chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a health professional regarding a 26 month old male pt who experienced wrong route of vaccination, injection site reaction, injection site warmth, injection site redness and injection site inflammation.  At 26 months of age, the pt received a dose on 09/18/03.  Relevant medical history was not provided.  Indication for Prevnar was immunization.  Product was administered on 09/18/03.  Dose regimen was 0.5mL (SC).  Pt was not taking concomitant therapy.  The pt was inadvertently administered a SC injection (medication error) and experienced injection site reaction (injection site reaction NOS), injection site warmth (injection site warmth), injection site redness (injection site erythema) and injection site inflammation (injection site inflammation) on 09/18/03.  No treatment was prescribed.  No additional information was available at the time of this report.
Joint pain all over body; Weakness  in arms and legs; Trouble rising from chair, getting out of bed; Trouble walking; Soreness in muscles; This is a spontaneous report from a contactable consumer (patient).   A 79-year-old male patient reported for himself who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6203), via an unspecified route of administration in right arm on 25Feb2021 at 08:15 (at the age of 79-year-old) as dose 2, single for covid-19 immunization at other facility. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL9264), via an unspecified route of administration in left arm on 02Feb2021 at 13:15 (at the age of 79-year-old) as dose 1, single for covid-19 immunization at other facility. Medical history included anemia, kidney stones, aoric valve stenosis, stage 3 kidney disease and cardic pacemaker. Patient known allergies included niacin, cephalexin and cephalosporins. Concomitant medications included atrovastatin, buspirone, Eliquis (apixaban), sertraline and Toprol (metoprolol succinate). Prior to the 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 four weeks prior to the vaccination. Patient received some other medications like atrovastatin, buspirone, Eliquis, sertraline and Toprol in two weeks. On 28Feb2021, patient experienced joint pain all over body, weakness in arms and legs, trouble rising from chair, getting out of bed, walking and soreness in muscles resulted in visiting doctor or other healthcare professional office/clinic visit. Therapeutic measures were reported as no. The outcome of the events was reported as not recovered.   No follow-up attempts are possible. No further information is expected.
Patient reported after receiving booster dose and sitting in observation that they were immunocompromised and needed the full dose. Per CDC guidelines, a second half dose was administered on same clinic day.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 03-JUN-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 "10 PK 0.5 ml SD-PFS LLok wTip" lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration and anatomical location were not provided), which was stored at -1.11 Celsius Degrees for 80 hours, 8.33 Celsius Degrees for 416 hours, 9.44 Celsius Degrees for 168 hours, 8.88 Celsius Degrees for 24 hours, -3.0 Celsius Degrees for 1172 hours and 15 Celsius Degrees for 56 hours. The type of excursion was refrigerator. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, since 05-AUG-2015, the patients were vaccinated with unspecified number of improperly stored doses of GARDASIL (lot # K007264; expiration date 02-MAR-2017) (dose, strength and route of administration were not reported). It was reported that the doses were exposed to temperatures outside of the recommended range. There was no concomitant medication reported and no adverse effects were reported. Additional information has been requested. This is one of four reports received from the same reporter.
Pt's arm swelled quickly after receiving the vaccination. Swelling slowed after a minute or so. Pt was feeling fine.
Having balance issues walking and standing. Bright white lights flashing.  Woke up  one morning prior to this booster and could not walk. Ten weeks ago I had spine surgery for degenerative stenosis and lumbar decompression and disectomy (sp).
Patient reports within a couple of hours of the administration of the vaccine when she was at home she started to have pain in area of administration of the vaccine, body pain and headache. Reports area of vaccination inflamed and looked red. She reports that the pain radiated to the breast area, and the pacemaker area. Reports lasting 2 days of symptoms and warm feeling in the arm. Patient reports having administered the influenza vaccine in the same arm 13 days ago and having similar symptoms.
Narrative: 100 yo male with PMH COPD, BPH, Afib, OA, and GERD under hospice care (unsure of location) died on 4/12/2021, 4 days after his second Moderna vaccine dose on 4/8/2021. Pt received first dose on 3/12/2021. Both doses were administered without complications. This death is being reported since pt died within 42 days of the last covid-19 vaccine. No other information found in records regarding this death. Records only show that a family member called to notify the agency of patient's death.
afib; My heart has not been beating right since vaccinated/ showed heart not pumping only at 35 %; heart rate was high; leakage of two valves; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 18:45 (Lot number: 30130BA) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart disease", start date: 1980 (unspecified if ongoing), notes: Heart disease back in 1980 and valve, replacement with mechanical 2002; "valve replacement", start date: 2002 (unspecified if ongoing). Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not received other vaccine in four weeks. Covid tested post vaccination. No known allergies. Concomitant medication(s) included: ALPRAZOLAM; DILTIAZEM; ZETIA; WARFARIN. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 12Oct2021, outcome "not recovered", described as "afib"; CARDIAC DISORDER (non-serious) with onset 12Oct2021, outcome "not recovered", described as "My heart has not been beating right since vaccinated/ showed heart not pumping only at 35 %"; HEART RATE INCREASED (non-serious) with onset 12Oct2021, outcome "not recovered", described as "heart rate was high"; CARDIAC VALVE DISEASE (non-serious) with onset 12Oct2021, outcome "not recovered", described as "leakage of two valves". The events "afib", "my heart has not been beating right since vaccinated/ showed heart not pumping only at 35 %", "heart rate was high" and "leakage of two valves" were evaluated at the physician office visit and emergency room visit. Patient's heart had not been beating right since vaccinated. Went to walk-in as primary would no see me. They did an ekg as patient's heart rate was high. Ekg per walk-in Detected an issue. Sent to Er. They said she was fine except heart rate was high. Hospital was full and sent her home. Followed up with cardiologist with stress test, halter monitor and last test of Echo showed heart not pumping only at 35%, leakage of two valves, afib. The patient underwent the following laboratory tests and procedures: cardiac stress test: (12Oct2021) unknown result; echocardiogram: (12Oct2021) heart not pumping only at 35%,leakage of two valve; electrocardiogram: (12Oct2021) per walk-in detected an issue; heart rate: (12Oct2021) high; sars-cov-2 test: (21Oct2021) negative. It was unknown if therapeutic measures were taken as a result of atrial fibrillation, cardiac disorder, heart rate increased, cardiac valve disease.  No follow-up attempts are needed. No further information is expected
A sudden loss of taste; A sudden loss of smell; I smelled oil/gas; This is a spontaneous report from a contactable other hcp (patient).   A 24-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3302) via an unspecified route of administration in Arm Right on 28Jan2021 at 08:00 (at the age of 24-years-old) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received first bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL1283) via an unspecified route of administration in Arm Right on 09JAN2021 at 08:00 (at the age of 24-years-old) as SINGLE DOSE for covid-19 immunisation. There were no allergies to medications, food, or other products. The patient didn't received 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, the patient has not been tested for COVID-19. On 28Jan2021 at 21:00, the patient experienced a sudden loss of taste, a sudden loss of smell and change in smelled oil/gas. Treatment was not received for the adverse events. At the time of this report event outcome was not recovered.   Follow-up attempts are completed. No further information is expected.
Presents for R Arm pain after covid vaccine, appointment was made after covid vaccine - arm is better now Right after had vaccine, pain straight down arm and lasted for few days Also after vaccine felt like legs were heavy, difficulty walking, resolved after few days
This is a spontaneous report from a contactable nurse (patient's mother). A 17-year-old female patient received the first dose of TRUMENBA, lot number: S85201, expiration date: 30Dec2019), via an unspecified route of administration on 19Jul2018 at a single dose for immunization, reported as for Meningitis B. Medical history included low blood pressure (low blood pressure kind of thing going on at one point about a year ago). The patient's concomitant medications were not reported. The mother reported that she had identical twins 17 year old daughters and were pretty small for their age only like a 100 pounds. It was reported that the mother and her daughters went to their pediatrician on 19Jul2018 (Thursday) and had the meningococcal group b rlp2086 first shot given to them of the vaccines for the meningitis B. On an unspecified date, the patient experienced chills, dizziness, nausea, she was a little hyper sensitive, she started feeling weird symptoms through her body, just not feeling right and had like low grade fevers again and it was a 100 only like low grade. The mother further reported that the other daughter had chills and nausea and that the patient had chills and nausea and hours later had dizziness. The mother also reported that the patient said maybe in her body it just kind of like one of these things where she was a little hyper sensitive because they are twin sisters and she started her period which was like that night. It was reported that the patient had a delayed reaction like hours later but before bed she started feeling weird symptoms through her body. The mother reported that the patient was feeling same like the other daughter like hours later so the feeling through the body, dizziness, just not feeling right and they had like low grade fevers again and it was a 100 only like low grade. Outcome of all the events was unknown.
Pt called 10/29/99, complaining of severe headaches a few hours after receiving immunization.  Tylenol didn't east the pain.  Has history of Migraines.  Headache went away 10/31/99.
Infant ran a slight temp. 2 days after vaccine and was sleeping hours longer during his naps then usual.  4 days after vaccine the infant had a small pimply rash and a spot of eczema on his right thigh where he received the vaccine.  5 days after the vaccine he had a rectal temp. of 101.7.  Infant was not sleeping well and was waking frequently at night when he had previously slept 11 hours straight through. The pimply rash continued to spread across his entire thigh and a little onto the lower part of his leg.   The fever ended the next day. 1 month after the vaccine, the infant's pimply rash was gone and was now only dry crusty eczema spots where the pimply bumps had been.  Aquaphor was then applied onto the eczema daily and the eczema started to gradually clear up that week. A band-aid was tested on the infant's other thigh to see if the band-aid was the cause of his reaction.  Mother left the band-aid on for over 24 hours, but no reaction was observed. 2 months after the vaccine the eczema on the infant's thigh is almost completely cleared up.  Infant also has small eczema spot on his thumb, but it was not related to the vaccine. In January of 2011, infant again had a pimply bump rash/eczema, this time 2 days after receiving his 3rd dose of Pentacel (which he had previously had no reaction to).
Began to have hives after 2nd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 22Apr2021 00:30 (Batch/Lot number: unknown) at the age of 28 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Pulmonary sequestration" (unspecified if ongoing); "Ovarian cysts" (unspecified if ongoing); "allergy" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA; JUNEL FE 1/20; VITAMIN D2. Vaccination history included: BNT162B2 (Dose Number: 1, Batch/Lot No: EP7533, Location of injection: Arm Left, Vaccine Administration Time: 10:15 AM), administration date: 31Mar2021, when the patient was 28 years old, for COVID-19 immunisation. The following information was reported: URTICARIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Began to have hives after 2nd dose". Therapeutic measures were taken as a result of urticaria.  Additional information: This report was received via COVAES. The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient's concomitant medications ALLEGRA; JUNEL FE 1/20; VITAMIN D2 were taken for an unspecified indication, start and stop dates were not reported. The event hives got better after taking Allegra daily. The patient also received PNEUMOCOCCAL 13 VALENT VACCINE administered in left arm on 29Oct2021 as dose 1 for an unspecified indication. The patient received the 3rd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in left arm on 18Nov2021 at 17:30 (Batch/Lot number: F51611) for COVID-19 immunisation and experienced hives again, on arm, face, chest, a little itchy but not serious.  The lot number for BNT162B2 was not provided and will be requested during follow up.
9/10/21: SNEEZING, CHILLS, FATIGUE, TASTE NOT NORMAL, NO SMELL
PASSED AWAY; COVID-19; This spontaneous report received from a physician concerned a 75 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 2 diabetes, and considered obese. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in JUL-2021 (a month prior to this report), the patient had covid-19 was sent home from the hospital with no treatment and told to quarantine. He was seemingly getting better, but after a few days his condition worsened and the ambulance would not pick him up. The patient decided and tried himself to sleep, but unfortunately on 09-AUG-2021, he passed away in sleep. The patient died from unknown cause of death on 09-AUG-2021. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient passed away on 09-AUG-2021, and the outcome of covid-19 was not reported. This report was serious (Death).; Sender's Comments: V0: 20210817359-COVID-19 VACCINE AD26.COV2.S.- Passed away. This event is considered unassessable. The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Soreness of lymph node in left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Soreness of lymph node in left arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Soreness of lymph node in left arm). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Soreness of lymph node in left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to MOD-2021-223729 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Additional information received on 16 Jun 2021 contains second dose information, added reporter E mail ID, updated re-challenge from not applicable to negative.
This spontaneous report as received from a consumer refers to one of her 3 grandchildren of unknown age. It was reported that the patient may have received GARDASIL (lot # not reported) outside of the dosing schedule. The reporter was unaware of the dates when the patient received the GARDASIL injections. No adverse effect reported. Whether the patient sought for medical attention was not reported. The outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Swelling of my tongue and throat. The second and third days I was unable to stand or walk  without assistance and was extremely tired and also had memory lapses.
Same night after the shot, I noticed a small, raised, red bump below injection site.  Nothing at actual injection site, but likely where the syringe was inserted and vaccine entered body.  That went away within a day or so.  Some site soreness, but similar to other vaccines like Tetanus.  A day or so after the vaccine, I developed a rash about the size of a silver dollar pancake.  The rash was red, but not raised.  The rash was itchy occasionally.  The rash remained for about 10-14 days after vaccination.  It gradually faded in redness and itchiness.  It was not very bothersome and topical creams helped, but I wanted to report.
April - 25: fatigue  April 26: body aches, headache, nausea, fatigue April  April 27: vertigo, body aches, fatigue,  headache, nausea, Shingles pain and mild rash
Around 1230pm I started to itch, then got nausea, then felt palpitations, checked my own heart rate using and I watch and heart rate was on svt with a rate of 160. I held my breath and heart rate came down after 5 min to a rate of 80 Sinus rhythm.
Pt c/o feeling lightheaded,  "seeing spots" 10min s/p covid-19 vaccine.   Pt notes that sx exactly the same as he experiences with blood draws,  blood donations.  NO LOC.   EASED TO SUPIME POSITION.   VITALS AS NOTED.   SX RESOLVED W/O TX,   VITALS AS NOTED.   ADVISED TO NOTIFY STAFF OF THIS NEAR SYNCOPAL EPISODE WHEN HE RETURNS FOR DOSE #2.     10:50  BP 89/52 10:55  BP  92/56  IMPROVED 10:59  BP  116/74  ASYMPTOMATIC DX: NEAR SYNCOPE POST VACCINATION.  RESOLVED.
redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2022, the patient received the 1st dose of Shingrix. On 9th June 2022, less than a day after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-JUN-2022 Reporter's Comments:  The patient reported case for herself. The patient received her dose of Shingrix and stated that evening after vaccination she noticed some redness at the injection site. The symptom was not resolved. Provided medical advise disclaimer and referred to health care professional. The reporter did not consent to follow up.
Based on lab report unknown symptoms started on 7/17/21. 2019 Coronavirus SARS-CoV-2 Rapid~2019 Coronavirus SARS-CoV-2 Rapid test performed on 7/17/21 and came back positive. Case investigation interview with patient has not been performed as of the time of this written note.
Patient mentioned that her son tested positive last Friday and so they were exposed; This is a spontaneous report received from a Pfizer Sponsored Program . A contactable consumer (patient herself) reported that an unspecified aged female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient mentioned that her son tested positive last Friday and so they were exposed. So she wants to know if it's okay to take the 2nd dose today, or do they need to delay the schedule. The outcome of the event was unknown.  No follow up attempts are needed. No further information is expected.
Child began spiking a temp, first noted to be 101.4. This has continued until current date of 12/22/2014. Tylenol will not bring fever down, ibuprofen at dose for weight of 22lbs will bring fever down to 99. Also began sneezing, thick phlegm and wheezing with cough. Child has croup like cough since admin of Nasal flu vaccine. Child not wanting to eat, drink. Slightly lethargic, when fever controlled child is more active and will take PO pedia-lyte or Popsicles. Will be seeing medical treatment on 12/22/2014 related to symptoms.
arm red/swollen;allerg rxn to med;tx cool compresses, motrin, DPH
I received my 2nd shingles shot I was told of body aches, fatigue etc. 36 hours after shot feeling sore head to toe, I discovered an enlarged lymph gland on my collar bone, same side as shot. I notified my physician who said swollen glands can happen after a vaccine. it was not one of the symptoms on the patient reaction page so it alarmed me