chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The day of my vaccine I developed a purple tingling in my toe on my right food next to my big toe, about 3 hours after administration of the vaccine. .  My toe then turned purple and swolen for two weeks.  My toe was almost fully healed by 2/22/2023.  On 2/22/2023, I noticed that I started to break out into non localized hives all over my body.. These hives will occur randomly and itch. If I start breaking out randomly, and I put lotion on my face ore use a towel I seem to break out.  Taking Zyrtec has helped with itching. I have also been put on steroids, Presidone for 6 days. My hives have started to get better with the combination of zyrtec and presisdone. They are still not gone though and it is 3/13/2023. I have been having non-localized outbreaks since 2/22/2023. They do seem to be getting better.  I am meeting with a dermatologist tomorrow.
Information was received from a registered nurse concerning an approximately 11 year old patient who was "deficient in pneumococcal antibodies" who an approximately 05 APR 2005 was vaccinated with a dose of PPV.  Subsequently the patient developed swelling and erythema.  Unspecified medical attention was sought.  The treatment was unknown.  The patient was not hospitalized.  The patient was reported to be recovering.  No product quality complaint was involved.    Additional information was requested.  it was also noted that another child was vaccinated with PPV and developed adverse events.
DEAD; This spontaneous report received from a company representative via social media concerned over 300 multiple patients of unspecified race and ethnicity. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.   On an unspecified date, reporter stated "over 300 dead athletes perhaps" . On an unspecified date, the patients died from unknown cause of death. It was unknown if an autopsy was performed (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220126450, 20220126177, 20220126708, 20220126614, 20220126211, 20220126174 and 20220126701.; Sender's Comments: V0: 20220126582 -Covid-19 vaccine ad26.cov2.s- Dead. This event is considered unassessable. The event has a compatible/suggestive 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
Patient stated  she had a reaction to the SHINGRIX vaccine in which she experienced fever, headache, nausea and chills. She had an injection site reaction and her upper arm became red and hot to the touch. Patient stated it was just a little bit itchy. Her symptoms lasted around 48 hours. She has never had a reaction to a vaccine in the past. She noted that these were all reactions listed that may happen but wanted to report the reaction she experienced because it was out of the ordinary for her since she has never had any reaction to other vaccines in the past.
This is a spontaneous report from a contactable nurse. An 89-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) 0.3 mL via intramuscular route of administration in the left arm on 19Feb2021 (at the age of 89-years-old) as a single dose for COVID-19 immunisation. Medical history included Congestive Heart Failure (CHF), tricuspid and mitral valve regurgitation, hyperlipidemia, hypertension, Gastroesophageal Reflux Disease (GERD), osteopenia, chronic dorsalgia, chronic lumbago, left partial lobectomy related to blastomycosis in 1967 and hysterectomy. The patient was allergic to iodine contrast media and iodine containing multivitamin. Concomitant medications included paracetamol (ACETAMINOPHEN), amitriptyline (MANUFACTURER UNKNOWN), butalbital, caffeine, paracetamol (FIORICET), colecalciferol, calcium phosphate (CALCIUM+D), hydrocodone, paracetamol (APAP;HYDROCODONE), furosemide (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN), potassium (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B12), senna alexandrina (SENNA) and multivitamins (MANUFACTURER UNKNOWN), all the above taken daily and alendronate sodium (FOSAMAX), taken once weekly; all the medications were taken for unspecified indications from unknown dates. 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. On 27Feb2021, after the second immunisation, the patient experienced zoster rash left mid T-spine, wrapping to under axilla and under breast. Care required 4 weekly visits and antibiotic, until rash was resolved. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with lidoderm pain patch; cellulitis occurred under patch/zoster which included treatment with oral antibiotic and monitoring. The clinical outcome of the event zoster rash was resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
ZOSTAVAX given to 5 year old without complications. Called patients mom on 5/23/09 & 5/26/09
nodule at the injection; Nodule was tender; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site nodule in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA933A, expiry date 30-JUN-2024) for prophylaxis.   On 11-JUL-2023, the patient received the 1st dose of Menveo (injection, left deltoid). On 12-JUL-2023, 1 days after receiving Menveo, the patient experienced injection site nodule (Verbatim: nodule at the injection) and injection site tenderness (Verbatim: Nodule was tender). The patient was treated with ibuprofen. The outcome of the injection site nodule and injection site tenderness were unknown.   It was unknown if the reporter considered the injection site nodule and injection site tenderness to be related to Menveo.     It was unknown if the company considered the injection site nodule and injection site tenderness to be related to Menveo.   Additional Information: GSK receipt date: 13-Jul-2023 The patient age was reported as 11 years. The medical assistant called for a minor child. The next day the child's parents called doctor's office to report a nodule at the injection site the size of a half lemon.   The nodule was tender to the touch, not warm, and not red.   Treatment recommended by office physician was cool compresses and Ibuprofen as needed. The reporter consented to follow up. This case is linked with US2023096266, by same reporter.; Sender's Comments:  US-GSK-US2023096266:Same reporter
Overall malaise, sore arm, since vaccine admin. on 8/3/16. Fever, joint pain.
Rash rash on chest/chest tightness Narrative:  The patient required benadryl and monitoring in the emergency department for further allergic reaction. The patient required prescription for prednisone and benadryl at time of her discharge. The patient required a second visit to an urgent care due to mouth ulcers on 1/4/21
Low grade fever, arm and body soreness, redness at injection site about the size of a saucer, warmth at injection site
RMA was giving patient injection when the needle came apart from syringe. Needle was "dropsafe" 25 gauge 1 inch needle lot number 0325250001 expiration 08/11/2025 Only partial dose of the Moderna was given. Unclear of the total amount given.  MDH was notified and we were advised to administer another dose immediately.
Pulse 80 Feels faint/ dizzy/ light headed/shaky No loss of consciousness BP 108/70 Observed 30 mins Paramedics consulted. All symptoms resolved < 30 mins.
Mom called office today 09/07/2022 to let us know she took patient to ER because patients' body was getting a rash  all over body and body was swollen with both eyes swollen shut.
Sharp pain on the side of my head that caused my ear to swell on the Right Side and then cause numbness.
Information has been received from a registered nurse referring to unknown patients of unknown age and gender. There was no concurrent condition or medical history reported. On an unknown date the patients were vaccinated with GARDASIL 9 (lot # L018351, expiration date 11-AUG-2017 and lot # L045711, expiration date 08-MAY-2017) (dosage, strength and route unknown). The vaccines were stored in temperature 1.65 degree centigrade for 15 minutes, 1.79 degree centigrade for 10 hours and 9.62 degree centigrade for 10 hours. No adverse effects was reported. Additional information has been requested.
EXCRUCIATING LOWER BACK PAIN; HOT AND COLD FLASHES; TIRED; HEADACHE; This spontaneous report received from a patient concerned a 36 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced hot and cold flashes. On 08-APR-2021, the subject experienced tired. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced excruciating lower back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot and cold flashes, tired, and headache on APR-2021, and had not recovered from excruciating lower back pain. This report was non-serious.
None stated.  6/22/09 Autopsy report received DOS 4/22/09. Cause of Death: Sudden Infant Death Syndrome (SIDS). Manner of Death: Natural.
While sitting in observation over 30 min. pt developed bilateral arm redness. On assessment patient tachycardic HR 110 BP 126/90. 02 sat 97%. RR 20. Pt. c/o chest tightness and difficulty breathing as well as tingling of mouth and tongue. Face flushed. EMS activated and took patient into ambulance within 1 minute. Nurse followed up with patient later in the day, patient reported she declined EMS transport due to cost. Patient stated she went home and followed her allergy protocol and breathing easier during phone conversation. Instructed to call EMS and use EPI pen if breathing was getting difficult to manage at home.
This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2FEB2021 (lot number 007M20A, expiration date unknown), 19MAR2021 (lot number 001B21A,expiration date unknown)) and NO ADVERSE EVENT (No adverse event) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 007M20A) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2FEB2021 (lot number 007M20A, expiration date unknown), 19MAR2021 (lot number 001B21A,expiration date unknown)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2FEB2021 (lot number 007M20A, expiration date unknown), 19MAR2021 (lot number 001B21A,expiration date unknown)) and NO ADVERSE EVENT (No adverse event) outcome was unknown. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2022-630544 (Patient Link).
Pfizer COVID vaccine #3 given 8/22/21, lot # FC3183; 2/5/22 pt had a positive COVID home test; 2/6/22 went to urgent care and was referred to hospital ED for low O2 sats (80s); admitted 2/6 - 2/8/22 and was given dexamethasone, remdesivir, O2; dc'd to home; since then has had watery diarrhea, fatigue, poor oral intake, more labored breathing; 2/15/21 pt back to ED; admitted with COVID pneumonia, AHRF, A Fib with RVR, AKI and supratherapeutic INR; ICU; was in DIC and received cryoprecipitate; given ABX; pt's condition continued to worsen and he was transitioned to comfort care; he passed away in the hospital
15 minutes after injection, client collapsed and hit his head on the wall.  He was placed in shock position on the floor.  BP started to go down.  c/o horrible chest pain, afraid he would die, very pale, red rash around eyes, short of breath.  Epinephrine given and BP increased, rash relieved around eyes, chest pain relieved, and breathing returned to normal after he recieved epinephrine.
Fever 101.5 Same Night as shot (Expected Fever) next day=Rapid heart, weak, chest discomfort Lightheaded. Lasted til Emergency Room 9-26-19 came back 9-28-19
Pin and needles right side of scalp over ear and down neck in spine,3 days loss of bladder control 24 hrs. Uncontrolled appetite I?ve a month
Reaction to first dose of SHINGRIX; local site pain and swelling. Reaction to second dose of SHINGRIX included: local site pain and swelling, shivering whole night after vaccination, splitting headache, nausea, back pains and some body aches.
The patient received a third dose of Moderna only 4 months after receiving their second dose. The incident happened today and there were no adverse events reported while the patient was still in the pharmacy building. The patient was warned to contact their doctor and complete a VAERS report if any unusual symptoms arise after receiving the early dose.
Myocardium/pounding heart episodes started 3 days after second dose; Reaction and illness lasted one week; This is a spontaneous report from a contactable consumer (patient, self-reported). A 70-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Right, on 10Jun2021 at 14:30 PM (age at vaccination: 70 years), as a single dose for COVID-19 immunization at pharmacy or drug store. The patient's medical history and concomitant medications were not reported. The patient did not have known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Right, on an unspecified date in 2021 at 02:30 PM (age at vaccination: 70 years), as a single dose for COVID-19 immunization at pharmacy or drug store. The patient reported that on 13Jun2021 at 03:30 PM, he experienced myocardium/pounding heart episodes started 3 days after second dose and reaction and illness lasted one week. The patient did not receive treatment for the adverse event. Outcome of the events was recovering.  Information regarding the lot/batch number has been requested.
Other complications following immunization, not elsewhere classified, initial encounter on 2022-01-14.
Muscle pain; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was captured as an adult as per vaccine indication. The patient received dose of Shingrix and experienced muscle pain. The reporter inquired that how long would the muscle pain last after the 2nd dose and was there anything could take to ease the pain. The follow-up would not possible as no contact details were available.
On the left side of my body I have developed rashes; fluid filled blisters; These blisters in turn would pop and turn into bruises; pain from the skin down to her bone; severe pain in her arm; This case was reported by a consumer and described the occurrence of rash in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, couple of days after receiving Shingrix, the patient experienced rash, blister, contusion, pain and pain in arm. On an unknown date, the outcome of the rash, blister, contusion, pain and pain in arm were unknown.   The reporter considered the rash, blister, contusion and pain to be related to Shingrix. It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: Couple of days after vaccination with dose of Shingrix, the patient had rash on left side of the body as well as fluid filled blisters. These blisters in turn would pop and turn into bruises. The patient had severe pain from  the skin down to bone where the blisters were occurring. The blisters were all on the left side of body, arm, breast and stomach. The blisters on breast and stomach have started drying up and the pain is improving, but still having severe pain in arm. The pain has been preventing from sleeping. The patient went to emergency room  and was told having an adverse reaction to Shingrix. The reporter consented to follow up.
Approx 10 minutes after vaccination,  patient in waiting area noted L arm tingling, head feeling "fuzzy" and blurriness to vision L eye only
pt  had fever and chills the day after the shot. Then Friday (2 days post) she developed petechiae on her legs and feet. She has had it before but usually only on her feet when her shoes/socks are too tight. Today is Sunday. She still is experiencing this. She has a cardiologist appt tomorrow and will have him look at it.
Severe insomnia, severe brain fog, sinus pain, sore throat, shortness of breath, body aches and tingling, eye irritation, blurred vision, headaches, stomach discomfort.
Approx. 5mm palpable, non-tender area of swelling at injection site. No treatment required, resolved spontaneously. Appeared at site of DTAP injection.
Fatigue, bruising at inj site intermittently for 2 weeks post inj. Narrative:
3RD DOSE PFIZER COVID VACCINE GIVEN 12/20/21, LOT #FH8027. pt admitted to local Hospice on 8/7/22; admitted with multiple myeloma, sepsis secondary to pneumonia, AKI, encephalopathy; admitted for pain and dyspnea; minimally responsive; no oral intake, nonverbal, bed confined; pt found deceased in the facility; post mortem COVID PCR test was positive
Chills, sweating, jerking starting when went to bed that evening and continued for 3 days.
Patient is here from another country, was giving the patient vaccinations for attendance to school in this country.  Accidently gave the patient Daptacel instead of Adacel.  Patient and his parent were notified of mistake on 4/5/2023 at 17:08, no adverse reaction noted.  Manufacturer was contacted on 4/5/2023 at 13:53 and there is no reason to re-vaccinate and this vaccination should count as the Tdap dose for the patient.  Supervisor of medical employee was notified of mistake on 4/5/2023 at 17:55. Went over the standing orders for the vaccines and will verify vaccine and age for future vaccinations.
Severe chills; Left Deltoid administration site reaction; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 60 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 19Jan2021 (Lot number: EL1283, Expiration Date: 30Apr2021) at the age of 60 years as dose 2, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL, start date: 31Dec2020; IBUPROFEN, start date: 19Jan2021. Vaccination history included: Bnt162b2 (Dose: 1, Lot no: EJ1685, Expiry date: 31Mar2021, Dose: 0.3ml, Route of administration: Intramuscular, Anatomical location: Deltoid left), administration date: 31Dec2020, for Covid-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 20Jan2021, outcome "recovered" (Jan2021), described as "Severe chills"; VACCINATION SITE REACTION (non-serious) with onset 20Jan2021, outcome "unknown", described as "Left Deltoid administration site reaction". The action taken for bnt162b2 was unknown. Therapeutic measures were taken as a result of chills, vaccination site reaction.  Additional Information: Patient provided information to you regarding the reported adverse event with the use of the product. Patient considered the Pfizer product had a casual effect to the adverse event. Patient was willing to be contacted again by Pfizer on the reported adverse event. Did reaction recur on re-administration of product was yes; 24 hours after shot-10 hours of severe chills, injection site reaction. Additional vaccine administered on same date of Pfizer suspect was none. Family medical history relevant to AE was none Culture was not performed. Prior vaccinations (within 4 weeks) was none. There were no predisposing factors. Antipyretic use (around the date of vaccination) was Tylenol, Ibuprofen.   No follow-up attempts are possible. No further information is expected.
Chills, headache, fatigue, brain fog, difficulty sleeping. Started approximately 12 hours after injection
Vaccine Breakthrough - Severe - needing monoclonal antibodies Dose 1 - 12/24/20 Dose 2 - 1/12/21  Case was experiencing fever, chills, muscle aches, runny nose, loss of smell/taste, headache, fatigue, cough, wheezing, nausea/vomiting. Case needed to go in to the hospital, to get the monoclonal antibody infusion to help relieve her of symptoms.
10cm area of swelling & erythema on (R) thigh at site of injection.
Had vertigo 2 weeks after first dose then 1 week after second dose woke up with right ear stuffy and deaf. Went to ENT out on steroids and after a few months hearing improved some. Will be getting a hearing soon.