chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 25-SEP-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 14-MAY-2015, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
apparent apneic episode w/cyanosis seen in ER, dx w/GER 7 sent home on reflux precautions;
Patient was given the pediatric dose of Hepatitis A vaccine, she had no serious reaction or any medical issues following injection.
Nausea, fever , body aches  , chills loss of appetite fever from 99 to 100 degrees F for over one week
Left thigh patient developed 10 x 11 cm erythematous swelling to left thigh, mildly tender,noted 15 minutes after injection. pt monitored for another 20 minutes and released home. no sob or cough noted. family advised Benadryl at home
Enlarged lymph node (size of a plum) under left arm. The site of the vaccination was on the left arm.
bilateral hearing loss; postherpetic neuralgia; intrinsic eczema; herpes zoster; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or around 18-OCT-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown, date shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered shingles rashes on his lower back and mid left back, muscular lower back pain and loss of hearing. He was diagnosed with herpes zoster, postherpetic neuralgia, intrinsic eczema and bilateral hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to using the vaccine. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment, and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   The events were determined to be disabling.  Upon internal review, the event of bilateral hearing loss was considered to be medically significant.
red hot; hard; itchy; red; Sore arm; Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (red hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (itchy) and FATIGUE (Tired) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032120A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hiatal hernia (Started years ago), GERD, High cholesterol and Hay fever. Concurrent medical conditions included Penicillin allergy (Hives Started years ago), Drug allergy (Hives Started years ago) and Hypersensitivity NOS. Concomitant products included SIMVASTATIN for Cholesterol, OMEPRAZOLE for Hiatal hernia, store brand SPECTRAVITE PERFORMANCE, ASPIRIN [ACETYLSALICYLIC ACID], CALCIUM, VITAMIN D [VITAMIN D NOS], VITAMIN C [ASCORBIC ACID] and FISH OIL for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired). In February 2021, the patient experienced VACCINATION SITE WARMTH (red hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red). In February 2021, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (red hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (itchy), FATIGUE (Tired) and VACCINATION SITE ERYTHEMA (red) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information is provided.  Patient does not have history of Anaphylaxis, Hives/ Urticaria, or Asthma.  Doctor has done many blood tests mainly for autoimmune diseases all came back negative on an unspecified date.   This case was linked to MOD-2021-133344 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow-up doc received on 27-Apr-2021in which Conmeds, Medical History and Information pertaining to dose 1 events updated On 01-Jun-2021: follow-up doc received on 01-jun-2021
Baby woke up screaming uncontrollably with a fever of 104 F parents gave her Ibuprofen but she threw it up. Instructed them to take her to ER for evaluation and to call back to let our agency know what findings were. 06/19 no tc received on 06/18. RN contacted them, father stated that the fever broke, they didn't take her to MD and is fine today.
bilateral periorbital swelling; Myalgia; Fever; This is a spontaneous report from a contactable physician.  A 49-year-old male patient received BNT162B2, via an unspecified route of administration on an unspecified date  as single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced bilateral periorbital swelling, myalgia and fever on an unspecified date, which were medically significant. Description was as followed:  patient went to the emergency department. The vaccines was given on a Wednesday afternoon, and patient presented with bilateral periorbital swelling this morning, myalgias, and fever.  Therapeutic measures were taken as a result of swelling, myalgia and fever; the only treatment given was diphenhydramine (BENADRYL) orally.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, periorbital swelling, myalgia and fever, there is a reasonable possibility that the events are related to BNT162 vaccine. 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.
She developed Nausea,Chills,Fever lasting for about 7 days.Her Appetite had gotten worst.Body aches increased,Constipation got bad,increased severity of Head aches.
This is a prospective pregnancy case. This 19-year-old female subject was enrolled in an open label study, a prospective, exploratory study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with BOOSTRIX during pregnancy or within 28 days preceding conception. The subject received BOOSTRIX .5 ml on an unknown date. The subject's estimated date of delivery was 1st OCTOBER 2015. On 9th SEPTEMBER 2015, an unknown time after receiving BOOSTRIX, the subject developed injection site warmth (non-serious). Additional event(s) included injection site tenderness on 9th SEPTEMBER 2015, injection site swelling on 9th SEPTEMBER 2015 and vaccine exposure during pregnancy. The outcome of injection site warmth was recovering/resolving. The outcome(s) of the additional event(s) included injection site tenderness (unknown), injection site swelling (recovering/resolving) and vaccine exposure during pregnancy(unknown). The pregnancy is ongoing. It was unknown if the investigatory considered the injection site warmth, injection site tenderness and injection site swelling to be related to BOOSTRIX. Additional details provided were as follows: On unknown date, the patient received a dose of BOOSTRIX vaccine (batch number: NL7K3, expiry date: 15th SEPTEMBER 2017) and was exposed to the vaccine at an unknown trimester. The last menstrual date of the patient was not provided. On 9th SEPTEMBER 2015, an unknown time after receiving the BOOSTRIX,, the patient experienced warm to touch, tenderness, and swollen at injection site. The patient reported to healthcare professional that the events were subsiding, but still irritated.
Information has been received regarding a case in litigation concerning a 32 month old male who on 07/25/01 was vaccinated with MMRII (Lot # not provided).  It was reported that the child was born on 01/04/00 and has been in the care and custody of his parents from birth to present.  He was born a perfectly normal, healthy baby boy.  Developmentally, neurologically and socially, he achieved every developmental milestone anticipated of all normally developing children.  On 03/17/00, at approximately two months of age, he received four vaccine injections, including: an inactivated poliovirus (IPV) vaccine; a haemophilus influenza type b (HIB) vaccine; a Hep B vaccine (manufacturer unknown); and acellular DTP shot (DTAP).  On 05/19/00, at approximately four months of age, he received four vaccine injections, including: an inactivated poliovirus (IPV) vaccine; a haemophilus influenza type b (HIB) vaccine; a Hep B vaccine (manufacturer unknown); and acellular DTP shot (DTAP).  On 07/25/01, at approximately 18 months of age, the child received three more vaccine injections, including an inactivated poliovirus (IPV) vaccine; acellular DTP shot (DTAP); and MMRII.  On 10/02/02 the pt was diagnosed with severe autism.  It was reported that, "Thimerosal used in vaccines and the MMR (measles, mumps, rubella) vaccine, individually and/or jointly combined caused (the child's) autism spectrum disorder.  Upon internal review, autism was considered to be an other important medical event (OMIC).  Additional information is expected.
Starting 06/14/2022, I woke up with a sore throat and fatigue. Over the next few days, I developed more symptoms: cough, chest and nasal congestion, body aches, more fatigue, headache, and at some point I had a brief case of diarrhea and a moment of dizziness. On 06/17/2022, I tested positive for COVID-19 via an at home test. I quarantined, rested and felt lousy. Around 06/20/2022, I called my doctor's office to see about isolation recommendations and other COVID recommendations. I did not go anywhere until I tested negative which was on 06/26/2022 which is about how long my symptoms lasted. This is also when I got my energy back. At no point during this event did I lose my sense of taste and smell or have trouble breathing other than the cough.
4-5 droplets came out from syringe; Vaccine maybe touched patient´s arm; Vaccine maybe touched patient´s arm; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number P39N2, expiry date 25th September 2023) for prophylaxis.   On 4th November 2022, the patient received the 2nd dose of Shingrix. On 4th November 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered, exposure via skin contact and accidental exposure while administering drug. On an unknown date, the outcome of the incomplete dose administered, exposure via skin contact and accidental exposure while administering drug were unknown.     Additional Information: GSK Receipt Date: 04-NOV-2022 Reporter's comment: Pharmacist reported that while she was administering a Shingrix vaccine in the right arm to a patient, 4-5 droplets of the vaccine came out around the base of the needle where it attached to the syringe while the syringe with the reconstituted vaccine was in the patient's arm. The pharmacist said 4-5 droplets of the reconstituted Shingrix vaccine when it came out of the syringe on the patient's pant and maybe the patient's arms.  The reporter did not consent to follow-up. Additional Supportive Information: The 4-5 droplets of the reconstituted Shingrix vaccine when it came out of the syringe on the patient's pant and maybe the patient's arms, which led incomplete dose administered, exposure via skin contact and accidental exposure while administering drug. The case US2022161294 was identified as duplicate of this case. The case US2022161294 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient. The case is linked to the case US2022AMR162313, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR162313:Same reporter
arm rash that got larger then eventually subsided; right arm was red; "apricot" like lump at the injection site "like a bolus in the muscle"; "injection site reaction"; right arm was itchy; right arm was hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION, PRURITUS, FEELING HOT, RASH, and ERYTHEMA in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Nov-2021, the patient experienced VACCINATION SITE REACTION, PRURITUS, FEELING HOT, ERYTHEMA, and VACCINATION SITE MASS. On 28-Nov-2021, the patient experienced RASH. On 30-Nov-2021, PRURITUS outcome was unknown, FEELING HOT, ERYTHEMA, and VACCINATION SITE MASS had resolved. At the time of the report, VACCINATION SITE REACTION outcome was unknown and RASH had resolved.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-403231, MOD-2021-402915 (Patient Link).
This case was reported by a healthcare professional and described the occurrence of injection arm pain in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL (unknown, unknown arm). Less than one month after vaccination with FLULAVAL, the subject experienced injection arm pain. The healthcare professional reported that the subject received FLULAVAL "a couple of weeks ago" and experienced persistent pain in the arm of injection since then. At the time of reporting the outcome of the event was unspecified.
Day following vaccine administration, red, warm rash on (R) forearm and at (R) thumb only on arm where HPV 9 administered.
Fever of 101 for three days. Around 8 pm on January 1st sever vertigo anytime changing position. Went to open MD who recommended epley maneuver . Was told to do this for "several days" and then come back if it did not go away. Maneuver was done for three days before vertigo went away, but constant dizziness for another three days, and then intermittent dizziness still ongoing. Called into work.
Had a 20cm area of redness and induration surrounding shot site on anterior thigh, mildly warm and tender to touch. Pt afebrile and walking well. Both shots given 3cm apart. Previously, no reaction to DTAP. No rash elsewhere.
Pt arrived on 11/27 post MVC with altered mental status, acute alcohol intoxication, and an open right ankle fracture-dislocation. She was tested for COVID on 11/30 due to needing inpatient rehab placement and was found to be positive, but asymptomatic.
Walking out of pediatrician and He started looking white, I grabbed his hand and he started walking like a drunk man... he collapsed and was incoherent for maybe two minutes or so and he was convulsing, heavy deep breathing, and when he woke up was very confused and didn't talk for a good 20 mins. Weird thing is the pediatrician didn't send him to hospital or anything..: they requested an EKG and just evaluated him for a few minutes after the seizure episode which is what the doctor in the ER confirmed had happened.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 08-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time of the first time was 64 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the highest recorded temperature of 49 Fahrenheit degree. The total cumulative excursion time of the third time was 16 hours with the lowest recorded temperature of 29 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 21-JUN-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter.; Sender's Comments:  US-009507513-2106USA007355:
I had numbness in my  hands and legs, starting 2 days after the injection.  The numbness comes and goes and is mostly in my right hand and foot, though at times the left side is still affected.  I also have occasional mild pain in my arms and legs.
Received Hep A and Flumist, left room and pt. became diaphoretic, fell at hit front of head, seized and was transported to ER.
Patient was listed on clinical service appointment for a Pfizer vaccine at 9:40 am . In the computer the prescription was listed on prescription  7003537 as a Pfizer vaccine. After I administered the vaccine to the patient she showed me a plastic card that she had bought to put the vaccine in - i explained to her that she could also retrieve another online - that is when she informed me that her first vaccine was Moderna . I called patient later that day to see how she was feeling  but she had gone out . I talked to her at 6:30 pm that day and she stated that she was  fine except had a headache and some pain at the injection site . I told her that those  symptoms can occur and  to put ice on site.
Within minutes my right index finger began feeling tingly. I also smelled things that were not present. It smelled like sweaty putrid gym clothing? It?s hard to narrow that down but it is a scent that lingers incessantly. The next morning my neck was heavily stiff. Today, I began to feel just under my sternum, a bloated, inflammed sensation. It?s not painful to the touch but it?s very apparent that something is occurring in that location. This is day two. This is chronologically how it has occurred. With this only being the second day, after the first dose, after contracting COVID Twice, it?s alarming that this is occurring.
A bowel movement that it was red; This spontaneous case was reported by a consumer and describes the occurrence of FAECES DISCOLOURED (A bowel movement that it was red) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced FAECES DISCOLOURED (A bowel movement that it was red). At the time of the report, FAECES DISCOLOURED (A bowel movement that it was red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Developed fever to 103.7 F + faint macular rash 6 days after receiving MMR and Varivax.