chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a pharmacist on 14 October 2015. This case involves a 72-years-old female patient who was vaccinated with a dose of FLUZONE HD (batch number: UI459AB, expiry date: 30 April 2016, dose, dose in series, were not reported) intramuscularly in left deltoid on 11 September 2015. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as allergic to milk, cheese, slight sensitivity to eggs. The patient had previously received flu vaccines with no previous reactions. Concomitant medications were not reported. On 12 September 2015, one day following the vaccination, the patient had experienced pain in shoulder area of left arm which continued till today (14 October 2015). It was reported that the pain is a sharp pain and keeps her awake at night. Relevant diagnostic tests/laboratory data and corrective treatment was not reported. The patient was not recovered from the events. List of documents held by sender: none.
urinating more than usual; Chills; Fever; nausea for more than one week; 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 POLLAKIURIA (urinating more than usual), CHILLS (Chills), PYREXIA (Fever) and NAUSEA (nausea for more than one week) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 POLLAKIURIA (urinating more than usual), CHILLS (Chills), PYREXIA (Fever) and NAUSEA (nausea for more than one week). At the time of the report, POLLAKIURIA (urinating more than usual), CHILLS (Chills), PYREXIA (Fever) and NAUSEA (nausea for more than one week) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.   No relevant concomitant medications reported.  No treatment information was provided.   Reporter did not allow further contact
Moderna Covid Vaccine -on 2-17-2021 my left arm started hurting like it did right after my initial vaccination on 2-10-2021 around 1:30am and it hurt all day along with fatigue and body aches.  The injection site was red and the surrounding area was slightly swollen.  I took Motrin with seem to help with the pain. -2/18/2021 the injection site is still red but not a deep pain like yesterday however it is red and i have a 3 inch by 3 inch rash directly underneath the injection site.  I have taken a dose of benedryl to help with the extreme itching.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 18-year-old female patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, 1 day after receiving BEXSERO, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were unknown. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to BEXSERO. Additional details were provided as follows: The reporter stated that, 24 hours after administration of BEXSERO, the patient experienced severe pain at the injection site and the patient had trouble in lifting her arm where she got the injection. The reporter did not have any further information. This case has been linked with US2016067076 reported by same reporter.
Info has been received from a LVN concerning a 12 month old white male who on 12/29/04, was vaccinated, IM in the left arm with a 1st dose of varicella virus vaccine live (lot 648546/0272P). The LVN reported that on 9/28/05, the pt presented to the physician's office with breakthrough varicella characterized by chickenpox on his legs and back which was treated with Zyrtec. On 10/18/05, the pt returned to the physician's office with an itchy rash and was subsequently referred to a dermatologist. On 10/19/05, the pt was seen by a dermatologist who prescribed topical and oral antibiotics for folliculitis pending a nasal culture which subsequently revealed streptococcus pneumonia. In 2005, the pt recovered from the breakthrough varicella, folliculitis and streptococcus pneumonia. Additional info is not expected.
Half an hour after vaccine administered, while in waiting room with mother, patient became pale and limp with change in LOC. Patient found limp and pale with slight cyanosis of lips O2 sat. in high 80's and Heart rate 60s, attempted to give glucose and administered oxygen via nasal cannula with improved O2 sat to 100% - 911 called and pt. transferred to local hospital still weak but responsive.
1 week after vaccination, developed 2 lumps under arm in lymph nodes in arm pit the same arm as vaccine.  Was seen by doctor and having follow up visit
My mother collapsed the morning after her second shot.; She was non responsive; blood pressure was very high; limp, could not walk; squeezing sensation around head; Fatigue; This is a spontaneous report received from a contactable consumer (Patient). A 96-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EWo191) via an unspecified route of administration, administered in Arm Left on 09Jun2021 at 01:00 PM as single dose for covid-19 immunisation at Pharmacy/drug store. Medical history included renal insufficiency and Grave's Disease. Patient had no known allergies. The patient's concomitant medications were not reported but she received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19, since the vaccination. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot number: ewo176) via an unspecified route of administration, administered in Left arm on an unspecified date in May2021 at 01:00 PM covid-19 immunisation. On 10Jun2021 at 09:00, the patient collapsed the morning after her second shot, she was nonresponsive, limp, could not walk, blood pressure was very high, squeezing sensation around head (stated did not know what year it was). Ambulance was called and she was hospitalized for two days. CT scans and blood work were normal. ER (emergency room) Doctor and floor Doctor both said it was an extreme reaction to the second dose of the vaccine. Fatigue, unresponsive episodes continued for two days after she was released to home. The patient underwent lab tests and procedures which included blood pressure measurement: high, blood test: normal, computerised tomogram: normal, echocardiogram: unknown, urine analysis: unknown. Therapeutic measures were taken as a result adverse event. The outcome of events was recovering.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on close temporal relationship the causal role of the vaccine cannot be excluded for the reported events. Renal insufficiency and graves disease can be contributory to event
12:30 pm received injection. 7pm muscles in arm very sore applied cold pak. 9:15pm took two Alleve. 10:15 pm much better but still pronounced stiffness in neck and left arm and site tenderness.  Sept. 28, 2021, 4:15 am temperature 98.6. 6:23 am temperature 101.3. Took two Tylenol. 7am temperature 97.7, runny nose, slight headache. 7:50am temperature 98.4. 11:45 am temperature 98.9. 12:26pm temperature 100.1. Took two Tylenol. 3:56 pm temperature 98.4. 7pm temperature 99.1. Took two Tylenol. 8:01 pm temperature 99.5. 11:47 pm temperature 97.3. Sept. 29, 2021 temperature within normal range but very and very tired. 1:52 pm took two Alleve and felt nearly normal about an hour later.
ill the next day; was in bed; had flu like symptoms 12-36 hours after booster shot; I started feeling very tired; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Dec2021 (Lot number: FF8841) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOXYL; VITAMIN D [COLECALCIFEROL]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 23Mar2021, when the patient was 43 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 03Mar2021, when the patient was 43 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021, outcome "unknown", described as "booster"; INFLUENZA LIKE ILLNESS (non-serious) with onset 08Dec2021 21:00, outcome "recovered" (2021), described as "had flu like symptoms 12-36 hours after booster shot"; FATIGUE (non-serious) with onset 08Dec2021, outcome "unknown", described as "I started feeling very tired"; ILLNESS (non-serious) with onset 09Dec2021, outcome "unknown", described as "ill the next day"; BED REST (non-serious) with onset 09Dec2021, outcome "unknown", described as "was in bed". Therapeutic measures were taken as a result of influenza like illness.  Additional information: The patient was not pregnant at the time of vaccination. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. It was reported that, the patient got the booster (which was on 08Dec2021). Stated that, she started feeling very tired with flu-like symptoms that evening and was in bed/ill the next day. Stated that, the following day, she reported it. Stated that, this is why there was a delay. Stated that, she wasn't in a position to report her symptoms as she was having them. Stated that, the patient was having flu-like symptoms and was in a haze and did not report until after the symptoms had passed. The reporter seriousness for the events was reported as non-serious. Treatment medication included Advil taken for the event influenza like illness.  Follow-up attempts are completed. No further information is expected.
17 days post vax the pt developed skin lesion that consisted of 10-15 insect bites on her arms and legs. The areas resolved themselves without scabbing.
PATIENT WAS INADVERTENTLY GIVEN HIB AND VAXELIS VACCINE ON THE SAME APPT DATE/TIME
Vasovagal response, short myoclonic seizure lasting 2 seconds, post ictal for roughly 2 minutes.
Patient was given Benadryl (25mg) for wheezing after vaccine administration. Symptoms of wheezing and shortness of breath resolved with administration of home med of albuterol. Oxygenation was 100% and resolution of symptoms at 0940.
Information has been received from a physician concerning a 4 year old male with mild asthma and no allergies who on an unspecified date in February 2006, was vaccinated with a 0.5 mL second dose of MMR II. Concomitant therapy included montelukast sodium (MSD) and cetirizine hydrochloride (ZYRTEC). It was noted that the patient received the first dose of MMR II "a few years ago" with no adverse reaction noted. Within a few minutes of receiving the vaccine, the patient had an anaphylactic reaction with hives and wheezing. He was treated with an injection of epinephrine (ADRENALINE) and with steroids. His condition resolved and no additional treatment was required. The patient was recently seen by the physician and tested negative was egg, chicken, and gelatin allergies. He was also negative for dust, pollen, and mold. A spirometry the week of 13-NOV-2006 was negative. A product quality complaint was not involved. Follow-up information was received from the physician who reported that he no longer had access to the patient's chart. He noted that the patient did have an immediate reaction to MMR II. The patient's experience was considered to be immediately life-threatening and an other important medical event by the physician. No further information is expected.
7X4.5 cm lump left deltoid. C/O diarrhea and nausea x 36 hours.
Got the first shingrix shot in january. 2 days later got shingles; Still have major post herpetic pain / major aching in that spot; Major aching in that spot; not helped me; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included valaciclovir hydrochloride (Valtrex) unknown for herpes zoster.   In January 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Valtrex at an unknown dose once daily. On an unknown date, 2 days after receiving Shingrix and not applicable after starting Valtrex, the patient experienced shingles, post herpetic neuralgia, pain and drug ineffective. The action taken with Valtrex was unknown. On an unknown date, the outcome of the shingles and drug ineffective were unknown and the outcome of the post herpetic neuralgia and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, post herpetic neuralgia and pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by pharmacist for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received 1st dose of Shingrix and 2 days after the vaccination the patient experience shingles on right back. The patient stated that he/she still had major post herpetic pain, no blisters but major aching in that spot. The patient had been taking Valtrex once daily which did not help the patient and patient asked should he/she stopped it before the 2nd dose of Shingrix. The patient asked if he/she could get 2nd dose of Shingrix.
Within 24 hours post vax, pt developed an injection site reaction characterized by swelling and warmth.  The reporter stated that the vaccine may have been injected subcutaneously.  The pt recovered.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 at 10:30 as dose number unknown, single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing); "Known allergies: asparagus" (unspecified if ongoing); "Known allergies: spinach" (unspecified if ongoing); "Known allergies: strawberries (mild)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received regarding a case in litigation from a physician concerning a 30-year-old patient who was vaccinated with a second dose of RECOMBIVAX HB.  On an unspecified date, following the second dose of RECOMBIVAX HB, the patient developed a rash and pain.  A third dose of RECOMBIVAX HB was not given.  The patient sought unspecified medical attention.  At the time of the report the patient's status was unknown.  A product quality complaint was not involved.  Additional information has been requested.
7:00 am - Onset of event was bleeding while urinating.  Following this, extreme pain while urinating.  Within a few hours, bleeding vaginally.  Later that day, a huge hemmorhoid appeared with bleeding from anus and  Bleeding from nose. Extreme pain trying to urinate, but minimal amount would pass.    5:00 a.m. following day - Went to hospital, was admitted through Emergency.  Transferred to larger hospital.   Was put on IVIG, and  admitted to hospital, High Acute Unit.  Was in hospital 6 days.
Patient complained of dry cough, swelling of hands, lips, some chest tightness. Pt. given O2 at 2 L /min. VSS.
Sore arm for 1/2 day after shot was expected. However, one week after injection (3/39/21), I became dizzy. The next morning (3/30/21), I was extremely dizzy, very nauseous, and had a severe headache. I was hardly able to get out of bed,  and unable to work that day. Symptoms lasted until the morning of 3/31/21.
Information has been received on 05-FEB-2019 from a lawyer and a female patient regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) on or about 05-JUN-2013 at a medical clinic, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. The patient was treated by a nurse practitioner for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the vaccine ZOSTAVAX 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.
Information has been received from a physician concerning a 15 year old male patient who on an unspecified date was vaccinated with MMR II. On 08-NOV-2009, the patient developed mumps. The patient was afebrile. On 12-NOV-2009, the patient was diagnosed with right parotitis. It was unknown if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from the physician concerning the patient who on 20-DEC-2009 had an onset of mumps.  The patient had a fever of 100F. The patient was diagnosed with left parotitis on 20-DEC-2010. He refused to perform the blood work. It was unknown if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
PATIENT FELT LIGHT HEADED IMMEDIATELY AFTER SHINGRIX SHOT WHICH WAS ADMINISTERED SECOND AFTER THE FLU VACCINE. PATIENT PUT HEAD DOWN AND PASSED OUT FOR A FEW SECONDS. LAID DOWN ON THE FLOOR FOR A FEW MINUTES THEN VOMITED. PATIENT FELT BETTER RIGHT AFTER VOMITING AND WAS ABLE TO SIT UP AND DRINK WATER.
I developed a severe cough I was given a covid test still waiting for results. I was given an inhaler and cough medicine.
After 2nd dose of Pfizer covid injection, felt tired the next day Felt tired and had chills. Monday chills and headache.  This week has had "out of control" anxiety, through the roof.  This week has been sleeping 9-10 hours a night Headache: on top of her head, all around head, and right temple.  +Nausea: with driving. Noticed eyes diverting.  No vomiting.  +weakness - generalized +right arm tingly Feels a lot better now.
Amennorhea - missed two menstrual periods following first Gardasil injection.  Patient was taking hormonal contraceptives at the time and never missed a menstrual period before.  Patient was not pregnant.  Menstrual periods resumed after two missed months.
HIVES; SWELLING; HOT TO TOUCH; PAIN FROM NECK TO HAND; ITCHING  TREATMENT: ANTIHISTAMINES
had the Pfizer vaccine LOT WE0169  clinic  she had in less 48 h generalized hives + swollen joints and fingers as well SOB + chest tightness    she was prescribed Benadryl but still after 10 days she is still w same symptoms and hives getting more uncontrolled
Pain throughout her arm. She is having a soreness, tightness, and hard to lift her arm. Muscle spasms throughout her arm and back. All on the left arm. Went to the ER and was told to take Motrin.
11x12 cm area w/swelling, induration, tenderness lt deltoid; no fever; noted 24hrs p/vax;
After administering vaccinations patient stated that she felt faint. RN and mother laid patient on the ground and elevated knees. RN gave patient a juice box. Patient was coherent and did not lose consciousness. After 10 minutes of laying on ground and drinking juice box patient sat in chair for several minutes and drank another juice box. Patient stated she felt well after 10 more minutes of observation. Mother and patient ambulated out of clinic without difficulty.
This spontaneous report was received from a registered nurse and a pharmacist and refers to a 4-year-old male patient. The patient had no pre-existing physician-diagnosed allergies, birth defects or medical conditions. There was no event following a prior vaccination. He had no illness at the time of vaccine administration. On 16-OCT-2017, the patient was vaccinated with the second dose of properly stored PROQUAD (rHA) lot # M018638, intramuscularly (dose was not provided), which expired on 11-OCT-2017. Sterile diluent (STERILE DILUENT) used for reconstitution of vaccine was properly stored. Concomitant vaccine, given on the same date, included KINRIX. It was also reported, that there was unspecified error in preparation for administration. No adverse events were reported (also reported that it was prescription drug treatment required for the experience). The reporter would wait 2 months and then reimburse the cost of vaccine.
pt recv vax;mom gave apap,elixir;later mom saw pt shaking all over & blue around lips;called paramedics;to hosp;en route pt had petite sz w/ staring for 1.25 mins; T105.5R by paramedics;adm to er;electrolytes & CBC nl;BUN=18;gave Ibuprofen