chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After sitting down in the observation area, pt reports feeling extremely warm, diaphoretic, anxious, and had tinittis. Pt denied trouble speaking, swallowing, breathing, etc. He denied pruritis. We layed pt down and instructed him to rise slowly when he felt comfortable. He was given an ice pack and juice and crackers. Pt felt okay when he left.
Patient in observation area, unresponsive to verbal commands, elevated heartrate (120-140), elevated bp 180's-210/100-105, tachypnea (20-26), normal O2 sat (99-100%). EMS activated. Shaking extremities, able to move all extremities on command. No diaphoresis.  At 10 minutes more alert and c/o chest pain 8/10. Transported by EMS to ER.
This prospective pregnancy case was reported by a healthcare professional (nurse) and described the occurrence of vaccine exposure during pregnancy in a 34-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included pregnancy. The subject had one previous full-term pregnancy; however, details regarding the outcome were not reported. The subject was not using contraception and the type of conception was normal. There was no evidence of defect from prenatal testing. Maternal and paternal history which may have an impact on the outcome of this pregnancy was unknown. In 2013 the subject received a dose of FLULAVAL (.5 cc, unknown route, left deltoid) and experienced vaccine exposure during an unknown trimester of pregnancy. The gestational age and date of last menstrual period were not reported. The estimated date of delivery was reported as 1 November 2013. On an unknown date, the subject had an ultrasound examination with result of no evidence of defect from prenatal testing. At the time of reporting, the pregnancy was ongoing. The nurse reported another case with FLULAVAL. See case A1046739A for details on the other case. 11March2014: No further information provided; patient lost to follow-up. Follow-up information was received on 08 April 2014 via nurse. Concurrent medical conditions included blood pressure, depression and gastrointestinal disorder. Concurrent medications included PREVACID, TOPROL XL, ZOLOFT, prenatal vitamin, PRISTIQ. The pregnancy was by normal conception. At 39 weeks gestation age, the subject gave birth to a male live infant who was considered full term. The infant was delivered by cesarean section, weight 7 pounds 11 ounces, 19 1/2 inches in length. Head circumference and Apgar score were not provided, the report stated the mother said "he was perfect".
Patient was administered Bexsero instead of Menveo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number XX33P, expiry date 31-JAN-2026) for prophylaxis.   On 06-MAY-2023, the patient received Bexsero. On 06-MAY-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Patient was administered Bexsero instead of Menveo). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-MAY-2023 The registered pharmacist reported that a patient was administered Bexsero on Saturday instead of Menveo.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient received Bexsero instead of Menveo, which led to wrong vaccine administered.
2nd dose 5 weeks after the first; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The case was self-reported by patient. The age at vaccination was not reported. The patient received 2nd dose 5 weeks after the first dose earlier than the recommended interval, which led to shortening of vaccine schedule. The patient enquired was that okay.
Anosmia.  A lot of things smelled like rotted flesh.  It started gradually after a couple of months (exact date not known), peaked at about 3 months, then slowly dissipated.  It was barely noticeable.  Then on 9/30/2021 I noticed it came back extremely strong, and it wasn't just some things as before, it was everything.  I suspected that this was actual COVID-19, and on 10/1/2021 I got a rapid and a PCR test and tested positive.  The anosmia was almost intolerable this time.  As of 10/14/2021 it is still constant, but no longer smells like rotted flesh, it is more of a sickly sweet smell.
Very red throat; Feeling Bad; Immune related; Sick for a month; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL ERYTHEMA (Very red throat), FEELING ABNORMAL (Feeling Bad), ILLNESS (Sick for a month) and IMMUNE-MEDIATED ADVERSE REACTION (Immune related) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ XR) for an unknown indication.    Concurrent medical conditions included Drug allergy (ORENCIA), Drug allergy (HUMIRA) and Drug allergy (CIMZIA (Xeljanz XR) ).   On 28-May-2021, the patient started TOFACITINIB CITRATE (XELJANZ XR) (Oral) 11 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ILLNESS (Sick for a month). In September 2021, the patient experienced IMMUNE-MEDIATED ADVERSE REACTION (Immune related). On an unknown date, the patient experienced PHARYNGEAL ERYTHEMA (Very red throat) and FEELING ABNORMAL (Feeling Bad). In 2021, ILLNESS (Sick for a month) had resolved. In September 2021, IMMUNE-MEDIATED ADVERSE REACTION (Immune related) had resolved. At the time of the report, PHARYNGEAL ERYTHEMA (Very red throat) and FEELING ABNORMAL (Feeling Bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other medication included Atorvastatin, Metoprolol, Prozac, Calcium+D, Gabapentin, Hydrochlorothiazide, Xarelto and Omeprazole. Patient stated that she was off XELJANZ XR for the whole month of September 2021 due to having a really bad time with the covid shot (moderna). No other treatment medication was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Information has been received from a registered nurse concerning an 11 year old female who on 10/14/99 was vaccinated with a dose of varicella virus vaccine live (lot # 631524/1012J). On 8/13/04 the patient developed a chicken pox rash that was noted to be on her abdomen and spread to her armpits. Her rash was also described as erythematous, papules, and some vesicles. At the time of the report, there was no specific treatment necessary. Unspecified medical attention was sought. There was no product quality complaint. It was also noted that the patient's sister was vaccinated with varicella virus vaccine live and developed chicken pox (WAES0408USA01569). Additional information has been requested.
pins and needles in legs; lips started to swell; throat became a little swollen; face swelling; couldn't eat for two days; nauseated; chills; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (pins and needles in legs), LIP SWELLING (lips started to swell), PHARYNGEAL SWELLING (throat became a little swollen), SWELLING FACE (face swelling) and FEEDING DISORDER (couldn't eat for two days) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced PARAESTHESIA (pins and needles in legs), LIP SWELLING (lips started to swell), PHARYNGEAL SWELLING (throat became a little swollen), SWELLING FACE (face swelling), FEEDING DISORDER (couldn't eat for two days), NAUSEA (nauseated), CHILLS (chills) and MYALGIA (muscle aches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 25-Jan-2021, PARAESTHESIA (pins and needles in legs), LIP SWELLING (lips started to swell), PHARYNGEAL SWELLING (throat became a little swollen), SWELLING FACE (face swelling), FEEDING DISORDER (couldn't eat for two days), NAUSEA (nauseated), CHILLS (chills) and MYALGIA (muscle aches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication include birth control and steroids.  Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up contains Concomitant details was updated, second dose details updated.
I got both of mine painful but not as painful as the Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: I got both of mine painful but not as painful as the Shingles).  The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-AUG-2023 The case was received from the patient via interactive digital media. The patient received both her Shingrix vaccine which was painful. It was not as painful as Shingles. She stated that the people she knew had shingles were like it was so painful. The patient asked to get vaccinated.  The follow-up would not required per process
I had chills, a slight fever, grogginess and muscle pain in the arm I received the injection within the 1st 18-24hrs . I took Tylenol and that helped with the muscle pain and chills.  At about the 28th hour pain on the injection side of my body increased. My lymph nodes started to hurt in the neck and collar bone. By the next morning, my whole left side of my body was inflamed, the lymph nodes in neck, collar bone and armpit were visibly swollen and the pain at the injection site was severe. I did not go to work due to the pain. This lasted 24 hrs, them ceased. Tylenol was only marginally effective.
MIS in an adult patient; This is a literature report. An adult patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine) (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: 01, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS (medically significant), outcome "unknown", described as "MIS in an adult patient". There are no prior reports of MIS-C among patients who have been fully vaccinated, and only a single case of MIS in an adult patient who had received his second shot just 4 days prior to symptom onset.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the event of MIS 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.
Blurry vision again after booster dose/vision has changed again; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VISION BLURRED (Blurry vision again after booster dose/vision has changed again) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 003B21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (Blurry vision again after booster dose/vision has changed again). At the time of the report, VISION BLURRED (Blurry vision again after booster dose/vision has changed again) had not resolved.            Patient uses concomitant medication but no relevant concomitant medications were reported.  Treatment information included patient got new eyeglasses made after checkup.   This case was linked to MOD-2021-396185 (Patient Link).
Received MMR/Varicella by pediatrician 7/22/02. Then visited my ER 8/3 with a red rash onset 8/1/02 that may be consistent with rubella or measles.
Severe pain in hip where he had a partial hip replacement.  His blood pressure was extremely high from the pain.  I thought he had broken his hip so I took him to the Orthopedic doctor who x-rayed the hip and said that there was arthritis flaring up causing this problem.  A few days later, the pain was gone but he had developed a problem swallowing and aspirated leading to pneumonia.  Even after the pneumonia was resolved, he was unable to drink or eat.  He was placed on a diet with mush and honey liquid and died a week later.
The pt broke out in hives around the injection site and then all over the body. The pt also experienced an erythematous urticarial lesion.
The patient waited in the clinic for 15 mins after the injection, with no side effects. We were notified that she was at clinical in a neighboring town and went unconscious. CPR was performed, and she was shocked and was able to return her heart beat. She was transferred to a bigger facility where she coded again and subsequently passed away. The family is under the impression she had a COVID vaccine but that was not given in our clinic. A friend, who she attended nursing school stated that she knew patient was getting an HPV vaccine as she told her that day but said nothing about the COVID vaccine.
Muscle pain. Feeling tired or weak. Headache. Shivering. Fever. Upset stomach or throwing up. Stomach pain or diarrhea. Fever of 105F.  Lasted 24+ hours
5x6 cm in diameter, erythematous patch warm to touch at injection site left deltoid.
Patient communicated that she had been hospitalized for 3 days following her vaccine #2. She awoke with fever, chills and collapsed. Says had incontinence of bowels and bladder and was in Atrial Fibrillation on EMS arrival.
Patient was sitting in the waiting room and started to feel jittery. Patient's lips were chattering and his arms were jittery. I brought him back to the clinic room and took his BP and pulse. He started to feel some better. He sat back out in the waiting room for an additional 15 minutes.
20JUL92 in evening was gasping; 21JUL92 t105 seen in ER; 23JUL92 DNKA w/MD mom states that pt was fine by 23rd;
Information has been received from a pharmacist concerning a patient who was vaccinated with pneuumococcal 23v polysaccharide vaccine. Subsequently the patient developed  fever, body aches, flu-like symptoms and large local reaction described as a reaction from the injection site to the elbow. The patient sought unspecified medical attention. No additional information was  provided.
member was vaccinated on 12/29 - 1-2 hours later developed injection site soreness/swelling/chills/fatigue/intermittent headaches/"head cold like symptoms" - yesterday evening developed R facial swelling including to upper lip and numbness in face - is able to smile and use muscles normally no facial dropping but face is still puffy today after 50 mg Benadryl.  Member has R inner ear itching but denies throat tightness/difficulty breathing
Case number PHEH2014US021207 is an initial spontaneous report received from a nurse on 20 Oct 2014. This case refers to a 43-years-old male patient. past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: not reported), intramuscularly on 13 Oct 2014, which had reached room temperature for four days. no adverse event was reported following this administration error (incorrect storage of drug).
mom states pt cried constantly for more than 3hrs;mom was so concerned she took pt to ER-however nothing was done @ ER x/recommend APAP
PM or 2-15-12 (L) deltoid painful. 2-16-12 PM (L) deltoid very red, swollen & red streaks radiating to (L) armpit, (L) deltoid painful.
Day 8 after receiving the vaccine a welt started growing on the employee's arm, then it progressed to swollen lymph nodes, a rash, chills and joint pain. No fever and no shortness of breath.
Pt received vaccine - meningococcal - 8/20/10. Pt presented to UC 8/21 with ascending paresthesias and weakness. Sent to ER, hospitalized in ICU x 24 hours. Symptoms resolved without intervention and pt sent home 8/23/10.
sore throat (has improved), cough, nonproductive cough, chills, sinus congestion (Improving), nasal congestion, post nasal drainage, some pain in ribs. starting  1/12/2022
21 days after below immunizations had febrile seizure x2 seen at local ER sent home. Later had second seizure and admitted to hospital. See attached.  Child admitted 5/5-8/2007 for c/o seizure activity.  On the day prior to admission child had a 3-4 minute generalized tonic-clonic seizure.  Seen in ER and DXd with pneumonia and DCd after 12 hours.  Fever spiked that pm and child seized again lasting ~8 min. during which he developed circumoral cyanosis.  Mom gave rescue breaths, but child remained very sleepy in post-ictal state. He was admitted directly after 2nd seizure. PE:  WNL. Assessment:  Febrile Seizures with fever of unknown source.
From 11/16/21 appt: Pt has had full body itchiness which began 9 days after getting the covid vaccine, she is having to take benadryl to be able to relax enough to go to sleep, Pt says its worse at night. No new soaps, foods, detergents, lotions, toothpaste. Not out gardening. No bug bites. No increased stress. Any friction against skin and it'll get red and swollen/hive. red flush goes up her body. began about 9 days ago. Had booster 9 days before the itching. Used biofreeze and it helps some and ice packs. Benadryl helps but can't use during day because she's too tired. Nothing new that she's in contact with. Stopped her medications to see if that would help but no help as she had been diagnosed by dermatologist with acne, tinea versicolor and raynaud's and was taking medication for it. She was working in nursery with a child who had a bad diaper rash. She checked skin for signs of scabies and didn't see any. She can't think of anything else that could have caused it. Her vitamin does have niacin in it.  We treated her with steroid dose pack as well as Allegra as she had a rash which was felt to be hives /allergic dermatitis 6/16/22 appt: She continued to break out in hives whenever she got hot. It is very itchy. She also experienced a histamine release type of flush whenever her core would get hot. She was seen by the dermatologist who diagnosed it as a cholinergic urticaria. She continues to take allegra and it's not as bad if she keeps core cool.
Pt experienced sever headache, loss of speech transported to Medical Center. 4/19/21 Reports overnight stay and "blood clots" affecting speech, causing HA. Reports clots seen around his heart on MRI  Discharged 4/20/21
Pfzer-BioNTech Covie19 Vaccine EUA.  Joint and muscle pain in neck, shoulders, lower back, buttocks, legs.
The neighbor had a lump in her armpit after the 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MASS (The neighbor had a lump in her armpit after the 1st dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MASS (The neighbor had a lump in her armpit after the 1st dose). At the time of the report, MASS (The neighbor had a lump in her armpit after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milligram. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live significant Follow-up appended: Patient details (age group) was added..
ZOSTAVAX administered 7/2/12. Pt complained of arm pain 3 days later. Pt met with PCP Dr. to received treatment for pain. I received call today (7/21/12) informing me.