chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diagnosed with Shingles; This case was reported by a consumer and described the occurrence of shingles in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included nonsmoker.   In 2019, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 57 or 58 years. The patient's blood type was O positive, body mass index was 24 and was active type. The patient was vaccinated last year and two weeks later was diagnosed with Shingles. The patient's yearly physical was due again. The patient was not sure if he should try the vaccine again as it seemed risky for his blood chemistry make up.
Elevated temp, body aches, headache, rash, fatigue, sore arm. Lasted 36 hours.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. 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 administration not reported, batch number: 204B21A, and expiry: unknown) dose was not reported, 1 total, administered to the left arm on unspecified date SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-JAN-2022, the patient started having fever, sore throat, congestion and headaches (suspected covid-19 infection). On 30-JAN-2022, covid-19 Home test was positive (suspected clinical vaccination failure). The patient recovered from fever, sore throat, congestion and headaches on 03-FEB-2022. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000221157.; Sender's Comments: V0: 20220319142-Covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure . 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. Therefore, this event(s) is considered not related.
Mild facial flushing, lip tingling, tightness in forehead within 10 minutes of injection;  providers checked pulse/ox and BP9BP 140/90 which is higher than normal).  Symptoms subsided within 25 minutes, but recurred less acutely more than twelve hours later after use of Travaprost eyedrops, then Dorzolamide Timelol drops.  Symptoms subsided again within half an hour afterward.
received only the adjuvant; received only the adjuvant; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number H54CA, expiry date 18th May 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The reporter reported that 6 patients were administered Shingrix from 28th January 2022 and 2nd March 2022 and one of them received only the adjuvant, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. For 5 of the 6 patients, this would had been the patients' second dose. For one patient, it would had been their first dose. 1 of 6 patient had possible adverse events. The reported lot number was for the powder component.  HCP did not have lot for adjuvant. Consented to follow up was provided. The reporter stated that out of 6 patients only 1 experienced the medication error, but the reporter was not certain which of the patients experienced it. Therefore, 1 case would be considered as valid (US2022042592) while the other 5 would be kept invalid.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022042597:Same reporter US-GLAXOSMITHKLINE-US2022042594:Same reporter US-GLAXOSMITHKLINE-US2022042599:Same reporter US-GLAXOSMITHKLINE-US2022042600:Same reporter US-GLAXOSMITHKLINE-US2022042601:Same reporter
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; Product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (Product storage error) 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)) (batch no. AS7140C) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and PRODUCT STORAGE ERROR (Product storage error).    It was reported that 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion. This case is for thirty three patient out of 77 patients reported. No concomitant medication information provided. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Pt received Pfizer Vaccine on 1/27/2021. Pt was admitted on 2/14/2021 for UTI, abdominal wound drainage (recent hernia repair). Not thought to be related to vaccine. Due to EUA of vaccine, "inpatient hospitalization" requires VAERS reporting.
This is a 57y.o. female with a past medical history of asthma, paroxsymal atrial fibrillation, TIA, and cardiomyopathy. Presenting to the emergency department for Corona virus concern.   Patient states that this past Tuesday 12/28/21 she went to get COVID-19 (test resulted 2 days later as negative) as a part of her job requirement. She had no symptoms at that time blood testing was initiated at work. She states later that day she started to feel sick and started throwing up, she described nausea and nonbloody emesis. She states as the week went on she couldn't take down any liquids besides water and has not eaten since Tuesday. Since she was unable to keep down any sort of solutes she was unable to take her medications since Tuesday including her blood thinners as well as her cardiac medications. She describes no episodes of shortness of breath and has not used her albuterol inhaler all week. She states someone she was in contact with someone who was positive for COVID-19. Patient was vaccinated ×2 with the Moderna vaccine back in April of this year, not yet had the booster   Patient denies any sort of chest discomfort. Patient does endorse chronic back pain as well as left leg pain worse than right leg pain that started ever since she was vaccinated back in April of this year. Recent states she last saw Dr.  in his office the week prior. Upon review of social history patient endorses daily marijuana smoking as well as 3-4 cigarettes daily. Patient drinks 2 alcoholic beverages every Sunday. Patient has not had a bowel movement since sometime last week.
Arm pain - extreme. I couldn't fully move my arm which lasted 24 hours. And then it lessened so I could use it but still pain for three or four days. Redness on injection site - just a big, red spot (not rash). Red spot went away and then a big white spot - six days for white spots. Almost like my arm wasn't getting blood - just white like that for a few days. Headache - still have it - minor enough when I wake up but when I go to bed that every other day I'm still taking medicine for it; nausea; fever; chills; hot flashes - lasted 5 or six days; fatigue - still have a little fatigue. It is better than it was. At first I was sleeping 15-16 hours a day. Still have to go to bed earlier than normal. Stomach pain - those are gone now; runny nose; loss of appetite; brain fog - I knew what I wanted to say or do but couldn't. Advil was taken and I tried Tylenol, too. I iced my arm. I did a humidifier.
12SEP95 MMR given; 14SEP95 swollen cervical lymph nodes, sore throat, fatigue, myalgias, low grade fever through 20SEP95; inj site w/rash several inches distally 14SEP quarter size 20SEP95
Child has redness and warmth to right upper arm 09/18/2001. Saw MD 09/20/2001, fever 100, redness and warmth to right arm from shoulder to elbow and extending onto chest. Given Benadryl by MD to return to MD for recheck.
The day after the 1st shot I was experiencing brain fog (memory problems, delayed recall, trouble focusing). After 3-4 days it improved, but didn't completely clear up. I'm still having the same issues. The symptoms aren't as bad as immediately after vaccination, troubling though.
they were sick to their stomach; uncontrollable diarrhea; chills; their arm was sore; threw up last night; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (they were sick to their stomach), DIARRHOEA (uncontrollable diarrhea), CHILLS (chills), VACCINATION SITE PAIN (their arm was sore) and VOMITING (threw up last night) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, the patient experienced ABDOMINAL DISCOMFORT (they were sick to their stomach), DIARRHOEA (uncontrollable diarrhea), CHILLS (chills), VACCINATION SITE PAIN (their arm was sore) and VOMITING (threw up last night). At the time of the report, ABDOMINAL DISCOMFORT (they were sick to their stomach), DIARRHOEA (uncontrollable diarrhea), CHILLS (chills), VACCINATION SITE PAIN (their arm was sore) and VOMITING (threw up last night) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2021-378313 (Patient Link).
pt vax hepta B. pt ex n/v light headedness and increase in blood pressure 30 min aft dose. sx remitted. no addit doses.
pt recvd vax 25FEB92 & on 7MAY92 pt recvd 2nd dose of vax & 12NOV92 pt seen due to a fever; blood cult grew Haemophilus influenza, type B; 15NOV92 hospitalized & cultures of CSF fluid also grew Haemophilus influenza, type B;
Hives - started 10/29/03 lasted 2 weeks. Shot given 10/27/03. Steroids administered - pill form and Benadryl. Inside throat swollen.
Cellulitis; Heat from injection site; Swelling; became red; Injection site pain; A spontaneous report was received from a Consumer concerning a 37-years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Erythema, Injection site warmth, Swelling, Cellulitis and Injection site pain.  The patient's medical history was not provided.  Relevant concomitant medications were reported as Monopost, Multivitamins, Lisinopril.  On 29 DEC 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced Erythema, Injection site joint discomfort, Swelling, Cellulitis.   On 29 DEC 2020, the patient experienced Injection site pain. His arm began to hurt the day of injection and continued for about a week after the injection. Arm pain began to subside for a day or two. After a few days arm swelled again and became red or started generating heat. Patient went to the Emergency Room for treatment and was diagnosed with Cellulitis.   No Laboratory details were provided.  Treatment information was provided as Tylenol and Antibiotics.  Action taken with mRNA-1273 in response to the events was unknown.   On an unknown date, the outcome of the events was recovered.; Reporter's Comments: This case concerns a 37-year-old male who experienced serious unexpected cellulitis, serious expected swelling, NS unexpected injection site warmth and NS expected injection site pain and erythema.  Event onset was the same day as the first dose of mRNA-1273. Treatment with Tylenol and antibiotics. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
pt recv vax 18DEC95 & 5FEB96 lab eval revealed varicella antibody 0.85;
Deltoid, coracobrachialis and biceps pain, constant, throbbing or shooting when moving the arm. Motion range reduced. Difficulty raising, using the arm without pain. Pain killers are ineffective.
patient began to experience dizziness, palpations, fever up to 103, chills, and shortness of breath, nausea and vomiting, tachycardia as well as became delirious about 45 minutes after receiving the Meningococcal B vaccine.
This spontaneous case was reported by a dietician and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccine site look too low/Appears it is outside of the deltoid area) and NO ADVERSE EVENT (No adverse event) in a 6-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccine site look too low/Appears it is outside of the deltoid area) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccine site look too low/Appears it is outside of the deltoid area) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccine site look too low/Appears it is outside of the deltoid area). No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.
Within 10 minutes I was dizzy and had a foggy mind, I was having a hard time catching my breath. They gave me a large dose of liquid Benadryl. My vitals were fine. In 5-10 minutes I wasn?t heavy breathing but still slightly dizzy.  I went home, slept off the Benadryl and was tired but fine the rest of the day.
Developed rash after few days post injection around injection site, the rash has subsequently spread and is still present. It consists of multiple "spots" pustules in various stages of healing.
cousin died unexpectedly; This spontaneous case was reported by an other health care professional and describes the occurrence of DEATH (cousin died unexpectedly) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 07-Dec-2021 The patient died on 07-Dec-2021. The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment medications was not reported Unknown primary series when agent asked. Caller could not confirm if cousin had Moderna or not for primary series. Caller knew her cousin was 50 years old but DOB she did not know and states she was not pregnant  Company comment: This case concerns a 50 year old female patient with no reported medical history, who experienced the serious unexpected event of Death, 6 days after receiving the third (booster) dose of mRNA 1273 Covid-19 vaccine. It is unknown if patient received mRNA 1273 vaccine for the primary series. Patient died unexpectedly and cause of death is unknown. It is unkown if an autopsy was performed.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 50 year old female patient with no reported medical history, who experienced the serious unexpected event of Death, 6 days after receiving the third (booster) dose of mRNA 1273 Covid-19 vaccine. It is unknown if patient received mRNA 1273 vaccine for the primary series. Patient died unexpectedly and cause of death is unknown. It is unkown if an autopsy was performed.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Reported Cause(s) of Death: unknown cause of death
9/23/23 Resident reports feeling unwell, general fatigue, body aches and nasal congestion.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 22-APR-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL (strength: 0.5 ml) lot # L020162 and expiration date: 23-JUL-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 120 hours, with the highest recorded temperature of 53 degrees Fahrenheit (11.66 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
really cold; a little clear liquid filled blister where he got the vaccine; fever; shivering a lot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASOPHARYNGITIS (really cold), VACCINATION SITE VESICLES (a little clear liquid filled blister where he got the vaccine), PYREXIA (fever) and CHILLS (shivering a lot) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     No medical history was reported.     On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced NASOPHARYNGITIS (really cold), VACCINATION SITE VESICLES (a little clear liquid filled blister where he got the vaccine), PYREXIA (fever) and CHILLS (shivering a lot). The patient was treated with PARACETAMOL (TYLENOL) on 26-Mar-2021 for Fever, at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (really cold), VACCINATION SITE VESICLES (a little clear liquid filled blister where he got the vaccine), PYREXIA (fever) and CHILLS (shivering a lot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication information was provided
Within 12 minutes from vaccine I went from fine to my tongue starting to not feel right. I could feel one side of my tongue but couldn't feel the other side. My lip started to droop on that side too. My mom drove me and she looked at me and said that my left side of face was drooping downward. I was trying to talk but I couldn't, and it felt like all nerves on left side of face were gone. It went from that into my arm. I had a drink of water and I dropped the bottled water and it just fell. I couldn't even feel it. The doctor came over and checked and said that it's a response that he has seen before. It started in my tongue, mouth, lips, and above my  lip, and it was just heavy and I felt no nerves. It took me about an hour and they gave me some Benadryl and relaxed a little bit. One area would wake up and work and then another section wouldn't work. I felt like a broken circuit board and my brain went whacko on the left side. That lasted about an hour. My forearms broke out in a rash (both arms) and I still, on my arms, now have darker pigmented area and it's just a little bit oval shaped on both forearms and the top is darker. When it happened at first, it was red. The next day I started having really bad COVID symptoms, I couldn't taste anything, I could barely get up, I was sleeping a lot and this went on for about a week. The brain fog was really bad and I couldn't come up with words or visualize places I've been many times or even think about the inside of something. It was like the visualization was affected. There was a heaviness in my head, like something was squeezing. It wasn't a headache or sinus pressure it was just encompassing pressure on my head. If I get run down I have this happen. I lost taste, can't think right, sleep, and I call it my bad days. When it lifts, it just goes away, but it feels like pressure around my head in brain. I have hand numbing in both of my hands, and I thought I had carpal tunnel, and that's an on and off thing and that feels like its asleep and you shake it off and it wakes up, but I find it worse during my bad days. I had some missed periods, very scattered periods, which is unusual for me because I have endometriosis and they are usually heavy, and it was skipping and then having a heavy day and then nothing. I called my doctor one day because I felt like a surging circuit board and was wired, couldn't sleep and everything was intense and felt like I was drugged. I went in either the next day or two days later and at this point it settled down and I told her what was happening and she thought I had long haulers syndrome but I was feeling fine for months after having covid but the vaccine thing is what I'm struggling with and it triggered everything and won't go away. I saw her at least twice and I go back in November. I wonder what things would be like if I  went to the doctor when I was feeling bad and when it was happening. I can say that upping my magnesium and focusing on foods with potassium gives me better brain clarity and I snap out of things a lot better so that helps.
Vertigo. Nausea. Dizziness. Headache. On and off for 3 days. Still having symptoms .