnar 13 was administered for first dose. Prevnar 20 was approved via cdc guidelines but not available/not in stock at time of administration.
Mom reports child had small area "whelp" on face site of immunization & was broke out more next AM.  Nurse noted several areas of erythema on abdomen, arms & legs.  Mom gave BENADRYL (84) and states area went away next day (8-5-10).
Three days p/flu shot was given, pt came down w/what was consistent w/Herpes encephalitis; Autopsy also consistent with Herpes; Does not think encephalitis was related to "flu shot";
Feeling as really bad; Malaise; Fever; Chills; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling as really bad), MALAISE (Malaise), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body ache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04AA21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced FEELING ABNORMAL (Feeling as really bad), MALAISE (Malaise), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body ache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Feeling as really bad), MALAISE (Malaise), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body ache) had not resolved.            The patient reported self-treating with ibuprofen. No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-081270.   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081270:
Symptoms began the evening of the vaccination:  Significant swelling and pain at injection site, headache, mild fever (99.3 F), muscle and joint aches.  Most concerning were areas of redness that began just below the injection site and spread down the arm to above the elbow crease.  This happened over the course of five days and covered an area of approximately 3 x 12 cm.  The affected was also sore to the touch.
Was given FLUZONE high dose 2016-17 0.5 ml SYR at 10 in the morning. About 8 hours later I started feeling very tired and had an upset stomach. Ten hours later I developed a fever of 102, headache, and some diarrhea. I slept for about 14 hours (other than trips to the bathroom). The next day I just felt washed out but the fever, nausea and diarrhea were gone. I had been given the high dose flu vaccine last year without any side effects other than some very minor soreness at the injection site. Prior to that I had received the regular dose flu vaccine for as long as I can remember without any side effects.
This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-JUN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II injection, lot # M001200 (route and site of administration, dose and expiration date were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
10 days post getting the Moderna Booster, I broke out in Dermatographia Hives all over my body that have gotten increasingly worse. I have never had allergies or skin conditions prior. I ruled out new environmental contact, lotions, foods, detergents. The only new variable in my life was the booster.
One hour after the shot I felt numbness on my left cheek as if I had been to the dentist and received a novocaine shot and its beginning to wear off but still a bit numb. Within 6 hours of the shot I had severe chills to the point I was shaking. Today, 05/19/2021, the only remaining symptom is the numbness feeling is the same in my left cheek. My smile is correct and no sagging or swelling; just the numbness feeling.
Neurologic changes- stroke like symptoms with normal EEG and imaging. Confusion, amnesia, olfactory hallucinations
I basically just had a sore throat and a lot of congestion with a low fever and body aches beginning on 05/26/2022. I was out of country at the time. I was tested for COVID-19 in order to return to the country but the test came back negative so I was allowed to return. When I returned home. I still had lingering symptoms and was noticing blood in my phlegm, so I called my primary care physician who did a telehealth examination. He diagnosed my symptoms as a sinus infection. A few weeks later, I was still dealing with some of the sinus infection like symptoms but I also began to have some very severe sciatic nerve pain, so I scheduled a doctor's appointment where they tested me again for COVID-19 and the results were positive. I had already been prescribed an antihistamine, nasal spray, and antibiotics for the previously diagnosed sinus infection, but after testing positive for COVID-19, I was prescribed prednisone and PAXLOVID. I did not take the PAXLOVID prescription. My symptoms have gotten progressively better, but I am still dealing with a lot of nasal and sinus congestion.
Patient c/o lightheadedness, dizziness & nausea about 4 hour after receiving vaccine.
Hives on bilat. arms, (L) cheek chest - CLARITIN given 15 min.
Patient complaint of itchiness in throat. Benadryl 50 mg oral given times one.  Patient verbalized she felt better after administration of medication.
throat is bleeding; the left side of inner mouth from left molar to upper left tonsil is raw; glands swelled; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL HAEMORRHAGE (throat is bleeding) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no reported medical history).   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PHARYNGEAL HAEMORRHAGE (throat is bleeding) (seriousness criterion medically significant), STOMATITIS (the left side of inner mouth from left molar to upper left tonsil is raw) and LYMPHADENOPATHY (glands swelled). At the time of the report, PHARYNGEAL HAEMORRHAGE (throat is bleeding), STOMATITIS (the left side of inner mouth from left molar to upper left tonsil is raw) and LYMPHADENOPATHY (glands swelled) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported. No treatment drug provided   Reporter did not allow further contact