chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My first three days after my shot, I had typical side effects of headache, fatigue, chills, sore arm at injection site and stiff/achy legs. All the side effects subsided after three days except my legs ached along with my arms and shoulders too. The shoulder and arm pain occurs  occasionally now...every two or three days for several hours. My leg pain has not stopped. I describe the leg pain as an ache that does not have sharp pain or tingling. It is less intense if I have a sedentary day. On a normal day on a pain scale of 0-10, I rate my leg pain as a 6. Ibuprofen diminishes the pain by a small amount.
Pt was exposed to a COVID positive grandson, developed SOB and tested positive also.  Admitted to the hospital 10/27/21
Pt had rash on face, chest and legs, on and off of back X 24 hours with hives on body parts.
Hot and itchy rash across her chest and back; Itchy rash across her chest and back; Injection site soreness; This case was reported by a other health professional via call center representative and described the occurrence of heat rash in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. In September 2019, 1 day 12 hrs after receiving Shingrix, the patient experienced heat rash, itchy rash and injection site pain. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the heat rash, itchy rash and injection site pain were recovered/resolved.   It was unknown if the reporter considered the heat rash, itchy rash and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 63 years or 64 years. On an unknown date in September 2019, approximately 2 weeks ago of reporting date, the patient received her 1st Shingrix vaccine at a local pharmacy. After 36 hours of receiving the Shingrix, the patient developed a hot and itchy rash across her chest and back and injection site soreness.  The patient self treated with Benadryl and the events were resolved without medical intervention on an unknown date.  The reporter did not consent to follow-up.
A report has been received from a Health Professional concerning a 17 year old, female subject, who had been receiving FLUMIST started on an unknown date. The patient experienced patient is pregnant. The outcome of the event patient is pregnant is unknown. The report was considered to be non-serious. The reporter considered that There was no casual relationship between patient is pregnant and FLUMIST. Based on the information in this report and awaiting the reporters assessment, the company physician considered the event of patient is pregnant suspect drug FLUMIST to be unrelated.
NP ordered Varicella, MMR and Hep A vaccines for patient. LVN removed vaccines from VFC freezer to give to the MA. LVN did not notice she removed PROQUAD, thus no single dose of Varicella was ever taken from freezer. Both employees overlooked the medication error. Patient was given wrong dosage (over dose) of Varicella vaccine-MA administered PROQUAD, Varicella, MMR and Hep A. This meant Varicella was given twice, as a single dose and as a combination vaccine in the PROQUAD. All staff involved were notified and patient's mother was informed of incident. Patient monitored at the clinic and instructions were given to mother on care of child at home. Patient was called the next day as follow up on status, mother stated no adverse reactions noted. Patient was stable.
Bells Palsy affect 60 hours after injection. Right eye.....same manifestation as I had during Covid-hospitalization in 2020. Seems to be abating finally (approx 18 hrs from detection).  Severe headaches, chills and fatigue commenced approx 8 hours after injection. LAsted two days. On third day, headaches and fatigue continued, but mildly.
Low back pain; This case was reported by a consumer via interactive digital media and described the occurrence of low back pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced low back pain. On an unknown date, the outcome of the low back pain was unknown.   It was unknown if the reporter considered the low back pain to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. Consumer reported that after receiving the shingrix patient experienced low back pain. The reporter did not consent to follow up.
Patient received her vaccine and waiting for 30 minutes following vaccine with no issues reported.  About 2 hours after patient returned home, patient's outside of her mouth started to burn.  She continued to wait to see if it resolved and when it didn't, she returned to vaccine clinic.  Nurse practitioner at vaccine clinic administered 25mg PO Benadryl and had her wait another hour.  Patient was able to be discharged but continued to have itchiness and burning.  She was seen by her PCP the next day and was given a steroid shot and instructed to continue Benadryl every 6 hours.
This spontaneous report was received from a nurse and refers to a 2 year-old male patient. There was no information about the patient's pertinent medical history, drug reactions or allergies provided. On 28-JUN-2017 at 11:45, the patient was vaccinated with improperly stored VARIVAX, in the right thigh (lot # M047662 with the expiration date of 02-DEC-2018, second dose; exact dose and route of administration were not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). The patient was concomitantly vaccinated with a dose of VAQTA. There was no adverse event. The administered dose of VARIVAX experienced a temperature excursion between 9 and 25 Celsius degrees for 2 hours and 16 minutes. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. ; Sender's Comments: US-009507513-1706USA009938:
Severe red rash on face, neck, back, stomach and arms for duration of 10 days. Fever of 99.0 for duration of 1 day. Consulted primary pediatrician around 6/2/2014, and was advised to monitor rash, and if not completely gone, schedule an appointment. Redness llessened, but rash still present until 6/18/2014, scheduled appointment. Doctor diagnosed "eczema." On 6/19/2014, rash returned in more severe fashion with, dry cough, rapid nighttime breathing, extreme redness, moderate itching, and from head to toe. Another scheduled appointment on 6/20/2014 doctor diagnosed with post vaccination rash. No medication prescribed. Was suggested to administer benadryl, but has not been effective.
Patient developed vomiting episodes for days and irritable. Followed by watery black stools. Evaluated at "hospital - Pediatric (3-18-08) ED. KUB done (consisted with intussusception) ileocolic intussusception reduced with pneumatic reduction. Apnea episode (brief, did not require O2/stimulation only). EKG, UGI, echo and EEG were normal limits. Apnea episode occurred after reduction and when sleep; IV infiltrated. Discharged home in 2 days.  04/28/2008 MR received for DOS 3/18-20/2008 with D/C DX: Intussusception s/p reduction, apnea spell x1. Pt presented to ER with 3 day hx of vomiting after every meal, irritability, crying, and dark watery stool.  PE WNL. Ileocolic Intussusception noted on and reduced by Barium Enema. Pt had an episode of cyanosis s/p reduction.  W/u WNL.
had a large lump on my arm at the injection site and the area was already bruised (approximately 2 inches wide and 1 X inches in height); had a large lump on my arm at the injection site and the area was already bruised (approximately 2 inches wide and 1 X inches in height); swollen site; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported; Expiration Date: not reported), via an unspecified route of administration on 19Feb2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 29Jan2021 as dose 1, single for covid-19 immunisation. On 19Feb2021, probably 30 minutes after receiving the injection, the patient experienced a large lump on her arm at the injection site and the area was already bruised (approximately 2 inches wide and 1 x inches in height), swollen site. Perhaps, five hours later the hard lump area began to soften some. The area became slightly sore, but no pain was felt. Patient slept on left side that night and was comfortable with no pain. The patient underwent lab tests and procedures which included antibody test: negative on an unspecified date. The outcome of the events were unknown.  No follow up attempts are possible. No further information is expected.
Besides a sore arm, my armpit area became swollen to the point I could not put my arm at my side without intense pain. My armpit swelled to the size of a softball or grapefruit.  It lasted for several days.  After about 3 days the swelling started to subside.  It is now 3 weeks past and there is still minimal swelling.
Nausea, body aches, fever started around 2 PM. By 8 PM child was crying and not wanting to drink fluids. Mom is  a nurse and had him drink water and used cool cloth for fever. Temp got up to 102 even with Tylenol and Ibuprofen staggered dosing. Felt better next day and by 5 PM on 6/29 he was completely recovered.
On 12/2/2014 flu vaccine was placed on (R) top shoulder. He felt pain and fairly quickly swelled up. Pain keeps him from much work over shoulder level. He was sent to therapy.
Malaise, achy body, weakness, tiredness. Overall flu-like Sx, without fever. Chill, feels as it "Hit by a truck"
ON 1/20/21 @0600 DEVELOPED WEAKNESS, LETHARGY, EXTREME FATIGUE, AND DIMINISHED APPETITE THAT RESOLVED 1/21/21 @0800
got COVID-19 after getting his series of two COVID-19 shots/patient had been exposed to COVID-19 after taking the COVID-19 Vaccines/still positive for COVID-19 antibodies; got COVID-19 after getting his series of two COVID-19 shots/patient had been exposed to COVID-19 after taking the COVID-19 Vaccines/still positive for COVID-19 antibodies; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 76-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in right arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Dementia", start date: 2020 (unspecified if ongoing), notes: Diagnosed 3 years ago; "High cholesterol" (unspecified if ongoing), notes: Diagnosed when he was between 53-55 years of age; "Had places of skin cancer removed off of his body" (unspecified if ongoing), notes: it was several times in the last 5-10 years. There were no Family Medical History Relevant to Adverse Events.The patient's concomitant medications were not reported. There were no prior Vaccinations within 4 weeks.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got COVID-19 after getting his series of two COVID-19 shots/patient had been exposed to COVID-19 after taking the COVID-19 Vaccines/still positive for COVID-19 antibodies". It was reported that patient got COVID-19 after getting his series of two COVID-19 shots, which were manufactured by Pfizer. Patient has been testing for COVID-19 antibodies as recent as 2 months ago in Jan2023 and still positive for COVID-19 antibodies. Patient's doctor, advised since patient is testing positive for both antibodies, there is no reason for patient to get a booster at this time. That way, he could get a booster if needed. Then states, that's over 18 months ago. Caller did not specify what was over 18 months ago. Caller stating patient didn't test positive for COVID-19, it showed in his blood work. Patient's doctor said at some point, patient had been exposed to COVID-19 after taking the shots. The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) showed exposure to COVID-19; Body height: (unspecified date) Either 5ft-8in or 5fr-9in; SARS-CoV-2 antibody test: (unspecified date) Positive, notes: still positive for COVID-19 antibodies; (Jan2023) Positive, notes: testing for COVID-19 antibodies as recent as 2 months ago in Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300135810 Same reporter/drug/AE, different patient.;
No taste and smell, congestion, cough, headache, runny nose, fatigue, pale colored skin
Information has been received from a registered nurse concerning an 18 year old female who on 03-DEC-2007 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL. Subsequently the patient developed a hive like, red rash over her entire body. The patient sought unspecified medical attention. The rash lasted approximately two weeks and then resolved. Additional information has been requested.
INJ SITE RAISED AND ITCHING DAY 1-4 Narrative:  INJ SITE RAISED AND ITCHING DAY 1-4- resolved after day 4
doses 26 days apart; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number HM2YH, expiry date 25th March 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 20th October 2021, the patient received the 2nd dose of Shingrix. On 20th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were reported as follows: The pharmacist reported a patient received their 2nd dose of Shingrix 26 days apart and not the minimum two months apart from 1st dose which led to shortening of vaccination schedule. The reporter consented to follow up.
1. Got the Flu 1 day after vaccination. Treated with Augmentin and Ampicillin. 2. Got the mumps 7 days after vaccination, treated with IV steroids in emergency room, followed by 6 days of oral methylprednisolone. 3. As of 01/29/05 still not fully recovered. Follow up 02/15/05: Vaccination given at another facility, manufacturer and lot number for vaccine not available.
difficulty sleeping; Pain in the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (difficulty sleeping) and VACCINATION SITE PAIN (Pain in the site of injection) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. C13A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced INSOMNIA (difficulty sleeping) and VACCINATION SITE PAIN (Pain in the site of injection). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form. On 23-Mar-2021, INSOMNIA (difficulty sleeping) and VACCINATION SITE PAIN (Pain in the site of injection) had resolved.            No concomitant information was reported. The expiration date of both vaccines was recorded as 01Jan1900.   This case was linked to MODERNATX, INC.-MOD-2021-076259 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-076259:Dose 1
was given expired Pentacel, with no adverse event; Initial information received on 02-Nov-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 3 months old female patient who was given expired pentacel (expired product administered), while she received vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel] (batch number: UJ019AAA and expiration date: 09-Oct-2020) via unknown route in unknown administration site for prophylactic vaccination.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event expired vaccine used (latency: unknown).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: this suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module VI of the good Pharmacovigilance practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Extreme vertigo (could not do activities of daily living), blood pressure in 80s (normally 90s systolic), tachycardia 120s (normally in 50s-60s). Stayed home, drank a lot of fluids. Resolved in 48 hours without treatment
This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Caught COVID-19 this year (2022) after being vaccinated with Moderna's COVID-19) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (Caught COVID-19 this year (2022) after being vaccinated with Moderna's COVID-19). At the time of the report, COVID-19 (Caught COVID-19 this year (2022) after being vaccinated with Moderna's COVID-19) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications were reported. No additional adverse events reported. No product quality complaints reported. No treatment information was reported. Company comment: This spontaneous case concerns a female patient of unknown age, with no medical history reported, who experienced the non-serious unexpected adverse event of special interest of COVID-19 after receiving a dose of mRNA-1273 vaccine. There is no information available regarding dose number or further COVID-19 vaccination schedule. Vaccination date or event onset date were not provided; hence latency cannot be assessed. No other information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a female patient of unknown age, with no medical history reported, who experienced the non-serious unexpected adverse event of special interest of COVID-19 after receiving a dose of mRNA-1273 vaccine. There is no information available regarding dose number or further COVID-19 vaccination schedule. Vaccination date or event onset date were not provided; hence latency cannot be assessed. No other information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report.
On Sept 15th I called my PCP explaining cold like symptoms, congestion, and cough.
i received the vaccine at 5:30 pm no side affect but at midnight 12:05 I woke u with massive headache around my head and muscles pain with temp and shivering cold i could not sleep all night after also with stomach pain too and at one time i felt short of breath i did not take anything until 12:00noon the day with tylenol and i drank lots of Gatorade, i night sweat a lot and i slept all night after taking another two pills of tylenol 500 mg each, i sweat all night and I woke up good thanks god i feel much better
Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 3 month old male patient who developed a rash on the back of his head, a rash all over his body and mild eczema at site of injection. At 3 months of age the patient received the first dose on an unspecified date. The patient has a past history of eczema. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant therapy included Poliomyelitis vaccine inactivated. Allergist reported that within 24 hours following injection, the child developed mild eczema at the site of injection (date unspecified). Two days later, the patient developed a rash on the back of his head. The patients mother applied triple antibiotic cream (bacitracin/neomycin sulfate/polymyxin B sulfate). The next day the child developed a rash all over his body. Outcome is unknown. No additional information was available at the time of this report.
shingles; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HERPES ZOSTER (shingles) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jul-2021, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was reported.
Narrative: Per September 2, 2021 Physician's allergy consult note,:  A 54yo female who presented with allergy concerns had reported a historical  ADR of Flu vaccine induced drowsiness and respiratory distress which occurred in 1996 No other detail information was provided regarding the product, where it was administered or by who
complained of redness, warmth, discomfort at left site on 10/25/06 3PM. On 10/28/06 complained of pruitis at waist, abdomen, posterior thighs. Complained of "flat red blotched" on neck, shoulder and groin, leg,and swelling in hands. Went to UCC on 10/29/06 at 12 PM and was treated with SoluMedrol, Prednisone times 1 week. Complained of trace hoarseness and clearing of throat. Recovered not until 11/7/06.
Large, red welt between shoulder blades.  Irritable, low-grade fever, crying off and on more than normal.  Lasted for two weeks.