chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Jannsen Vaccine on 4/01/2021 and 3/23/2021. Presented to facility of 8/28/2021 with a chief complaint of cough without SOB, with room sats of 85%,  fever, and COVID positive. Patient required intubation on 8/30/2021 during a cardiac arrest. On 8/31/2021 patient transferred to facility. On arrival with air transport, patient is hemodynamically stable, sedated on propofol.  Patient is connected to MV with settings CMV 20/450/.70 +10. On 9/2/2021, spontaneous movement but not following commands.  Remains in prone position.  HD yesterday.
This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 24Mar2021 at 10:30 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included birth control medications, herbal and dietary supplements; all for unknown indications from unknown date. The patient previously received tetracycline and experienced allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 24Mar2021 at 11:00, the patient experienced some headache and in night, the patient's upper arm and surrounding area was sore. On 25Mar2021, the day after the vaccination, the patient's arm was bit swollen and she had chills but doesn't show up as a fever. The patient reported that she did not seem to have headaches but felt that she was on a verge of getting a fever. The patient did not receive any treatment for the reported events. The events did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events headache, upper arm and surrounding area was sore, swollen arm and chills were resolving. No follow-up attempts are possible. No further information is expected.
Great pain in upper left arm area up to base of neck. Unable to sleep on left side. Only getting about 4 hours of sleep at night because of pain. Unable to lift left arm past shoulder.
Pt came in to receive a Janssen vaccine (1st dose). The presented calm and nothing of concern was noted on pt intake form, including no history of reaction to vaccines. After the injection the pt began to get pale and asked for a cup of water. He then passed out for ~10-15 seconds. After he woke up he appeared pale and was dizzy. No swelling was noted or redness at injection site. Pt was not having any signs of breathing distress. ~3-5 min later he passed out again and started snorting and lips were tinged blue. An epipen was then administered and 911 was called. He came back to after  ~15 seconds. Pt still appeared pale and dizzy. EMS arrived shortly after and monitored the pt for ~15 min afterward he was released. Pt wife stated (after she arrived after EMS) that pt had a history of passing out during blood donations. Reaction suspected due to pt's apprehension to getting the vaccine
headache, high fever, loss of apetite; vomiting on the 25th, along with high fever, loss of apetite.
This spontaneous report was received from a registered pharmacist refers to a 52 years old female patient who on 16-JUL-2012 was vaccinated SC with 0.65 ml of a dose of ZOSTAVAX into the left arm (lot number reported as 0365AE). No other co-suspects were reported. No concomitant medications were reported. On 18-JUL-2012, the patient presented to pharmacy and had red area around the injection site of the left arm. Also, it was reported that the injection site was warm to the touch and no rash was presented. No treatment was given for the adverse event. The patient sought unspecified medical attention by a pharmacy visit. At the time of the report, the patient had not recovered. The relatedness for red area around the injection site and injection site was warm to the touch is unknown for ZOSTAVAX. Additional information has been requested.
Off and on fever till next day. Sleeping patterns were light and was very fussy, just seemed like he did not feel well. Per Dr office we let it run it's course.
Was due for his second dose of Moderna. This nurse was giving moderna and pfizer and accidentally gave patient a Pfizer vaccination. No adverse reactions or side effects were noted during the 15 minute monitoring after injection.
Pt recvd 2nd dose of vax & exp diabetic ketoacidosis & also dehydration leading to memory loss; seen by MD; hospitalized in ICU for 6 days; hospitalized a total number of 28 days; pt memory lost persists;
Nauseated, elevated HR, resolved after drinking water and waiting. Evaluated by EMS-Cleared
Nausea, dry heaving, interrupted sleep then on 11/04/2013 sneezing and runny nose.
13 doses administered 25-Oct-2021, this lot number has an expiration date of 24-Oct-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13 doses administered 25-Oct-2021, this lot number has an expiration date of 24-Oct-2021) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (13 doses administered 25-Oct-2021, this lot number has an expiration date of 24-Oct-2021). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (13 doses administered 25-Oct-2021, this lot number has an expiration date of 24-Oct-2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was given by reporter. No treatment medication was given by reporter   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received on 29-Oct-2021 contains No new information.
Information has been received from a nurse referring to an unspecified number of patients with unknown age and gender. On unknown dates the patients were vaccinated with improper stored oral, ROTATEQ (lot # K023532, expiration date 21-JUN-2016) (dose and route were not reported) by an unspecified physician. No adverse effects reported. This is one of several reprots received from the same reporter. Additional information has been requested.
A report has been received from a Health Professional concerning a 5 year old, female patient, who had been receiving FLUMIST Quadrivalent (intranasal). FLUMIST Quadrivalent started on an unknown date. It was reported that the patient received an expired dose of FLUMIST from Jan2015. And also reported product quality issue. The outcome of the event of received an expired dose and product quality issue was unknown. The report was considered to be non-serious.
Death - caused by acute gastrointestinal bleed, hemorrhagic shock, multiorgan system failure, and cirrhosis of the liver
Information has been received concerning a less than 2 year old female who on an unspecified date was vaccinated with a dose of MMR (second generation). Concomitant therapy, that same day, included a dose of poliovirus vaccine (IPOL) and a dose of diphtheria toxoid/pertussis vaccine/tetanus toxoid (INFANRIX). Subsequently, at an unspecified time post-vaccination, the patient developed erythema multiforme. The reporting pharmacist was not sure if the erythema multiforme was caused by diphtheria toxoid/pertussis vaccine/tetanus toxoid (INFANRIX) or MMR (second generation). As of 10/4/02, the event was worse. Erythema multiforme was considered medically serious (OMIC). Therefore erythema multiforme was considered to be an other important medical event. This was originally reported by a pharmacist. Upon follow up, the pharmacist reported that the information was reported from on of the clinic sites. No additional information was received. This is a consolidation of two reports containing the same patient. Additional information is not expected.
Itching in arm around injection site started on day 4 and has continued until today which is day 14
pt recvd vax in NOV93 & FEB94 pt devel upper resp sx & was treated w/Pediazole; Pediazole was was discontinued & 3 days later 24FEB94 pt devel a fever & enlarged occipital nodes; 25FEB94 pt devel a rash on face, neck & trunk;
Information was received from a nurse practitioner referring to a 2 month old patient of unknown gender. There was no information about the patient's medical history and concurrent condition. On 13-AUG-2015 the patient was vaccinated with a dose of COMVAX (strength, dose and route unknown) and PENTACEL (strength, doses and route unknown), resulting in a double dose of hepatitis b vaccine. The reporter stated that the patient was only supposed to receive an unspecified hepatitis B vaccine (manufacturer unknown) with PENTACEL. However, since the boxes for COMVAX and the unspecified hepatitis B vaccine (manufacturer unknown) had an identical color, it resulted in mixing up the two products. No adverse effects were reported. Additional information has been requested.
Pt recvd vax on 22SEP92 & 29SEP92 pt devel maculo papular rash on face & limbs; No further details were provided;
Woke up the morning of 04/22/2021 unable to control the right side of my face. Fearing it was a result of stroke I went to the emergency room at hospital. I was examined by a neurologist who determined that it was Bell?s Polsy. I was admitted overnight for observation and discharged the following day. The symptoms continue to exist today. I?m reporting it now after reading news reports that Johnson and Johnson might cause Bell?s Polsy.
Immediately after the shot had bad H/A, burning in the rib cage like a fire was burning. Lower lip became numb. Very metallic taste in mouth with burning.  The numbness continued until the next day, then went away. Then 26 hrs later, had a catch in the lower back going into the hip, very intense pain for 10 minutes. Had to sit down an rest. Then burning in the ribs cage again.  Then vomited intensely, uncontrollably it lasted about 30mins.  Then went to bed with a heating pad for about 1 hr.  Then had the projectile vomiting again. It lasted 20mins. Then took Percocet and went to bed.  Then had chills.  got up 8 time with night sweats.  This morning she feels much better, but still with a terrible H/A.  Still feels tired, fatigue.  Called MD to report.  Got a nausea medication.
2 seizures in 4 m/o at 9 pm and 12 midnight. No fever until about 24 hours after vaccination/seizures. Previously well: PMH not contributory. 1/13/09-records received for DOS 10/29-10/31/08 and 11/8-11/11/08-DC DX: Siezure. Status epilepticus. Fever.
The adverse events were injection site pain, nausea, headache. I took Ibuprofen 800 mg before bed and all symptoms have resolved besides the injection site pain.
Patient stated she felt hot at injection site. RN (self) felt site-very hot,  slight swelling. No redness No difficulty breathing. Placed ice at site, took Claritin 10mg. BP and HR taken, with in normal limits. Observed for 30min. Swelling decreased. Site cool to touch (due to ice at site). No redness, difficulty breathing, rash, increase heart rate or RR rate.  Instructed to go to ER if any swelling, redness, rash, throat swelling, increase heart rate, difficulty breathing or other concerns later. At end of time She stated in past when getting flu vaccine at day time, that  night site became hot. Instructed in future to inform provider of this reaction prior to getting future vaccines.
About 45 mins after taking the vaccine I felt as if I had a  tightening in my throat.This sensation lasted for about 8 hrs.Then it subsided.....no other adverse side effects were felt.
one had developed a fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (one had developed a fever) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (one had developed a fever). At the time of the report, PYREXIA (one had developed a fever) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information was provided.  It was  reported that one of the elderly neighbor of the reporter developed fever for 24 hours. No treatment medication information was given.
The pt experienced itching, painful rash on left shoulder. Lesion cultured for wild strain varicella versus vaccine strain. Treated with acyclovir.
Information has been received from a registered nurse concerning a 65-year-old female with hypertension (who is being treated with unspecified meds) who on 31-JAN-2008 at 12:45 pm was vaccinated subcutaneous with her first dose of ZOSTAVAX (lot # 659326/1824U).  There were no illnesses at the time of vaccination.  On 31-JAN-2008 at 12:55 pm the patient felt lightheaded and had a low blood pressure of 78/42.  It was reported that the patient's pulse was very weak.  The nurse continued to monitor the patient and treated her by lowering her head between her knees.  The patient was also given orange juice during this episode.  Symptoms passed within 25 minutes.  Blood Pressure came up to 98/50.  It was recommended the patient make an appointment to see her doctor.  Three hours later the nurse contacted the patient's husband by phone and he reported she was well.  On the 31-JAN-2008 the patient recovered.  A product quality complaint was not involved.  Additional information has been requested.
6 hours post vax, the pt developed 70 mm x 50 mm erythema and induration in left deltoid. Decreased range of motion with pain on abduction.
blood clot disorder; This is a spontaneous report received from contactable consumer, the patient via Medical Information from Pfizer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 19May2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced blood clot disorder. She was not asked about this on the 1st dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Temp of 101.6 axillary. Decreased feeding, fussy, sleeping poorly.
Chief Complaint: DIB Additional Medical History:  This 63-year-old male with a history of COPD, alpha-1 antitrypsin deficiency, schizophrenia, anxiety and depression who presents to the emergency department with complaint of cough and difficulty in breathing that has been ongoing problem for approximately 1 month.  As stated before he has a history of COPD and alpha-1 antitrypsin deficiency and continues to smoke occasionally.  He was seen in the emergency department on 12/12/2022 for similar complaint.  He describes cough wheezing and I assume the cough is productive because he says he feels that he has infection and that there is "a yucky taste" in his mouth when he coughs.  He is also complaining of some chest discomfort and says he hurts all over.  Patient specifically describes the chest pain as a diffuse allover ache in his chest like he has been working really hard, but says he has not been working.  Says its been going on for 2 days continuous nothing seems to provoke or palliate it and he currently rates it as a 5 out of 10 in severity.  He also has some back pain associated with it he does not describe any loss of sense of taste or smell.
This spontaneous report as received from a 53 year old male patient regarding himself. No concurrent conditions or medical history was reported. Patient had allergy to aspirin and ATIVAN. On 10-MAR-2016, the patient was vaccinated with ZOSTAVAX (dosing details, route, lot# and expiry date were not reported). There was no concomitant medication. On 10-MAR-2016, the patient experienced swollen gland, redness, and itching at the injection site. No treatment was given for the events. There was no lab tests done. The patient did not seek any medical attention. The outcome of the events was reported as not recovered/not resolved. The reporter did not provide the causality between the events and the suspect therapy. There were no product quality complaints (PQC) involved. Additional information is not expected as no contact details were provided.
After PROQUAD was given, became very irritable with behavioral changes that have not gone away - KINRIX was also given - also very emotional.
My daughter received a DTAP vaccination on 7/31/09.  She experienced significant swelling, redness, pain, and heat at the injection site in an area about 4" in diameter which lasted for 48 hours.  I did not inspect the site prior to putting her to bed but discovered the swollen area the next morning while we were swimming.  At 72 hours, she still had redness, heat, tenderness, and some swelling in an area approximately 4" in diameter but it was beginning to resolve.  It is now 5 days after the shot (8/5/09) and the site is still reddish in an area approximately 4" in diameter but the heat is gone and it is no longer tender to the touch.  There is quite a large lump in the center of the red area which is painful when pressed.  My dr. encouraged us to use ice packs, benadryl, arnica montana, and Motrin during the first 72 hours.  The benadryl was administered for the first time about 48 hours after the injection and seemed to have an almost immediate effect as the site was much improved the following morning.  I've got photos showing the red area and the extent of the swelling taken over several days if they would be helpful.
Joint pain on left wrist and ankle; Joint pain on left wrist and ankle; swelling; This 79- year-old female patient contactable consumer, who reported for herself, received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EN5318), via an unspecified route of administration, on 30Jan2021 at 09:15 AM as a single dose for COVID-19 immunization, in left arm, in Doctor's office/urgent care. Patient is not pregnant. She has had no other vaccines on the same day or in the past 4 weeks. The patient did not have COVID-19 prior to the vaccine. Relevant medical history included: Cancer, high blood pressure, cholesterol. Patient has a known allergies: Iodine. Patient taking unspecified concomitant medications. On 02Feb2021, the patient experienced Joint pain on left wrist and ankle, swelling. The clinical outcome of the events was not recovered. It was reported that since the vaccination, the patient had not been tested for COVID-19.
pt recvd vax & 2 wks p/vax exp elevated liver enzymes & elevated sedimentation rate;liver function tests returned to nl;
Information has been received from a published article, title as stated above, from an physician concerning a 4 year old female (case patient 2) with alveolar rhabdomyosarcoma who was vaccinated with VARIVAX (Oka/Merck).  This report was part of a post-marketing surveillance program describing the outbreak of varicella with likely breakthrough disease in a population of pediatric cancer patients receiving treatment for cancer in a healthcare setting with an affiliated group housing facility.  In October 2004, 3 days after the identification of the index subject with possible herpes zoster, the subject presented with papulovesicular lesions on her back, scalp, and trunk.  Her lesions tested negative for VZV by fluorescent antibody test and by viral culture.  She received a diagnosis of varicella on the basis of clinical characteristics and known varicella exposure from the index subject living in the same housing facility.  Subsequently, the subject was admitted to the hospital and given acyclovir therapy.  It was reported that the subject had documented VZV antibody titer prior to exposure, considering likely breakthrough disease (defined as varicella with onset at least 42 days after vaccination).  The subject did not experience any medical complications related to varicella.  At this time, relationship of breakthrough varicella to study therapy is unknown.  Results of the study revealed that in approximately 16 days, varicella had been detected in 7 children (the index case, 5 secondary cases and 1 tertiary case).  Of the 7 identified cases, 4 appeared to be cases of breakthrough disease in previously vaccinated children.  The outbreak resulted in the exposure of 82 families at a pediatric group housing facility, 28 children at the schoolroom and 77 patients, 150 family members, and 9 staff members at 3 outpatient clinics.  This study highlights the important role that breakthrough varicella can play in healthcare centers with affiliated group housing.  Formal recommendations on the management of exposed individuals who have been vaccinated should be made aware in such settings, especially if immunocompromised hosts are present.  This article also discussed the experience of a 3-year-old boy, a 7-year-old boy and a female child while on therapy with VARIVAX (Oka/Merck) (WAES # 0812USA01703, 0812USA01704 and 0812USA01705).  This is one of several reports from the same source.  Additional information has been requested.  A copy of the published article is attached as further documentation of the patient's experience.
102-104 fever since 5/10, must have tylenol/motrin every 4 hrs. severe rash in pubic/daiper area. Loss of appetite, as well as no interest in fluids. Constant crying, not consolable, irritable and fussy and extra tired. SHe wakes up from a 1.5-2hr nap and is tired again within an hour. SHE IS MISERABLE
Came to hospital d/t unresponsiveness and found to have COVID, UTI, and encephalopathy. Treatment includes Remdesivir, IV fluids, hypoxia observations.
STINGING SENSATION; SWELLING; RASH ON OPPOSITE FOREARM FROM INJECTION SITE; HEADACHE; TIRED; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included hypothyroidism, and high cholesterol, and concurrent conditions included diabetes insipidus, non smoker, and non alcohol user, and other pre-existing medical conditions included no drug abuse or illicit drug usage and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020,  expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced tired. On 07-APR-2021, the subject experienced stinging sensation. On 07-APR-2021, the subject experienced swelling. On 07-APR-2021, the subject experienced rash on opposite forearm from injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, rash on opposite forearm from injection site, swelling, and stinging sensation, and the outcome of tired was not reported. This report was non-serious.
Allergic reaction with respiratory distress, difficulty swallowing. Treated with steroids and Benadryl. RX for Prednisone 20mg BID for 5 days.